chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number: 3; Pain in arm after injection; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   An adolescent patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation and Covid 19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: UNKNOWN, Route of administration: Unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number: 3"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm after injection". It was unknown whether therapeutic measures were taken as a result of the event pain in extremity.  Additional information: It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UPON DOUBLE CHECKING PRESCRIPTIONS PER PHARMACY POLICY I DISCOVER THAT AFLURIA WAS GIVEN TO A 15 YEARS OLD CHILD. AFLURIA IS INDICATED FOR 18 YEARS AND ABOVE. PATIENT DID NOT COMPLAIN ABOUT ANY THING FOR THE 20 MINUTES SHE WAITED AFTER THE SHOT. BUT I AM REPORTING AS REQUIRED.
Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.            No concomitant medications were reported. It was reported that patient had fever after receiving the Moderna vaccine and had to stay in bed for 3 days to recover; it eventually resolved on its own. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-718094 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718094:Husband case
Day 1 after vaccine abdominal pain started. Day 2 diarrhea started and still continues (day 8 today) Day 4 vomiting started and still continues.  Diarrhea is bloody. Low grade temperatures but no high fevers.
Head spinning/ dizziness  Severe Bile water diarrhea:4-6 time/hour
14 patient administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported.In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No concomitant medications were provided.No treatment medications were provided.Patient has reported that she doesn't have allergy history and ever tested  positive for COVID-19. In addition, reported that she dose not have cute illness at of time of vaccination, and chronic health conditions as well.This case was linked to MOD-2021-385976 (Patient Link).
About 24 hours after the injection, I got really sick with aches from the tips of my toes to the ends of my hair. Headache, nausea, pain in all joints and the injection site was extremely sore. It lasted about 6 hours. It was really bad. I have a high tolerance for pain, but this was a level 8 on a scale of 10. The headache lasted two more days. A little lightheadedness and dizzy feelings, but over all good to go and do my daily activities. Friday, 0205/2021, I had major diarrhea and vomiting around 9 PM. Back to normal on Saturday. Today, Sunday, 02/07/2021, I am experiencing itching and burning, with swelling and redness at the injection site and a bit of nausea, with a low amount of diarrhea. I still feel pretty okay with a tiny headache. This entire time from the 6 hours of real pain, I am fatigued and really tired after very little activity. No shortness of breath or coughing though.  I get my second shot on 02/26/2021. I also have my 6 month check up tomorrow, Monday, 02/08/2021 with Dr.
Having numbness on the left side, this is the same side where she get the, received the vaccine on/Tingling in her arms and her fingers and in her leg and also the numbness; Tingling in her arms and her fingers and in her leg; she is having some complication and side effects from taking the Pfizer (Covid-19 Vaccine); This is a spontaneous report from a contactable consumer. This consumer(parent) reported for 24-year-old female patient(daughter) that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0198) via an unspecified route of administration on an unknown date in Jul2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On an unknown date in Jul2021 the patient had numbness on the left side, this was the same side where she received the vaccine on, she had tingling in her arms and her fingers and in her leg and also the numbness and complication and side effects from taking the Pfizer (Covid-19 Vaccine). The patient had not recovered. Reporter stated, that patient had reported some of the side effects, the side effects is not listed. So, will need to inform you all this and to also know, to see exactly what can be done about it. Reporter was provided with the number of Pfizer Medical Information.  QR Comment: Due to poor internet connectivity issue at Call handlers end, voice did not get through to the caller.
The patient had been transferred to jail from another prison on 2/17/21.  Prior to his transfer, he had received the first dose of Moderna vaccine on 2/3/21.  On 3/3/21, instead of receiving the second dose of Moderna, he received a dose of Pfizer-BioNTech vaccine by a RN.
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # M016193, expiry date: 24-APR-2018). On an unknown date, the vaccine was exposed to temperatures of 47 degrees F to 77 degrees F for 108 hours. No adverse effects reported. Previous temperature excursion occurred on an unknown date between temperatures of 47 degrees F to 77 degrees F for 28 hours. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information to report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010536:
12/05/2021- I had my original seizure in July/2021,  I had 3 seizures since. Then on 12/05/2021 I had  a focal seizure, I went to the hospital and was tested for Covid-19- and was positive, I was Asymptomatic. I was 23 hour observation in the ED.
Nausea, weight loss (20 lbs), brain fog, rash, metallic taste in mouth and on fingers, dizziness,
Given ZOSTAVAX vaccine. Patient had received previous ZOSTAVAX vaccine on 12/18/2015.
ithe patient was injected with only liquid component of the Pentacel vaccine, no adverse event; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case is linked to case 2020SA121416 (same reporter).  This case involves a one month old patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6615AA and expiration date) via an unknown route in the right thigh on 23-Apr-2020 for prophylactic vaccination. However, the patient was injected with only the liquid component of the pentacel vaccine.  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  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.
03/04/2021 Shortness of breath, became very fatigue and nauseated and diarrhea. I was sick for 5 days. 3/25/2021 I have very hard time breathing. Oncology informed to get to the emergency. 03/25/2021 Went to the emergency room.
Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled speech and confusion. Taken to ED and evaluated for acute stroke, TPA given. CT was not definitive. Weakness was R>L. Pt confusion worsened a bit into evening of day of event, but by the following morning pt had returned to baseline. Is an independent 89 yo who otherwise lives at home alone and is highly functioning.  Pt did have a recent kyphoploasty and SI joint injection (perhaps with steroids/lidocaine).  Currently patient hospitalized, expected discharge soon, only complaint is tingling in fingers.... we believe this may have been coincidental, but due to time course are reporting here.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 61-year-old female patient who received BOOSTRIX. Concurrent medical conditions included type II Diabetes mellitus and Asthma. Concomitant products included ramipril, medication unkonwn, PROZAC and statin (NOS). On 5th January 2015 12:00, the patient received BOOSTRIX (injection) .5 ml. On 6th January 2015, 1 days after receiving BOOSTRIX, the patient experienced feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough. On an unknown date, the outcome of the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough were recovering/resolving. The reporter considered the feeling unwell, general body pain, dry cough, Influenza-like symptoms, fever, fatigue and productive cough to be almost certainly related to BOOSTRIX. This was 1 of the 2 cases received from the same reporter and same family. Additional details provided: The caller reports reported that the patient felt like she had a low grade fever.
Forgot to check expiration date before administering vaccine. Pt had no adverse reaction and came in a few hour later to receive an un expired vaccine.
migraine; Severe Headache for 4 days and continuing.; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Jul2021 at 10:30 (at the age of 30 years old) (Batch/Lot Number: EW0179) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 12Mar2021 to 22Mar2021, pineapple allergy from an unknown date and unknown if ongoing, and penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; and ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on10Jun2021 at 12:15pm (at the age of 30 years old) (lot number: EW0169/ expiration date: not provided) as a single dose in the left arm for Covid-19 immunizzation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Jul2021 at 03:00, the patient experienced migraine (disability) which required a physician's office visit and severe headache for 4 days and continuing. Therapeutic measures were taken as a result of migraine included magnesium supplement. The patient did not receive treatment for the event headache. The outcome of the event migraine was recovered with sequel. The outcome of the event headache was not recovered.
unknown specifics of vaccine info such as dates of administration and lot numbers. patient admitted with diagnosis of covid breakthrough
Fever blisters, chills, fever, aching vomiting, leg cramps-flu like sx;
Slightly elevated temperature, chills, felt like I was getting a cold.  Resolved on its own without intervention.
Information has been received from a physician concerning a 20 years old female who was vaccinated with GARDASIL three times: 1st dose given on 25-Sep-2007 (Lot# 65439/0742U), 2nd dose given on 27-Nov-2007 (Lot# 655322/1211U), 3rd dose given on 08-Apr-2008 (Lot# 0151X). No other vaccine administered. Concomitant therapy included ORTHO TRI-CYCLEN. On 08-May-2009 the patient had a Pap test done which come back abnormal. The physician reported that the result of the patient's test was that she had a high risk of GARDASIL, but the specific type of GARDASIL had not been determined. The status of the patient was unknown at the report time, and the patient had been outside the country. Additional information has been requested.
Hives and swelling of the airway-Given Benadryl and set to Primary Care Provider who gave her oral steroids.
Right ear became very swollen and purple, filled with fluid on outer edges, approx 1" fat, after 3 weeks, dried up and now has "cauliflower ear" like boxers. Entire groin, penis, inner thighs turned very purple, lasted about 2 weeks.  This is the site he had a severe MRSA infection when he was 5 years old.
pt brought to ED via EMS after falling, was unresponsive; pt lives in a group home; pt has vomited and has a cough; found to be positive for COVID; multifocal pneumonia; DNR/DNI; blood cultures positive for MRSA; ABX given; transitioned to comfort measures only; asystole; pt passed away in the ED
flu like symptoms, chills, hot flashes, headache, fatigue, body ache, muscle soreness, night sweats, sore/swollen throat, swollen neck lymph nodes
Arm pain then fainted, felt clammy and woke up feeing nauseuos and tired. Nurse called Dr. and brought smelling salts - both Dr and nurse talked with patient - nurse brought water and took temperature at parent's request.
Extremely Fatigued, Migraine, Arm Soreness, Fever, Cold Sweats. Body Aches, Dizziness, Hallucinations, Problems with Perception
23MAR91 employee broke out in rash, on chest & arms; Pain in joints of hands;
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. In May and June 2017, the patients were vaccinated with ROTATEQ lot # N000175, oral for prophylaxis. In May and June 2017, the patients experienced incorrect product storage. On an unknown date, the patients experienced no adverse event.  This is one of 3 reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA009479: US-009507513-1708USA009379:
Brief spells of fever like warming of body multiple times throughout day.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration on 01Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient had brief spells of fever-like warming of body multiple times throughout day. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event brief spells of fever-like warming of body multiple times throughout day was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue and mood change. SHINGRIX was discontinued. On an unknown date, the outcome of the fatigue and mood change were unknown. It was unknown if the reporter considered the fatigue and mood change to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient received one dose of SHINGRIX and was still complained of fatigue and mood was different up to 30 days after receiving the first dose. The patient did not want to receive the 2nd dose. The healthcare professional did not have any other information at the time of call. This case has been linked with case US2018107242, reported by same reporter.
Patient received a booster dose of 0.5ml, a full dose.; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 031M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.). On 05-Nov-2021, ACCIDENTAL OVERDOSE (Patient received a booster dose of 0.5ml, a full dose.) had resolved.            It was reported that the patient received booster dose because she had some medical issues.  No concomitant medications were reported. No treatment medications were reported.
Joint pain, inflamatory joints, right shoulder pain (I had surgery), loss of memory, allergies, gain weight, had therapy, pills, etc... 02/02/2010 Inflammatory joint changes.
Initial report was received from a healthcare professional on 22 November 2011. A 57-year-old female patient had received an intramuscular (IM) injection of FLUZONE; lot number UT473AB in left deltoid on 14 November 2011. On the same day of the injection, the patient stated that the needle hurt when it went in. On 16 November 2011, the patient could not raise her left arm; she also developed swelling and soreness at the site. No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none. Follow up information received on 11 June 2012: The outcome of events was updated to unknown.
Minutes after vaccination, patient complained of nausea. Was on his way to the bathroom, when he collapsed.  Patient was cold, clammy and diaphoretic.  Weak but responsive.  BP 70/40. Continued to complain of nausea but no vomiting. Paramedic onsite. IV fluids initiated and patient was transported to Hospital via ambulance.  Stabilized in hospital and discharged that evening.
During the pandemic, second dose ten months after first; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date ten months ago from 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that during the pandemic he/she was unable to get the 2nd dose of Shingrix until ten months after the 1st dose. The patient enquired if the coverage would be the same as gotten the 2nd dose within two to six months.
After administration of last injection (PREVNAR in right thigh) patient had a vagal episode and briefly appeared not to be breathing. While rubbing sternum patient began crying. Doctor came in and listened to patient's heartbeat and stated that patient was fine.
INSOMNIA; This spontaneous report received from a consumer concerned an adult male. 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insomnia was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422203 and 20210422882.