chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Registered Nurse via a company representative, referring to a 16 year old female patient. The patient had none pertinent medical history, concurrent conditions or drug reactions. The patients concomitant therapy included "menicol".    On 29-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly, lot # N015087 and expiration date on 20-OCT-2019 (dose and anatomy location were not provided) for prophylaxis. On the same day (reported as "later that night), the patient started vomiting. It was reported that, the patient called the nurse, however she did not receive treatment for the adverse event and none laboratory diagnostic studies were performed. At the reporting time, the patient had recovered form vomiting on 30-NOV-2017 (reported as "the morning of the following day") and the causality assessment between GARDASIL 9 and the event was unknown.
Maculopapular rash on both arms, more on right arm, more on forearms
2nd dose: arm sore ~3hrs post injection. 10hrs post injection, very cold. fingers and toes were freezing. started low grade fever. body aches throughout the first night, along with occasional chills. fever fluctuated ~100-101*F. high of 102.6*F. woke up every 15 minutes throughout the night. next morning (22hrs) woke up with a headache. fatigued because did not sleep well. arm soreness fading. low grade fever ~99-100 all day. legs were numb. lasted a few hours. second night (36hrs) started heart palpitations and both arms were numb. woke up next day (48hrs) and palpitations and arm numbness still present. fever gone. but fatigued and general malaise all day. extreme neck and shoulder joint pain (54hrs). took 2 ibuprofens (60hrs) and went to bed. woke up (72hrs) with neck ache. neck ache still present today (99hrs post injection).
This spontaneous report as received from a Certified medical assistant who refers to a patient of unknown age. On 27-SEP-2013, the patient received an expired dose of ROTATEQ oral suspension 2 (lot # 0050AE expiration date 30-AUG-2013) (dose and indication were not reported. No known adverse effects. Additional information has been requested.
After about 10 hours after the vaccine was administered, I got a fever of 102, which then made its way up to 104.7. I knew the fever was a possible side effect, but it got very bad very quickly. I had to call off of work because I could not stay awake and was in so much pain. My fever has lowered 2 days after vaccination, but has not fully gone down.  Also, my neck on the side that my vaccine was administered (the left arm) is very swollen and very painful. I cannot lift my arm and there is a noticeable difference between my left and my right neck in regards to swelling.
Fecal impaction n managed with manual disimpaction and laxatives. Complicated by urinary retention.
Patient complains of pain at upper epigastric areas that is sharp and discomforting. Start shortly after vaccination.
Tdap was administered in Lt Deltoid on 7/9/07. Pt recently noticed a swelling or "whelp" on the upper arm below when the injection was given. There was no redness or itching only swelling. There was also s small amount of redness and slight swelling of the injection site.
12 hours after injection, noticed l mild right arm soreness, along with fatigue and chills.  18 hours after injections, body aches,  joint (back and hips mostly) pain, and severe chills.  Low grade 100.4 F fever and malaise / fatigue. Symptoms all resolved, except mild fatigue, after 24 hours
Information has been received from a health care professional concerning a female (age unknown), who was vaccinated with a dose of GARDASIL.  Subsequently, the patient experienced neurological changes and had difficulty walking.  It was reported that she would not receive her third dose.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  The reporter considered the neurological changes and difficulty walking to be disabling.  Additional information is not available.
Delirium/had taken over her body and was the cause of her illness; Severe weakness (could not walk or get out of a chair); Severe weakness (could not walk or get out of a chair); Nausea; Diarrhea; Mild headache; Blurred vision; Significant swelling at injection site which spread to full upper arm; Significant swelling at injection site which spread to full upper arm; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 05Mar2021 08:00 (lot number: EN6199) as single dose for COVID-19 immunisation. Medical history included osteoporosis (not bothersome), known allergies to some antibiotics, and felt dehydrated. The patient was not pregnant at the time of vaccination. The patient was taking other medications like grapefruit juice. The patient previously received first dose of bnt162b2 on 12Feb2021 (dose number 1, lot number: EL9267, administration time: 08:00 AM, vaccine location: left arm). No other vaccines received four weeks prior to COVID vaccination. On 05Mar2021 12:30, the patient experienced severe weakness (could not walk or get out of a chair), delirium (was convinced that (name) had taken over her body and was the cause of her illness), nausea, diarrhea, mild headache, blurred vision, significant swelling at injection site which spread to full upper arm over next three days and remains troublesome. Other symptoms (unspecified) lessened within two to three days and are no longer of concern. The AEs resulted in doctor or other healthcare professional office/clinic visit. Event 'significant swelling at injection site which spread to full upper arm' were treated with application of steroid cream (for arm only). Outcome of the events was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination.
Arm is sore, now it's through my chest; I do not go anywhere and I lay on my bed because my chest is sore; Arm is sore, now it's through my chest; I do not go anywhere and I lay on my bed because my chest is sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported as consumer stated, "It's been 3 days ago I had shot (unspecified medication) in my arm and next day two days later my arm is sore, now it's through my chest." And it was reported as "I do sit, I do not go I lay on my bed, I watch TV and I am not going anywhere because my chest is sore." The outcome of the events was unknown.  Information about batch/ lot number has been requested.
I developed difficulty swallowing, hoarseness, loss of voice, increased heart rate in june 2021 from unknown cause. This persisted for more than 3 months without improvement. I also had feeling of fluid in chest. I had chest  CT showed multiple inflammatory nodules in my lungs. I contracted covid and had no symptoms of covid. 3 weeks later i developed chest pain and sob. these sypmtpms improved short term with dexamethasone. the symptoms has persisted and i am seeing a cardiologust who is treated me presently with colchicine and nsaids. i have also required prednisone on and off.
a raised hot erythematous lesion around the injection site on her left deltoid; a raised hot erythematous lesion around the injection site on her left deltoid; This is spontaneous report received from contactable Physician. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at left deltoid on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported. The Medical Assistant (patient) had a raised hot erythematous lesion around the injection site on her left deltoid in Apr2021. It appeared to be subsiding somewhat today 06Apr2021. The Medical Assistant got the shot Friday 02Apr2021. Outcome of event was recovering.    No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
41-year-old pregnant patient received a dose of Arexvy; 41-year-old pregnant patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 34HY5, expiry date 02-FEB-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 31-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist called to inform that a 41-year-old pregnant patient received a dose of Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
On December 8, I started having a slight headache I felt rundown and just not good. Friday morning, I started having body aches. I went to the walk in clinic and was negative and then Saturday I tested again and was positive, I was prescribed prednisone and didn't get worse just body aches and coughing but I didn't get worse.
Initially, within the first 24 hours patient had slight aches and chills. This was to be expected.  52 hours after receiving the vaccine and feeling completely back to normal the entire day, suddenly had a onset of uncontrollable chattering of jaw. This chattering moved into her body and she started shivering uncontrollably. Fortunately the symptoms subsided around 20 minutes after taking an Ibuprofen.
This spontaneous report as received from a pharmacist, refers to a patient of unknown age and gender. On 19-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 1119AA, expiration date 12-JUL-2013), (dose and route not reported). No adverse effect reported. Additional information has been requested.
Pt is a 4 month old boy who came in for his well child check. He needed Dtap #2, IPV #2 and COMVAX, also PREVNAR. In the order sheet I erroneously marked COMVAX (Hep B/Hib) and Hib in addition to the rest, except I did not mark IPV. Pt got both COMVAX and Hib - 2 dose of Hib, different sites- Hib-left thigh, COMVAX-right thigh. Pt was clinically well. No adverse events noted after administration.
PATIENT REPORTED PERSISTENT NECK MUSCLE STIFFNESS STARTING AROUND THE TIME THE FIRST DOSE OF SHINGRIX WAS GIVEN. HE REPORTED THIS TO THE PHARMACIST WHILE PICKING UP HIS SECOND DOSE.
Body pain; joint pain; Body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Body pain), ARTHRALGIA (joint pain) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain), ARTHRALGIA (joint pain) and MYALGIA (Body aches). At the time of the report, PAIN (Body pain), ARTHRALGIA (joint pain) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-032195 (Patient Link).
Swollen lymph gland by collar bone; Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, hypothyroidism (reported as low thyroid syndrome). The patient had no known allergies to medications, food, or other products. The patient had received other medication (unspecified) within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23March2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 20:00, the patient experienced swollen lymph gland by collar bone, body aches, fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swollen lymph gland by collar bone, body aches, fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
had my flu shot many weeks ago. Still I came down with the flue; Initial information was received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a non-health-care professional(Patient).  This case involves a patient of unknown demographics who had flu shot many weeks ago. still came down with the flue while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).      On an unknown date the patient developed a non-serious event of had my flu shot many weeks ago. still i came down with the flue (illness) (unknown latency) following the administration of influenza vaccine.  It was reported, " I had my flu shot many weeks ago. Still I came down with the flue. Missed Christmas day and still sick although feeling better."  No lab data was reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Recovering.
Administered PROQUAD vaccine and VARICELLA vaccines to same individual. Nurse thought she was administering MMR and VARICELLA separately but upon review, it was noted she administered MMRV in one arm and VARICELLA in the other.
1 of 5 pts ranging from 4-10 yrs who had inject site rxn (redness & swelling) & fever 102-104 w/in 24 hrs post vax, despite premedication w/APAP; pt had previous rxn to DTP & therefore was immunized w/DT;
Face swollen; Difficulty breathing; Fatigue; Hand swollen; Pain; Couldn't move arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045076) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced SWELLING FACE (Face swollen) and DYSPNOEA (Difficulty breathing). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Hand swollen), PAIN (Pain), MOVEMENT DISORDER (Couldn't move arm), SWELLING FACE (Face swollen), DYSPNOEA (Difficulty breathing) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Patient had a vasovagal response shortly after receiving the vaccine. Patient admits to having this reaction before with blood draws and other vaccines. Patient did not lose consciousness. Patient was given juice and crackers and a cool compress. He was observed for 30 minutes and then was comfortable going home.
Pt. reported being hot and dizzy.  No trouble breathing or any pain.  Pt. states she forgot to take her atenolol last night, but took it at 0300.  Pt. has a history of anxiety and didn't have breakfast.  Given a snack and reported feeling better, denies being warm and dizzy.  Released by physician at 11:25 and instructed to go to ED if worsened symptoms.  Pt. verbalized understanding.
PERIPHERAL NEUROPATHY 12/21/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Headache, arm and shoulder pain- 06/24/21 4pm Fever, chills, body aches- 06/24/21 11pm Lumps under right underarm- 06/26/21 8am Lumps under left underarm - 06/28/21 8am
13 yo received HPV #1, then hep A; within 1 minute c/o headache, then head drooped (placed supine) looked glassy-eyed to RN, extended (L) arm x 1. Responsiveness pale but all VSS = Syncopal episode
Left leg ant thigh erythematous about 10 cm, not indurated. No nodal involvement
INCREASED HEART RATE; DIZZINESS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 28 year old female. 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced increased heart rate. On 08-APR-2021, the subject experienced dizziness. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, and increased heart rate, and had not recovered from fever, and fatigue. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Pt was driving and was having a hard time swallowing, took some benadryl while waiting for husband then went to ER.  Ended up in ICU for 24 hours with severe reaction of throat swelling.
Around 2:30 in the morning, approx. 15 hours after the vaccination, I woke up extremely hot. I felt feverish, but did not check my temperature. I cycled between feeling hot and experiencing chills for an hour or two before I fell asleep again. When I woke in the morning, I felt normal again.
we got flu shots and after my shit I got the flu/ suspected vaccination failure; flu; got the Asian flu was so sick and it was terrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 81-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported but patient could be 80 or 81 years old. The patient stated that he/she never got flu shots years ago when just out of high school. The patient  got the Asian flu shot and was so sick and told that it was terrible. The patient was working in the hospital and got flu shots and after the shot he/she got the flu. The patient stated that they told it was not from the shot but he/she knew it was because of vaccine. The patient received the flu shots every year at age 81 and thought it was a good idea. The patient stated that If you do get the flu it would not be as bad he/she was hoping. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
patient was injected with 0.3ml of undiluted pfzier vaccine. no adverse reactions have been reported as of yet by the patient
Pain in right arm radiating down entire arm to fingers with tingling in arm at times. C/o 10/10 pain. Seen by Doctor on 16 Oct 2015 and treated symptomatically. No redness, no swelling at injection site. No fever.
Patient received vaccine that was expired; Patient is on a three dose regimen for the Trumenb/ Instead of getting two doses he will get three; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) on 24-Jul-2019.  This case involves patient of unknown demographics who was vaccinated with 0.5 ml dose of TRUMENBA (Batch number: S26985 and expiry date: 01-Jan-2019)  via intramuscular route in the left deltoid on 18-Jul-2019 and 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Batch number: U6220AA and expiry date: 31-May-2020)  via intramuscular route in the left deltoid on an unknown date.  The patient's past medical history included Myasthenia gravis.   It was a case of actual medication error due to expired vaccine used and extra dose administered.  It was unknown if any adverse event occurred or not following the vaccination.  No Lab data was reported.  The patient was treated with ECULIZUMAB (SOLIRIS) as a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
Malaise, headache, spinal pain resulting in hospitalization and spinal tap consistent with meningitis.