chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 04 February 2014 from an investigator participating in a study. A 33-year-old male subject, with no reported medical history, was diagnosed with lapses of consciousness on 02 November 2013, after receiving the unknown dose of Purified Vero Rabies Vaccine - Serum Free on an unspecified date (lot number, site and route of administration were not reported). Concomitant medications were not reported. The subject was hospitalized for the diagnosis of lapses of consciousness on an unspecified date. Complementary investigations and corrective treatment were not reported. The event of lapses of consciousness was resolved on an unspecified date. According to the investigator, the event was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 21 February 2014. The event term lapses of consciousness was changed to seizure. The subject was diagnosed with seizure on 02 November 2013 i.e. 239 days after receiving the third dose of IMOVAX Rabies on 08 March 2013 (batch number, site and route of administration not reported). The subject had received a first dose of IMOVAX Rabies on 08 February 2013 (lot number not reported) and second dose on 15 February 2013. The subject had concomitant medications but the details were not reported. The subject was hospitalized on 02 November 2013. The diagnosed event seizure was resolved on 04 November 2013. The subject was discharged from the hospital on 04 November 2013. This study was unblinded on 26 September 2013. Follow up information received on 25 February 2014. The details of concomitant medication were reported as, Tramadol of dose 50mg orally from September 2013 for treating pain, and NORCO of dose 10/325 orally from 04 November 2013 to 30 November 2013 for treating pain. Follow up information received on 04 March 2014. The subject had medical history of back pain and depression. The subject had third suspect dose of study drug by intramuscular route at deltoid right side. The subject had experienced symptom headache on 02 November 2013. Subject fell and had a seizure lasting 2-3 minutes. Subject was brought into hospital, and admitted to ICU. Subject was discharged in stable condition. Treatment details include KEPPRA 500mg orally twice a day. The lab details include CAT scan and MRI were performed. The symptom headache was resolved on 02 November 2013.
Person received final shot of Covid vaccine by Moderna today at 11:05am, then experienced dizziness 5 minutes after. Her blood pressure was 191/92 with HR of 94 at 11:20 am, then retaken at 11:40AM with values of BP=163/77 and HR of 95. SHe also experienced rash at injection site and in chest/breasts.
unusual menstrual cycle that has lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging; unusual menstrual cycle that has lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging; This is a spontaneous report from a contactable consumer (patient herself). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 12:00 (Batch/Lot Number: ER 8729) as the 1st dose, single for COVID-19 immunization. The patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: ER8735) on an unspecified date in the left arm. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. The patient's medical history were not reported. The patient had no allergies to medications, food, or other products. There were no concomitant medications; the patient had not received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient experienced unusual menstrual cycle that had lasted more than 2 weeks thus far with extremely heavy bleeding/hemorrhaging. The reporter assessed the event as non-serious. The patient did not receive any treatment for the adverse event. The outcome of the event was unknown.
The very next day after the administration of the Tdap (Adecel)I woke up with a very sore, red, hot, swollen shoulder just at the injection site and approximately 6-8 inches around the site and a stiff neck on the right side. I used a cool compress at the site for the first 48 hrs and then went to the doctors to have it checked and they suggested i start using warm compresses now so that is what i am doing right now.Area is still very sore, red,hot and swellen and has a hard lump under the skin and I continue with a slight stiff neck on the right side
Dermatographias unresponsive to steroids now taking antihistamines hourly for symptom management
Developed sensation of lump in her throat and problems swallowing.  No shortness of breath, chest tightness, rash, dizziness or rash.  Symptoms resolved without treatment in about 17 minutes.  Declined transport to ER for observation.
Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/13/2006. Information has been received from a physician concerning a female patient "between the ages of 11 and 16 years old" who on an unspecified date was vaccinated with GARDASIL. Within 1 to 2 days after receiving GARDASIL, the patient developed a fever and headache (date unknown). At the time of this report, the outcome of the events were unknown. Additional information has been requested. Upon review of the file, WAES #0610USA01349 has been found to be a duplicate of WAES #0610USA03614. Therefore, WAES #0610USAUSA01349 is being deleted from our files on GARDASIL.
Headache, Diarrhea, Injection Site Soreness Narrative:  Other Relevant History:
Pt reports she Immediately felt pain with injection. 10 days later reported ongoing pain, bruising high on shoulder and decreased mobility. Referred to orthopedics and diagnosed with left shoulder bursitis following XRay and treated with Medrol Dose Pak and diclofenac due to vaccine entering subacromial space. No improvement with conservative management. 12/11/18 received Depomedrol injection with no improvement. MRI 1/15/19 diagnosed with left shoulder AC arthritis, adhesive capsulitis and partial tear supraspinatous tendon with tendinosis. small effusion subacromial subdeltoid bursa. Referred to orthopedic surgery for possible arthroscopic subacromial decompression and manipulation under anesthesia. She was seen 1/21/19  Assessment indicated mild left shoulder adhesive capsulitis with AC arthritis. Partial-thickness rotator cuff tear. Surgical and nonsurgical interventions were discussed and she received injection of the left AC joint with 1 cc of 1% lidocaine and 1 cc of 40 mg/cc Kenalog with significant relief of pain and improved motion. Will begin physical therapy but  may ultimately need surgery.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, unknown for INFLUENZA. FLUMIST (intranasal) started on 21-Oct-2015 for INFLUENZA. It was reported that the administration to asthmatic patient. The outcome of the event ADMINISTERED TO ASTHMATIC PATIENT is unknown. The report was considered to be non-serious. Corrected Reported 13-Nov-2015: Relation to patient added. Reporter information added.
Narrative: mild PERICARDITIS requiring hospitalization with elevated cardiac troponins and medication therapy. Pericarditis diagnosed following 2nd Pizer COVID-19 injection (given 4-03-2021)
Pt did not develop "protective titers" p/3 doses of Engerix-B vax; "plan to revaccinate" pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if the person contracts Hepatitis";
she experienced a minor headache; This is a spontaneous report from a non contactable consumer. This female consumer(Patient) reported that she received the 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE at single dose for COVID-19 Immunization on unknown date. Relevant history and concomitant drug was unknown. The patient received the first dose of BNT162B2 for COVID-19 Immunization on unknown date. After receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine, she experienced a minor headache. She wanted to know what medication she should take to treat the symptoms, if she should take Aleve, Ibuprofen or Aspirin. Outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
felt hot; weird feeling of standing inside the body leaning onto herself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: FLU (fibromyalgia). Concurrent medical conditions included Drug allergy (Thimerosal).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself). At the time of the report, FEELING HOT (felt hot) and FEELING ABNORMAL (weird feeling of standing inside the body leaning onto herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-090430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090430:dose 2
About 6 days after the shot: itching at injection site. 7 days after the shot: 2 in diameter swelling around injection site, raised, hard, warm, very itchy and sensitive.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD. No other concomitant medication were reported. It was reported that the patient received PROQUAD at an unspecified time in the past and developed Down's Syndrome (congenital anomaly) at an unspecified time in the past. Reporter stated that patient "was grown now" (no details provided). The outcome of Down's syndrome was unknown. No product quality complaint was involved. Causality assessment was not provided. Upon internal review, the event of Down's syndrome was considered to be a congenital anomaly. Additional information has been requested.
17 hours after injection - lasted about 45 minutes:  1) Severe vomiting - took two doses of Emetrol with no relief. 2) Explosive diarrhea - took two doses of Imodium and that worked eventually.
Last night my wife spike to temperature 102.1 and it seem like a long time afterwards; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (wife) was received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), 19Jan2021 at single dose for covid-19 immunisation. Medical history was none. There is quite a number of concomitant medications. patient received the Covid 19 vaccine at 1:30 on Tuesday afternoon, they have had no problems since then but last night (22Jan2021) patient spike to temperature 102.1 and it seemed like a long time afterwards that she, because there has been no problems up to that point and it had been over 70 hours since the shot, reporter asked if that was a normal reaction. Treatment for the event was Tylenol. The last outcome of the event was unknown.   Information about lot/batch number has been requested.
On supplemental O2, Decadron, Remdesivir (8/11/2021)
KNEE FELT LIKE HAD ALMOST NEEDED TO YANK IT TO MAKE IT FEEL REGULAR; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was athletic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 30-APR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2022, the patient experienced knee felt like had almost needed to yank it to make it feel regular. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knee felt like had almost needed to yank it to make it feel regular was not reported. This report was non-serious.
at 1:55PM S/S: Patient began complaining of itchy arms, they appeared red then blotchy patches, patient indicated she did not have any shortness of breathe and swelling of the throat Tx: administered  50 mg of Benadryl at 1:58PM at 2:12PM Patient developed a rash and hives, Tx: Patient was transported to Hospital driven by a co-worker with her personal prescription of epi with her
Patient requested 2nd booster, only wanted Janssen, said doctor recommended. Patient unwilling to get Moderna/Pfizer. Patient administered 2nd booster (3 total doses) Janssen. It had been 6 months since 1st Janssen booster. Patient notified that it is not recommended to give 2nd booster Janssen. It is only recommended to give Pfizer/Moderna for 2nd booster. The patient stated her physician recommended it. She is having no adverse effects.
Patient received 1st COVID vaccine 4/12/2021 at medical center.  Per ER report: 4/14/2021 patient was in bed with significant other and was noted to not be responding.  EMS was called.  Patient was found without a pulse and apneic.  CPR began, PEA converted to Vtach, received 8 total epi and 1.5gm lidocaine by EMS.  Down 50-55 minutes prior to ER.  In ER given 2 additional epi, 2 sodium bicarb, intubated and was PEA then asystole.  Pronounced deceased in ER.
Most Important: Left side of face became numb/had a tingly feeling for about two hours then returned to normal. No swelling, still could move face. Less Important: Diarrhea, chills, aches. Resolved within 12 hours.
Patient presented to clinic today for 1st Covid vaccine. After receiving vaccine, patient complaining of seeing "colored spots".  Patient brought to reclining chair from waiting room. Patient has multiple comorbidity's - please see list in CMR. Patient's aunt in room with patient.  0807: Patient c/o having a "heavy face". VS 159/98, 89, 96% on RA. Patient denies any issues with breathing. Per patient when she swallowed some water, she felt as if it was hard to get down.  Patient given 50 mg PO Benadryl (own supply).  0811: Patient stating that colored spots are now gone. VS: 169/95, 87, 98% on RA.   0817: VS 133/90, 96, 93%. Patient had small seizure in room; patient eyes rolled back, patient appeared to be non-responsive. Total time for seizure was approximately 30 seconds. After seizure, patient responsive and alert X3.
Lump at injection site. Went away day after injection came back today itching and large lump
On 6/4 patient (pt) reported to workplace clinic that he started experiencing shoulder pain approx. 2 weeks post injection. Pt stated he felt the vaccine was given to high in the arm and took a picture of where the vaccinator had placed his band-aid. If the vaccinator gave the vaccine at the site of band-aid vaccinator gave the vaccine to close to pts acromion process. On 6/10 pt. reported his pain is now extending down from his shoulder to his wrist. Nurse onsite informed pt. that he should see a physician.
rash, but only on her legs; This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash, but only on her legs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash, but only on her legs). At the time of the report, RASH (rash, but only on her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications were reported   This case was linked to MOD-2021-392143, MOD-2021-392096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received, Added reporter details and the document contains non significant information
Information has been received from a physician referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date in June 2015, the patient was administered the first dose of GARDASIL 9 (lot #, expiration date, dose and route were not provided) in the series of three. The second and the third doses (lot #, expiration date, dose and route were not provided) were administered on an unknown date in June 2016 and 13-JUL-2016, respectively (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Post menapausal bleeding, lasted a few weeks.  Skin rashes started on 06/11/2021 to present day - Saw Doctor.
Fever, chills, redness at injection site. Tylenol, rest, and ice to site.
Pt. started feeling nauseous without vomiting and looked really pale like he was going to vomit. Via mom, he did eat lunch earlier today, but has a hx of passing out at the site of blood.  (child was also very shaky and nervous during the 1st dose via mother)
Same reaction in arm; nausea; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Same reaction in arm), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Same reaction in arm), NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On 02-Mar-2021, NAUSEA (nausea), CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) had resolved. On 05-Mar-2021, VACCINATION SITE PAIN (Same reaction in arm) had resolved.            Treatment medication was not provided. Concomitant medication was not reported.   This case was linked to MOD-2021-035798 (Patient Link).
pt recv vax OCT98 & pt devel diabetes which was considered to be an important medical event;
Approximately 2 wks following vaccination of MMR, patient developed fever and pain and swelling in both knees.  She is using crutches to walk at present and waiting referral to orthopedic.
2nd dose of Menveo 5 weeks apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A) for prophylaxis.   Concomitant products included MENVEO.   On 10-AUG-2023, the patient received Menveo. On 10-AUG-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2nd dose of Menveo 5 weeks apart).     The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2023 An office manager called to inform that an 18-year-old patient that received the 1st dose of Menveo on 7th July 2023, received a second dose of Menveo on 10th August 2023 which led to extra dose administered. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
felt bad; Experienced flare up of the arm; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced feeling bad, rash over arms and incomplete course of vaccination. On an unknown date, the outcome of the feeling bad, rash over arms and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the feeling bad and rash over arms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient the patient experienced flare up of the arm and felt bad after first dose and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  The pharmacist unable to provide full patient details. The reporter did not consented to follow up.  This case was 1 of 8 cases, reported by same reporter.
MMR 12/21/06 one week later, pain, swelling. Describes - neuralgia with pain radiating distally has residual muscle defect at injection site. No medical intervention.
Abdominal pain; Vomiting bile; I went to the ER and was seen by Dr. (Privacy). I passed a kidney stone; raptured cyst in my kidney; Gall bladder inflammation; Gall bladder removal.
Seen in ER on 9/18/21 with acute dyspnea. Had a MVC about two weeks ago. He had a small pneumothorax. He did not need a chest tube. The patient was noted to have several rib fractures but stated he had been doing much better but had progressively become more short of breath. Patient was admitted with COVID Pneumonia and date of death was 9/20/21 following a cold blue and withdrawal of care by family.
To be transparent, the current issues may not a result of the vaccine. However, about 7 to 10 days after receiving it, my immune system became hyper-stimulated. I am currently having  flare up of my hidradenitis suppurativa, which has been in remission for years. I needed to have a prescription for Zofran due to almost constant nausea that went on for days. My fatigue and general body pains are intense, and I am barely able to participate in my normal life functions. In addition, I developed a 5.7 cm nodule on my Thyroid about 3 weeks after receiving the vaccine that was not present before.
lethargy, fever, chills, headache, fatigue up to 6 days post vaccination.
All symptoms aligned with the reported Heart Inflammation reactions. Primary symptom showed as  shortness of breath and noticeable heart "flutter"/pounding and heart rate spikes. that began a week or so after the 1st vaccination.  The Emergency room was visited soon after these symptoms began but tests came back inconclusive. Symptoms gradually improved over 1-2 weeks but returned more significantly after the 2nd vaccination shot. These symptoms lasted for about a month.