chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On March 20th had headache and dizziness. Had problem walking. On the 21st he turned pale and felt ill. On the 22nd he couldn?t walk or speak. Lost control of his bladder. Had extreme dizziness and headache. Sobbed uncontrollably.  Took patient to primary for evaluation. They sent him bu ambulance to Emergency.
menstrual bleeding 2 days after being administered the vaccine (menstrual cycle was not supposed to begin until the next week). bleeding was accompanied by cramping as well as hot flashes.
May 14 Low fever (100.4 at highest measure), chills, headache - lasted about 8 hours, treated with Tylenol and sleep Joint aches - in random places on body, but worst in left knee (moderate - severe pain when standing with weight on left leg) Fatigue  May 15 High temp but not fever (99.8 or so) - slight feverish feeling Fatigue Pain on sides of ribcage about midway down, accompanied by tightness in chest and upper back, pain between left shoulder blade and spine, pain on right side of esophagus (?), pain in right jaw, heart rhythm felt normal speed but very hard - this all went away on its own after 1 - 1.5 hours Sharp pains in random places on body Tingling in feet and hands that came and went (mainly left hand, right foot) Nightmares
Redness, swelling, started within two days after dose was given. Loratadine and Ibuprofen.
Redness around injection area, slight tenderness and itchyness. Arm feels a bit sore
SUSPECT CLINICAL VACCINATION FAILURE; SUSPECT COVID-19 INFECTION; This spontaneous report received from a patient concerned a 73 year old male.  Initial information was processed along with additional information on 06-MAY-2021.  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) 0.5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-APR-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. The patient was so sick for 7 days and no fever. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection and was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178616.; Sender's Comments: V0: 20210509524-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Rash after vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient experienced rash after Shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact details were available.
Pt received first dose of Engerix-B in rt arm and noticed numbness and tingling in the 4th and 5th fingers of the rt hand and under the rt arm between the shoulder and the elbow. Follow up #1 symptoms of back pain associated w/brachiopathy.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Medium, Additional Details: PT PRESENTS WITH A DARK ALMOST BLACK BRUISE RIGHT NOW AT INJECTION SITE. WAS TREATED WITH PREDNISONE AND NAUSEA MEDS. HAD FINISHED PFIZER BEFORE BUT SWITCHED TO MODERNA FOR THE BOOSTER DOSE.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (he could not sleep because of the pain in his left arm) and vaccination site pain (injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 003A21A) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 15, 2021, patient experienced pain in extremity (he could not sleep because of the pain in his left arm) and vaccination site pain (injection site pain). At the time of the report, pain in extremity (he could not sleep because of the pain in his left arm) and vaccination site pain (injection site pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Woke up at 7am the next morning w/ a 101.6 fever.  Ran a temperature off and on all day and slept all day.  No fever the next day but still napped - very unusual behavior for her.  Okay by following day.
This spontaneous report was received from a Registered Nurse, referring to an unknown number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were vaccinated on unspecified dates with improperly stored doses of GARDASIL 9, (lot # M028323 expiration date: 26-SEP-2018). No adverse effect reported. No further information was received. Temperature excursion: 35.2 degree F for 1 hour and 6 minutes. This is one of two reports received from same reporter.  Additional information has been requested.
slight arm discomfort; I only ran a fever of 100.6 for 6 hours; 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months; This case was reported through a regulatory authority by a registered user and has provided consent for follow-up contact. You may send follow-up letter at:  ******************* START OF PRODUCT TAB ********************** -----------------START OF Moderna Vaccine---------------------------------  ##Vaccine Dose Number in Series (Vaccine use only) :Second Dose ##Site of administration :Right Arm ##Will additional vaccine be administered? (For Vaccine Use Only) :Unknown -------------------END OF Moderna Vaccine--------------------------------- ******************* END OF PRODUCT TAB ********************** ******************* START OF EVENT TAB ********************** -----------------START OF 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months---------------------------------  ##Describe the side effect in more detail and if any treatment was needed: Cannot take NSAIDS but I take Tylenol and on some days Vicodin as the pain is so constant and severe I can't  sleep or get ant relief. The entire large muscle aches and goes up into my R shoulder . NEVER had ANY problems until I got the COVID Vaccine. I only ran a fever of 100.6 for 6 hours with slight arm discomfort after #2 which was controlled with Tylenol. ##Was the side effect serious?: Unknown -------------------END OF 2nd Vacc developed severe ache in R lg musc.Went to R shoulder.Constant & need meds after3 months--------------------------------- ******************* END OF EVENT TAB ********************** *******************START OF  Patient ******************** ##What is the gender of the person experiencing the side effect?: Female ##Was or are they pregnant?: No ##Please provide results of tests/labs, medical history, allergies, etc. Do not provide any patient identifiable information (e.g. name, DOB) in this box:: Healthy, active female allergic to Morphine, Diladid, Tordol, Haldol, Tetanus   ********************END OF  Patient ********************
Pt recvd 3 doses of Engerix-B vax & 1OCT91 found to be a non-seroconverter;
Initial event (the evening after) stomach pains/cramps, next day slight dizziness like a cold was coming on.  Redness and swelling at the injection sight remained and began to get larger, redder, and more uncomfortable seven days after. Area continuing to grow in size on day 9 (today)
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 14-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 348 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the database. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
LOST THE TASTE; LOST ALL THE FEELINGS IN THE RIGHT FOOT AND IT IS GOING UP HIS LEG; AMBER BURN THROUGH THE TOP OF THE SHOE AND WENT IN BETWEEN HIS BIG TOE AND HE NEVER FELT IT; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient stated that he does not take any medications or anything else and was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced lost the taste, lost all the feelings in the right foot and it is going up his leg, and amber burn through the top of the shoe and went in between his big toe and he never felt it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost the taste, had not recovered from lost all the feelings in the right foot and it is going up his leg, and the outcome of amber burn through the top of the shoe and went in between his big toe and he never felt it was not reported. This report was non-serious. This report was associated with product quality complaint: 90000291079. The suspected product quality complaint has been confirmed to this customer preference case had been assessed and does not represent a product quality complaint or product performance issue based on the PQC evaluation/investigation performed.    .  .
Pt recvd 1 dose of Engerix-B & devel localized erythema, vomiting & a rash; this resolved p/24 hrs;
2/5/2021  Tachycardia up to 180 @ home w/ chest pressure about 24 hours following 2nd vaccine dose. Went to ER.  Tachycardia resolved with IV fluids in ER. 2/7/2021  Tachycardia @ 162 @ home.  Went to ER.
I26.99 ACUTE PULMONARY EMBOLISM 4/16/2023 UTI (URINARY TRACT INFECTION) I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/16/2023 UTI (URINARY TRACT INFECTION)
1. Shaking 2. Whole body tingling  3. Left arm tense (injection was provided in right arm) 4. Felt clammy  Walked over to hospital attached to the facility and was discharged the same day. All symptoms resolved.
Pt recvd a series 3 Engerix-B 29OCT90, 21NOV90 & 7MAY91 & was a non-responder;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) in a 56-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion) 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 medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the local Health Authority at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients
Within hours of getting the booster shot, and only 10 days after my last period which is usually very regular, I started a very heavy period that lasted 6 days with an extremely heavy flow and thin, bright red blood - not the usual flow. After 30+ years of having a period, I've seen a lot of variety but this was unlike anything else I've experienced - it could not be contained by any of the usual methods, and it didn't stop for days. I also experienced extreme fatigue and slept 20 out of 24 hours the day after, though I don't know if it was related to the flow or the vaccine.
high fever; vomiting,; sweating; cramps on both hands; couldn't move her hands; This is a spontaneous report from a contactable consumer (husband) from a Pfizer Sponsored Program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 08Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer OVID19 vaccine on 08Apr2021. According to (Name), the patient had some high fever, vomiting, lots of sweating and cramps on both hands this morning (09Apr2021) around 3 am, couldn't move her hands and she couldn't move her hands. Outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Felt "woozy", sees "white spots," sees "waves" "like heat on a dessert." States " shot was exceptionally painful" "found herself on the floor. Patient feels better after lying down, drinking gingerale, eating crackers. Had loss of consciousness - refused ER.
Rash all over his body; still itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over his body) and RASH PRURITIC (still itchy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN (LIPTOR [ATORVASTATIN]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced RASH (Rash all over his body) and RASH PRURITIC (still itchy). The patient was treated with PREDNISOLONE (oral) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash all over his body) and RASH PRURITIC (still itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated that on 21-Jan-2014, the patient was inadvertently administered FLUMIST QUADRIVALENT which expired on 20-Jan-2014 and also stated that no other details are available. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by reporter.
Injection site was swollen, size like a mosquito bite; Rash local to the injection site; Itching at injection site; A spontaneous report was received from a healthcare professional concerning a 41-year-old female patient who experienced itching at the injection site, injection site swelling and rash local to the injection site.  The patient's medical history was not provided. The patient is not currently taking any medications.   On an unknown date, approximately 7 days prior to the onset of symptoms, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly in her left upper arm for prophylaxis of COVID-19 infection.   On 04 Jan 2021 approximately 7 days after receiving the vaccine, the patient started having itching at the injection site. The injection site swollen and appears to be the size of a mosquito bite. She also had a rash that was local to the injection site and occasionally itches.   The patient has not received any treatment for the events.    Action taken with mRNA-1273 in response to the events was not provided.   The outcomes of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Myalgia, Arthralgia, Severe pain right cheek, pressure behind right eye Narrative:
headache  hard to move pt felt like she was drunk  dizzy between her toes and ankles she had pain like her bones were broken  swollen legs
LOCAL TITLE: EMERGENCY                                           STANDARD TITLE: EMERGENCY MEDICINE NOTE                          DATE OF NOTE: JAN 10, 2022@12:48     ENTRY DATE: JAN 10, 2022@12:48:06                                  URGENCY:                            STATUS: COMPLETED                          *** EMERGENCY Has ADDENDA ***  ER Triage Note Patient is a 79 year old FEMALE presents to Emergency Department on 01/10/22 12:18.       Tetanus status: Last Tdap: Mar 14, 2012      LMP:  NA - menopausal    Chief Complaint: Visit CC: HA, DIARRHEA, BODYACHES, CHEST TIGHTNESS +   COVID.   LOCAL TITLE: RN NOTE                                         STANDARD TITLE: RN INPATIENT NOTE                                DATE OF NOTE: JAN 10, 2022@18:45     ENTRY DATE: JAN 10, 2022@19:12:11                                       URGENCY:                            STATUS: COMPLETED                       PT ARRIVED FROM ED. PT ORIENTED TO ROOM, EDUCATED PT ON COVID VISITOR POLICY. PT  FOUND AT 90% ON RA. PLACED PT ON 2L NC. PLACED PT ONTO BEDSIDE MONITOR. PT SEEN  AMBULATING FROM BATHROOM, STEADY ON FEET. PT WITH UNA BOOT INTACT TO R LOWER LEG.  PT STATES DRESSING APPLIED TODAY IN WOUND CARE. PT ALERT AND ORIENTED. Patient is a 79 year old FEMALE currently was admitted on 01/10/22 16:05  Patient is being discharged from HOSPITAL Family  Care Unit today JAN 15, 2022
getting sick; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient received both injection of suspect vaccine and she got sick after the second injection. The patient reported having antibody testing done afterwards that showed negative for IgM antibodies and positive for IgG antibodies. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 46 yr old white female with foot pain, pruritus and an allergy to erythromycin who on 11Jan05 at 10:00AM was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). Subsequently, the pt developed whole left arm redness, bruised and hot touch. The pt recovered. Unspecified medical attention was sought. Additional information has been requested.
Influenza B; patient received the Fluzone Quadrivalent and was admitted with flu; Initial information received on 22-Jan-2020 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 14 year old female patient who experienced influenza B (influenza) and vaccination failure (vaccination failure), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.   On 30-Oct-2019, the patient received a 0.5mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6686MA, of Expiration date: 30-JUN-2020) via intramuscular route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a serious influenza B (influenza) and vaccination failure (vaccination failure) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. The diagnosis of was made on 15-Jan-2020. The patient spent three days in the ICU before being discharged.  It was reported that the patient received the Fluzone Quadrivalent and was admitted with flu (vaccination failure).  (Other relevant tests included no lab data.)  Final diagnosis was vaccination failure and influenza .   An unspecified corrective treatment of 3 days in the ICU unit was received.  On an unknown date, the patient had recovered from the events.; Sender's Comments: This case concerns a 14 year old female who presented with influenza and vaccination failure after the administration of FLUZONE QUADRIVALENT. The time to onset is compatible. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed