chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (she had become immunocompromised) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product RITUXIMAB (RITUXAN) for an unknown indication. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Dec-2021, the patient started RITUXIMAB (RITUXAN) (unknown route) at an unspecified dose. On 15-Dec-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNODEFICIENCY (she had become immunocompromised) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (she had become immunocompromised) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNODEFICIENCY (she had become immunocompromised) to be not related. No concomitant medication was reported. Patient's doctor recommended that she get a 4th full dose dose. Patient advised Pharmacist that she had become immunocompromised after taking Rituxan. Patient started taking Rituxan on 15 Dec 2021 but Pharmacist did not know the reason. Pharmacist asked if he should he give patient the 4th dose or not. Lot number and Patient's demographics were not provided. No treatment information was reported. Company comment: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious event of Immunodeficiency (seriousness criteria medically significant) which occurred 1 month after the third dose (booster dose) of mRNA- 1273 Vaccine. It was reported that patient had become immunocompromised after taking Rituxan the co-suspect product. The co-suspect product of Rituxan could remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-513412 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2022: Follow up report include no new information. On 16-Mar-2022: Follow up report include no new information. Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious event of Immunodeficiency (seriousness criteria medically significant) which occurred 1 month after the third dose (booster dose) of mRNA- 1273 Vaccine. It was reported that patient had become immunocompromised after taking Rituxan the co-suspect product. The co-suspect product of Rituxan could remain a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever of 101, today her fever, it went down later in the evening, today her fever was at 99; This is a spontaneous report from a contactable consumer (patient's brother). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever of 101, today her fever, it went down later in the evening, today her fever was at 99. It was reported that she got her vaccination on Saturday. Sunday, she had a fever of 101, today her fever, it went down later in the evening, today her fever was 99. The patient underwent lab tests and procedures which included body temperature: 101 and 99. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax 2PM-3PM 25APR96-pt presented in good hlth-sl cough but chest clear to auscultation-mom stated no fever in last 48hr;this was pt 1st immun w/no adverse changes noted in clinic;mom states pt fine&put to bed-found dead in bed
client developed hives and increasing redness on both forearms.  25mg po Benadryl was given post vaccination at 2:45 pm.  Symptoms resolved and client left post vaccination monitoring area at 3:30 pm.
With each dose of Moderna approximately 24 hours after receiving it, I had an erratic heartbeat (racing heart) for about 8 hours. I did not have trouble breathing. I have high blood pressure, but it is completely controlled via medication.
No additional AE; Patient was inadvertently administered an expired dose of ROTATEQ; This spontaneous report has been received from a registered nurse concerning a 7 months-old male patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.         On 15-DEC-2020, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 ml, Lot # S017630, expiration date 06-DEC-2020 for prophylaxis (dosage regimen was not reported).  The administered dose did not experience any temperature excursion and no additional adverse events were reported.
Moderna COVID-19 Vaccine  Approximately 7 days after I received dose 1, I started having symptoms at the injection spot.  This included inflammation, a bright red rash, and pain to the touch.
Swollen warm red and itchy at injection site. He was advised to take ibuprofen and Benadryl and apply ice for 20 minute intervals. He was advised to call us or see his primary care physician if it worsened.
This spontaneous report was received from a medical assistant refers to multiple patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II, lot # reported as L009219, expiration date 17-MAR-2017; lot # reported as L020189, expiration date 03-JUN-2017 (strength, dose, route of administration and albumin status were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Initial case received from a consumer who is the patients' parent on 02 July 2013. It represents three unidentified female patients of a cluster of four patients reported by the same reporter who each experienced an adverse reaction following administration of IMOVAX RABIES and HRIG (manufacturer unknown). The events for the other patient are captured in case number 2013-07502. On an unspecified date in 1998 the patients were administered IMOVAX RABIES (batch number not reported) and HRIG, manufacturer unknown, dose, route and sites not reported. Concomitant medications and preexisting medical conditions were reported as unknown. It is unknown if the patients received other vaccinations within 4 weeks of vaccination. On a unspecified date in 1998 the patients experienced "Universal reactions to most substances" which has been worsening since 1998 and it is described as being "at it's height now". One unspecified daughter can only eat 10 substances. Another sleeps on the floor with a mask filter on. One has thyroid failure, one has seizures and one has migraine heads. The patients required an ER/doctor visit on an unspecified date for an unspecified duration. The reporter refused to give her physician's name or any other information. The patients outcomes are not recovered. Documents held by sender: None.
I start feeling a lump in my vaccinated arm with swelling and redness about April 15. 2021
severe aches and pains, severe chills and fever of 102 that started 11 hours after the shot.  Lasted through the night and the next day.  started to feel less symptoms day 2 and now on day 3 and still have mild symptoms...no fever.
BABY VOMITED X 2. DID NOT ACT SICK. NO TEMPERATURE. BABY SLEPT WELL THE NIGHT BEFORE AND ATE MEAL IN EVENING.  MOTHER GAVE MOTRIN FOR DISCOMFORT THE PREVIOUS NIGHT.  NO FURTHER TREATMENT.  MOM ASKED IF SHE WOULD LIKE THIS REPORTED AND SHE SAID YES.
Vaccine site red, slightly swollen, hot to touch. Treated with KEFLEX, site marked. Pt advised to RTC tomorrow for follow up.
This spontaneous report has been received from a licensed practical nurse referring to a 17 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided) and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
Arm soreness began and continues to present date of 10/13/13. Unable to lift arm over head or carry over 5lbs. Sharp pain and burning at injection site. Pain radiating down arm to fingertips.
patient said she developed tinnutis after getting the shingrix vaccine. She called Friday 8/28 to let me know, then on Sunday 8/30, she said she lost hearing in that ear.
Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.
At 2AM (~40hours after vaccine) awoke with chills and drenched in a cold sweat. Also facial tingling, swollen lips, and red splotchy skin.
My arm became very sore and swollen at the injection site and the following day the rt. side of my neck felt like I had slept wrong Like I had a (crick) this  progressed down across my chest to the left side even though the rt. side became somewhat less painful. To this day a week later I now have crick in the left side of my neck and into my shoulder. The right side is better now. I did not go to Dr. just felt it would resolve soon.
Stomach bleed from blood thinners; Tested positive for COVID-19; A spontaneous report was received from a consumer concerning a 91-year-old, White, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a positive Covid-19 test and the serious adverse event of stomach bleed from blood thinners.    The patient's medical history, as provided by the reporter, included dialysis three times a week with a port in his left arm, broken hip, and stomach bleed. No medication allergies reported. Concomitant medications reported included acetylsalicylic acid and multiple medications not otherwise specified.    On an unknown date prior to receiving the vaccine, the patient began to experience stomach bleed. He was hospitalized and discharged before the vaccination.  On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after the injection, the patient was tested for Covid-19, and the results were positive.   On an undisclosed date purported to be two weeks after vaccination, the patient was hospitalized due to a stomach bleed from blood thinners, and an unknown blood vessel procedure was performed.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, tested positive for Covid-19 and stomach bleed from blood thinners, was not reported.; Reporter's Comments: A spontaneous report concerns a 91-year-old, White, male, patient, with medical history of dialysis three times a week with a port in his left arm, broken hip, and stomach bleed, who experienced a positive Covid-19 test and the serious event of stomach bleed from blood thinners. The event of positive Covid-19 test occurred on the same day after the administration of the first dose of mRNA-1273 (Lot number 025J20A, expiration date 29 Jun 2021) and stomach bleed occurred on an unknown date after the vaccine administration. Treatment for stomach bleed included blood vessel procedure. Based on the information provided, there is not a definite association between the vaccine administration and the reported events. Use of blood thinners could have contributed to the event of Stomach bleed, also confounded by the patient's medical history of stomach bleed and concomitant use of acetylsalicylic acid. COVID positive test was obtained on the same day as vaccination and unlikely to have resulted from mRNA-1273 administration.
Patient received influenza vaccine intramuscularly in her left arm. She complained on one year later that she had been experiencing ongoing pain and weakness in her left arm since the vaccination. She continued to receive occupational therapy for this and prior back pain.
Patient felt nauseous after vaccination and vomited x 1 in bathroom with RN present. She stated that she felt better afterwards. Vital signs stable. Evaluated by an MD on site and discharged from clinic.
Information has been received from a licensed practical nurse who was splashed with MMR; a single drop of fluid from the needle splashed her in the eye after she had injected another patient. On 20-MAR-2007, the patient experienced irritation with some redness in her eye. It was noted that the patient being vaccinated at the time received the full dose. Unspecified medical attention was sought. She flushed her eye with water. The outcome was reported as recovering. No further information available. There was no product quality complaint. Additional information has been requested.
Extreme fatigue, muscle and joint pain stiffness, chills, 102F fever.
Round red fairly large circle around injection site on arm that appeared many days after I got the vaccine. Slightly warm to the touch but not painful. Not going away after several days.
10 days after vaccinations (9/19) he started experiencing a new headache and sensitivity to light along with nausea. He went to emergency room and was treated for migraine. His headache continued and on 9/27 (18 days after vaccinations) he went to primary care MD who ordered MRI of brain with and without contrast as well as CT angiogram of brain. Imaging showed no significant abnormalities. On 10/6/22 (27 days after vaccinations) he went to emergency room again for same symptoms as well as left arm numbness and memory issues as well as worsening drowsiness. CT angiography was normal and he was discharged. On 10/11/2022 (32 days after vaccinations) he become significantly more confused and sister insisted he go to emergency room again. Repeat MRI brain showed significant bilateral (right > left) medial temporal enhancing lesions. Workup negative for infections and serologic autoimmune/paraneoplastic disease. He did not get any steroids or treatments aside from very briefly being on acyclovir for initial concern for HSV encephalitis.   Subsequent imaging as shown improvement in brain lesions but discovered a cervical spine lesion (unknown if this was present before. FDG PET showed small area of avidity in thoracic spine so now getting thoracic spine MRI.   He is slowly improving in terms of his cognition and left-sided weakness. He has high cognitive reserve so is able to function despite slowly recovering encephalopathy.
PATIENT NORMALLY STEADY ON FEET, FELL HIT HIS HEAD, HAD SLURRED SPEECH, SEEN IN EMERGENCY ROOM HAD CAT SCAN OF HEAD WITH NO INTRACRANIAL ABNORMALITIES NOTED, RETURN TO SKILLED NURSING FACILITY AND PASSED AWAY SAME DAY
Rosy Cheeks; puffy face; throat was irritated; uncomfortable to swallow; sore throat; This case was reported by a consumer via call center representative and described the occurrence of rosacea in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2022, the patient received the 2nd dose of Shingrix. On 17th March 2022, 2 days after receiving Shingrix, the patient experienced rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat. On an unknown date, the outcome of the rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the rosacea, facial puffiness, throat irritation, swallowing difficult and sore throat to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received her second dose of Shingrix vaccine in left arm and one day before reporting she had rosy cheeks, a puffy face, and her throat was irritated (sore throat, uncomfortable to swallow).   On the day of reporting, the patient stated that her symptoms were better, but had not subsided.   The patient was advised to follow up with health care professional (HCP). The patient gave consent to follow up with HCP (pharmacy). The patient provided limited information. The reporter consented to follow up.
The day after getting my booster (after the Benadryl wore off) I started getting hives and itching. Allegra was able to stop it for a while. Gone by day 3.
parent called & stated pt had rash, fever to 102 & diarrhea x 3 days;(started 7 days post vax);pt seen by MD 6NOV96 MD states rxn to MMR vax;
COVID-19; congestion; sore throat; heart palpitation; could barely move the arm of injection; aches; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (congestion), OROPHARYNGEAL PAIN (sore throat), PALPITATIONS (heart palpitation) and MOBILITY DECREASED (could barely move the arm of injection) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVETIRACETAM (KEPPRA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced NASAL CONGESTION (congestion), OROPHARYNGEAL PAIN (sore throat), PALPITATIONS (heart palpitation), MOBILITY DECREASED (could barely move the arm of injection), PAIN (aches), CHILLS (chills) and FATIGUE (fatigue). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of UNK dosage form. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (congestion), OROPHARYNGEAL PAIN (sore throat), PALPITATIONS (heart palpitation), MOBILITY DECREASED (could barely move the arm of injection), PAIN (aches), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications were depression medicine and migraine medicine. Other treatment medications taken were  inhaler and a medicine for cough.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 22-DEC-2015 the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K007243, expiration date 13-DEC-2015; dose and dose number were not reported; oral). No adverse effect was reported. This is one of several reported received from the same reporter. Additional information has been requested.
had not received dose three.; received the first dose of Twinrix in September 2019, the second dose on 08-Oct-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in September 2019).   On 8th October 2020, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 8th October 2020, an unknown time after receiving Twinrix, Twinrix and Twinrix Pre-Filled Syringe Device and unknown after starting Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pharmacist intern. The age at vaccination was not reported for 2nd dose and it was not applicable for 3rd dose. The patient was vaccinated with 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Just after injection, her vision was filled with cloudy brown stuff and then she fainted. Prior to the shot, she felt normal and not visibly nervous.