chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; started about 3 weeks after the first shot, headache; tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (started about 3 weeks after the first shot, headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (started about 3 weeks after the first shot, headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (started about 3 weeks after the first shot, headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Has not received her 2nd dose; Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In January 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). In January 2021, MATERNAL EXPOSURE DURING PREGNANCY (Was pregnant after she received the 1st dose/might have been pregnant when she received the 1st dose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) had resolved.        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.   Concomitant product use was not provided by the reporter.  The patient was still currently pregnant. She has 3 possible due dates were 11 Oct 2021, 18 Oct 2021 and 19 Oct 2021. The patient do not have information on her last period since she was on birth control, she did not have period.   Treatment information was not provided.  This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy and product dose omission issue with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
p/ pt recv vax 6/26 pt exp red, swollen lump lasting ``a couple of hours''. on 7/8 pt exp redness & tenderness at inject site
Generalized rash legs and arms. Red,warm facial cheeks under mask. Mild bronchospasm better with albuterol. Resolved in 3 hours
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
1. Inability to sleep after doses of Xyrem. 2. Loss of Consciousness ×3.  3. Falls x3--injuries to RIGHT arm, and lower back. 4. Confusion  5. Loss of Time Awareness 6. Reduced breathing, alamingly, during sleep 7. Clamminess; cold extremities 8. Shortness of Breath Lasted approximately 12 hours into March 21, 2021.
Thursday 01/13/2022, tickle in throat. Friday 01/14/2021, feeling unwell head cold and dry cough. Sunday 01/16/2022, Dry cough that lingered for 6-7 weeks and got progressively better, tingle in throat that would not go away. Diagnosis on Sunday 01/16/2022 COVID positive. Self tested and received PCR negative went out of the country and was tested again to return to states. Crystallization that made her have vertigo for 3 days and went to the doctor with 10 days cough was gone.
Inflammation at injection site and patient complaint of 6/10 intensity of tongue tingling.  Given Benadryl 50 ml, vital signs taken w/no critical values.  No respiratory distress.  Monitored for 30 minutes. At 15 minutes, tongue tingling reported to be at 1/10 on the intensity scale and swelling in arm resolved.
Within the first day or  2 I had a lightheaded feeling which came and went approximately 2 times.  I also felt as if I had to catch my breath abruptly a few times. Within 2 weeks of receiving vaccine I noticed an increased ringing in my ears.  In addition I developed urinary urgency which led to ?near miss ?episodes:of incontinence which had not previously been apparent.
Extreme fatigue, severe sinus pressure, headache, ears hurt, loss of memory. Tried Ivermectin and it worked for 2 weeks, then I got sick again. Tried mucinex and resveratrol and it worked for 2 weeks, then I got sick again. Now I'm on singulair and it helps, but I get sick off and on.
Patient reports feeling "hot and fatigued" roughly 30 minutes post-vaccination. He states he is feeling mild dizziness but denies and other symptoms. Patient was given juice and observed sitting in wheelchair. Patient reports symptom improvement and walked out on his own
This spontaneous report as received from a pharmacy technician concerning a currently 4 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 24-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Patient reports that 2 days after 3rd Hepatitis B shot, she began to have intermittent low-grade fever (99.7-100) and frontal headaches.  Injection site is not red or swollen but continues to be warm to the touch 18 days post vaccination and headaches and fever continue.  Advised to consult her physician.
strange reaction to the Moderna COVID-19; Inflammation in different areas of her body; gluteal muscle twitching; gluteal muscle soreness; Entire left arm tight; Entire left arm sore; Entire left arm achy; Right leg tingling; Sore feet; Fatigue in her legs; Twitching in her legs; Weakness in her legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness) and LIMB DISCOMFORT (Entire left arm tight) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN & MINERAL, ASCORBIC ACID (VITAMIN C ACID) and VITAMIN D NOS.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 11-Feb-2021, the patient experienced VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs). At the time of the report, VACCINATION COMPLICATION (strange reaction to the Moderna COVID-19), INFLAMMATION (Inflammation in different areas of her body), MUSCLE TWITCHING (gluteal muscle twitching), MYALGIA (gluteal muscle soreness), LIMB DISCOMFORT (Entire left arm tight), PAIN IN EXTREMITY (Entire left arm sore), PAIN IN EXTREMITY (Entire left arm achy), PARAESTHESIA (Right leg tingling), PAIN IN EXTREMITY (Sore feet), LIMB DISCOMFORT (Fatigue in her legs), MUSCLE TWITCHING (Twitching in her legs) and MUSCULAR WEAKNESS (Weakness in her legs) outcome was unknown.            Reporter did not allow further contact
Swelling went up into right thigh area; Swelling in right knee area; Skin was tighter around knee; Couldn't bend right knee like before; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee), MOBILITY DECREASED (Couldn't bend right knee like before) and PERIPHERAL SWELLING (Swelling went up into right thigh area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011A21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (In 1978 patient had surgery of the right knee and then post-operation had infection in the area) in 1978 and Physical therapy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee) and MOBILITY DECREASED (Couldn't bend right knee like before). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling went up into right thigh area). In March 2021, JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee) and MOBILITY DECREASED (Couldn't bend right knee like before) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling went up into right thigh area) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-195800.
Information has been received from a physician concerning a 33 year old female student with Crohn's disease and post-traumatic stress disorder who on 3/14/03 and 4/11/03 was vaccinated with the first and second doses of varicella virus vaccine live, respectively. There was no concomitant therapy. The physician reported that, in 2003, after two doses of varicella virus vaccine live the patient did not seroconvert as confirmed by a negative titer. The physician also noted that the patient had no adverse reaction. Unspecified medical attention was sought. Subsequently, a third dose of varicella virus vaccine live was given and the patient was noted to have a positive titer. Additional information is not expected.
15SEP 9PM noticed hives in axilla&behind knees-w/in 24hrs,hives covered body&coalesced;began DPH;16SEP AM hives subsided by 230PM;18SEP95 recalls no activities/foods that were out of ordinary 15SEP;12SEP had numbing med for root c
Mild rash appeared on arm in vicinity of vaccines - 4 days later on 04/6/09 and 4/20 severe rash on face - 4/21 severe generalized indurated pink papular rash all over, fever - 4/23 improving.
Patient presented to Hospital emergency room on 5/10/2021  with shortness of breath and dizziness. He had tested for Covid on 5/9/2021 for a pre procedure for a pulmonary function test. It is stated that he feels slightly short of breath chronically at baseline. Patient also notes occasional dizziness. No other symptoms.
Red, swollen, hot at injection site. Area of 3" x 1.5" cellulitis on (R) deltoid. Inj. given 9/7 seen for cellulitis 9/29. Tx - antibx's.
Myocarditis-Severe fatigue and chest pain amd shortness of breath for 7 days beginning 3 hours after injection and occurred after any small physical exertion like taking out the trash or walking 2 blocks  (lingering moderate fatigue and some chest soreness still remains today ), migraine for 3 days beginning 2 days after injection, left upper arm pain (sore) for 3 days beginning 12 hours after injection, sporadic mild running nerve pain for 7 days beginning 2 min after injection (no pain during injection itself), cold chills for 3 days beginning 24 hours after injection.
Patient had been feeling short of breath for 1 month; the dyspnea is intermittent with no known triggers, better with sitting in an upright position, exacerbated by moving around or talking and has been progressive. He has also been feeling dizzy for 1 month; the dizziness is intermittent, triggered by standing up or sitting down, it makes him feel like he would fall down; the dizziness is nonprogressive and he has had to use a can during these dizzy episodes. He has never tested positive for COVID-19. He received the 2nd dose of Moderna COVID-19 vaccine 1 month ago, which coincided with the start of these symptoms. He has had a little bit of a cough for 1 week; the cough is productive with dark brown phlegm and not associated with chest pain/pleuritic chest pain. He has progressive paroxysmal nocturnal dyspnea for 1 month.
Dizziness, Myalgia, NauseaVomiting, Chills, lower back pain Narrative:
9-30-11 - flu shot given, 4 pm shortness of breath, positive fever, positive chills, went to ER positive bronchitis.
Stabbing pain in right ear on Saturday evening. Doctor thinks it sounds like shingles. No blisters. Pt is seeing doctor again on Wednesday, 12-12-07.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: EYE PAIN NEXT MORNING. THURSDAY MORNING EYE SWOLLEN SHUT. DOCTOR SUGGESTED BENADRYL AND MONITORING. PATIENT WILL MONITOR AND FOLLOW-UP WITH PHYSICIAN AND PHARMACY.
Indication for use in the case: Treatment of COVID-19; Indication for use in the case: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine" (unspecified if ongoing), notes: Primary series completed (dose 1 and 2) with covid-19 vaccine and manufacturer unknown. Concomitant medication(s) included: ADDERALL; ZOLOFT also which were other medication in 2 weeks product. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication for use in the case: Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-JUL-2013 the patient was vaccinated with first dose of GARDASIL (dose/frequency: 0.5 ml) intramuscularly. On 09-JUL-2014, the patient was vaccinated with second dose and on 15-SEP-2014, the patient was vaccinated with third dose of GARDASIL. No adverse effect reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
Patients 2nd Moderna dose was given on day 22 instead of day 28.
Patient received 2nd Pfizer dose at 10:00 am.  She left the facility after 15 minute wait time.  Within the next 5 - 10 minutes she became SOB with respirations 40 per minute.  She was taken to Medical Center and seen by 10:45 - 11:00 am.  She was treated for anaphylaxis and was worked up for any other underlying problems.  She had to be put on the vent due to acute respiratory failure.   She was negative for COVID, pulmonary emboli and pneumonia.  As her status declined, ED felt she needed higher acuity care.  She was over the weight limit to be airlifted so she was transported by critical care ambulance to hospital where she is in ICU and on ventilator.
Immediate nausea, sweats/chills, lost color in face, blurry vision (similar to fainting, but did not pass out), felt weak.  Pain at injection site.  Arm felt tingly and weak.  Stayed in chair, deep breathing, drank water and Gatorade, placed head between knees.  Stayed on site for approximately 25 min until symptoms decreased to normal.
patient complained of swelling, warmth  and red blotches that extended half way down her arm
Information has been received from a consumer concerning her daughter, a 15 year old patient with no pertinent medical history and no known drug allergies who on 07-APR-2009 was vaccinated with the first dose of GARDASIL  (lot# not provided). There was no concomitant medication. Subsequently, on 07-APR-2009 the patient started feeling hot, clammy, and had blurred vision, and "had to sit down". The patient did not actually faint. She did experience some pain at the injections site and on 09-APR-2009, she called her mother and told her that her glands were swollen. No lab diagnostic studies were performed. Additional information has been requested.
The pt's symptoms started after shot #5. The pt experienced flu like symptoms that had lasted for 5 weeks, joint pain from the waist down for approximately 2 weeks, and  fatigue that is ongoing.
Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, were considered as 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.
Patient RECEIVED HER MODERNA BOOSTER DOSE AT 8:38 AM.  AT APPROXIMATELY 8:45 SHE REPORTED TO MYSELF AND an RN THAT SHE HAD THROWN UP AND DID NOT FEEL GOOD.  WE HAD HER SIT ON A BENCH CLOSE TO US AND TAKE OFF HER MASK.  SHE SAID SHE WAS FEELING WORSE SO WE HAD HER LAY DOWN ON THE BENCH, JUST SHORTLY AFTER LAYING DOWN SHE BECAME NAUSATED AND SAT UP TO VOMIT.  SHE LAID BACK DOWN AND BECAME UNCONCIOUS.  SHE WOULD NOT WAKE TO VERBAL OR TACTILE STIMULI, WE  INSTRUCTED STAFF AT THE FACILITY TO CALL 911.  AT 8:56 AM HER BP WAS 76/61, 0.5 MG DOSE OF EPINEPHRINE WAS GIVEN.  AT 9:00 AM SHE STARTED TO WAKE UP AND VERBALIZE TO US.  STATING SHE FELT BAD AND WAS TIRED.  BP WAS 138/83 9:05 AM  EMTS ARRIVED BP WAS 135/82 PULSE 116.  EMTS SAT HER UP TO MOVE TO GURNEY AND SHE STARTED FEELING LIKE SHE WAS GOING TO BECOME UNCONCIOUS AGAIN.  WAS TRANSFERRED TO GURNEY, IV STARTED AND TRANSFERRED TO medical facility.
Pain to gums and teeth; Pain to gums and teeth; This spontaneous case from was received on 25-Jan-2021 from non-heath professional (consumer) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On the same day, a few hours after receiving Flucelvax Quadrivalent, the patient experienced pain in gums and teeth.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company Comment: A of an unreported age and gender developed toothache and gingival pain on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported events is unassessable.; Sender's Comments: A of an unreported age and gender developed toothache and gingival pain on the same day after vaccination with the suspect product, Flucelvax Quadrivalent. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information, causality for the reported events is unassessable.
Fast heartbeat, dizziness, sore arm, trouble lifting and pain, still have problem 2 weeks later
This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported for the reporter's mother. The patient had an allergic reaction to SHINGRIX. As per packaging, to discontinue the vaccine if experience allergic to any of the SHINGRIX ingredients. The reporter asked to provide this information so that he could move forward in relieving the discomfort the patient was experiencing.
4x6" wheel with erythema and induration. Below site of injection. Increased temp to touch.
Diffuse urticaria beginning 1/2 hr post vaccine administration treatment with corticosteroids, H1/H2 blockers - EPIPEN dispensed secondary tightness in chest.
Fever, full body stiffness, extreme fussiness, puking, pain. Lasted from evening of vaccination for a week.