chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red itchy bump on the right arm  after second shot of vaccination; red itchy bump on the right arm  after second shot of vaccination; red itchy bump on the right arm  after second shot of vaccination; feeling tired after the second vaccine; light-headed after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light-headed after the second vaccine), VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination) and FATIGUE (feeling tired after the second vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019821A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (light-headed after the second vaccine) and FATIGUE (feeling tired after the second vaccine). On 10-Apr-2021, the patient experienced VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination) and VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination). At the time of the report, DIZZINESS (light-headed after the second vaccine), VACCINATION SITE MASS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE PRURITUS (red itchy bump on the right arm  after second shot of vaccination), VACCINATION SITE ERYTHEMA (red itchy bump on the right arm  after second shot of vaccination) and FATIGUE (feeling tired after the second vaccine) had not resolved. Not Provided           Patient also reported that will be having a HIDA scan to check her liver and other parts on Thursday 15Apr2021 if doesn't affect her vaccine. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 06/19/2022 and it was a rapid test done an urgent care center. I had a cough, nasal drainage and I lost my voice. No fever and no other symptoms. I did not take anything for my symptoms prior to being seen at the urgent care center. They did write a prescription for Paxlovid. I did start feeling better until 4 or 5 days after starting the medicine. I continue to have the cough as of today.
13 mins after injection. Felt like a rubber band snapped my forehead. Eyes lids instantly became extremely heavy and blurred followed by some  dizziness.  Did not mention this to anyone at the time. Drove home. Experienced headache, extreme fatigue , chills, and extreme lethargy.  This lasted for a few days but at least a week or so before all symptoms abated.
Subject, a 28 year old male with a history of 5 previous dosings of the Anthrax vaccine developed headache pressure behind the eyes and was described as having no energy on 01/5/00 after receiving an Anthrax vaccination (lot FAV048B) on the same day. No other vaccinations were administered with this dosing and no concomitant medications or treatment were noted. The pt was said to be recovered from this event. Additional information will be provided, as it becomes available. Reported on: 08Feb01.
Patient was very nervous about getting the covid Janssen vaccine and worked himself into an anxious state prior to getting injected.  Very soon after getting injected, possibly 5 minutes, he passed out while sitting upright in a chair in the pharmacy.  He quickly, possibly 10 seconds, regained consciousness, at which point we called for EMS.  He was given water, but soon after, possibly 5 minutes, he passed out again.  This time I noticed he was very sweaty and red in the face.  He regained consciousness easily as before, but I insisted he lay down on the floor this time.  With the help of a couple other people, I lowered him gently to the floor, putting a sweatshirt under his head, and feet up on a chair, to raise above his heart.  His color quickly returned to normal and he seemed very alert at this point.  EMS arrived, they evaluated him, and determined he was fine.  After about 15 minutes, he sat back into the chair, drank water, waited another 20 or so minutes, then chose to drive home.  I requested he call when he got home, he did, without any further incident.
cold sores flared up on lips; Nausea; Fever; Intense pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Intense pain), ORAL HERPES (cold sores flared up on lips), NAUSEA (Nausea) and PYREXIA (Fever) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Intense pain), NAUSEA (Nausea) and PYREXIA (Fever). On 21-Mar-2021, the patient experienced ORAL HERPES (cold sores flared up on lips). At the time of the report, PAIN (Intense pain), ORAL HERPES (cold sores flared up on lips), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Pt developed diffuse itchy hives across back and along arms. Recommended pt to use BENADRYL and seek emergency help if symptoms worsen.
very sore left side started in left jaw under ear, down to neck to top of shoulder/shooting pain from jaw to elbow; very sore left side started in left jaw under ear, down to neck to top of shoulder/shooting pain from jaw to elbow; very sore left side started in left jaw under ear, down to neck to top of shoulder/shooting pain from jaw to elbow; shooting pain from jaw to elbow; still used arm but with a lot pain; heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 2, single (Lot number: FC3181) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (ongoing), notes: not for sure for years; "High blood pressure" (ongoing), notes: not for sure for years. Concomitant medication(s) included: ONGLYZA [SAXAGLIPTIN] taken for diabetes mellitus, start date: 2018 (ongoing); NOVOLOG taken for diabetes mellitus, start date: 2018 (ongoing); AMLODIPINE taken for blood pressure abnormal, start date: 2018 (ongoing); LANTUS taken for diabetes mellitus, start date: 2018 (ongoing). Vaccination history included: BNT162b2 (Dose1, Time: 10:30 AM, Anatomical site of injection: Left upper shoulder, Route of administration: Intramuscular, Batch/lot number: FC3180), administration date: 13Aug2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Whole left arm, neck, jaw was shooting pain from below ear, jaw, top shoulder to elbow", "Shooting pain in muscle", "couldn't straighten but elbow it would lock up". The following information was reported: MYOCARDIAL INFARCTION (disability) with onset 03Sep2021 at 10:00, outcome "unknown", described as "heart attack"; PAIN (disability) with onset 03Sep2021 at 10:00, outcome "recovered", described as "shooting pain from jaw to elbow"; PAIN IN EXTREMITY (disability) with onset 03Sep2021 at 10:00, outcome "not recovered", described as "still used arm but with a lot pain"; PAIN IN JAW (disability), NECK PAIN (disability), ARTHRALGIA (disability) all with onset 03Sep2021 at 10:00, outcome "recovered" and all described as "very sore left side started in left jaw under ear, down to neck to top of shoulder/shooting pain from jaw to elbow". Therapeutic measures were taken as a result of pain in jaw, neck pain, arthralgia, pain, pain in extremity. Therapeutic measures were not taken as a result of myocardial infarction. Clinical courses: No prior vaccinations. Had very sore left side started in left jaw under ear, down to neck to top of shoulder to shoulder part that area to left elbows was like she was having heart attack, also had shooting pain from ear to elbow every few mins when shooting pain got to elbow it spread out like electric hiting a wall then over, over 24 hrs a day for one year about 13Sep2022. No med not able to take pain med. OTC only used artiest sub on arm. The patient still used arm but with a lot pain.  Follow-Up (22Sep2022): Follow-up attempts are completed. No further information is expected.
Information has been received from a health department nurse concerning a 5 year old female who on 11/23/99 was vaccinated with a dose of varicella virus vaccine live. The nurse reported a case of break through varicella between May and July 2004. The case appeared mild. It was unknown if medical attention was sought or if treatment was required. A product quality complaint was not involved. Follow up information was received from the nurse who reported that on 6/14/04 or 6/15/04, the patient developed varicella after being exposed at her day care to an infectious, unvaccinated 5 year old male child who had a fever and greater than 100 lesions and vesicles on his face, chest, back, arms, and legs. The patient had seven lesions, no vesicles, and no fever. The varicella lasted four days and the patient recovered. The nurse reported that there were no adverse experiences related to vaccine, but rather evidence that the vaccine prevented the child from developing a severe case of varicella. No further information is expected. The nurse also reported that the patient's brother developed varicella after therapy with varicella virus vaccine live (WAES0501USA00131).
This is a spontaneous report received from a contactable consumer or other non-HCP (the patient), program ID: (005570). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), May 2021, single dose, for COVID-19 immunisation. Medical history not reported. No concomitant medications. The patient had muscle twitching (muscle twitches/first dose last May and still have them), with outcome of not recovered. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient is healthy and not on any medication at the time of report. Information on batch/lot number for BNT162B2 requested and will be submitted if/when received.
Initial information received on 26-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP (nursing student). This case involves a 32 years old female patient who experienced Tinnitus and little achy, while she received vaccine FLUZONE QUADRIVALENT. Reporter stated that this is the first time she received FLUZONE QUADRIVALENT. The patient's past vaccination(s) included Tdap vaccine 2 months before. The patient's past medical history, medical treatment(s) and family history were not provided. No concomitant therapy was taken. On 17-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm. On 18-Oct-2018, the patient experiencing ringing in the ears 1 day following the administration and on an unknown date, patient was a little achy (latency not reported) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient saw an ENT because of the ringing in her ears that hadn't gone away and the ENT told her to call manufacturer and also her PCP told her that ringing in the ears can be a side effect of the flu. No lab test was reported. Final diagnosis was Tinnitus and little achy. It was not reported if the patient received a corrective treatment. The patient did not recover from ringing in the ears (reported as hadn't gone away) at the time of report and outcome of little achy was not reported. List of document held: none.
Pt rec'd COVID-19 vaccine at 817am. He completed his observation time and walked to his car. He started feeling dizzy. Continue to drive to work and began feeling worse. Sudden onset of pain at injection site that began to shoot into his neck and down into left lower extremity. He returned to the vaccine clinic. BP normal, HR 135. C/O severe left jaw, neck and left arm pain. Brief throat itching. Pain waxes and wanes. EMS notified and patient transported to  for evaluation. Pt monitored in ED, treated with Benadryl, Morphine, Robaxin and discharged to home . Symptoms resolved in ED.
felt something running down her arm when she got the vaccine; has a 1.5 inch whelp at injection site; black and blue at injection site; burning feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 08:00 (Lot number: EN6202) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: She takes high blood pressure medications. The patient took concomitant medications. Vaccination history included: Bnt162b2 (She received the first dose on 05Feb2021. It was given in her right arm. Lot: EL9264.), administration date: 05Feb2021, when the patient was 66 years old, for covid-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovered" (02Mar2021), described as "felt something running down her arm when she got the vaccine"; VACCINATION SITE INFLAMMATION (non-serious) with onset 02Mar2021, outcome "not recovered", described as "has a 1.5 inch whelp at injection site"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 02Mar2021, outcome "not recovered", described as "black and blue at injection site"; BURNING SENSATION (non-serious) with onset 02Mar2021, outcome "unknown", described as "burning feeling". Therapeutic measures were taken as a result of limb discomfort. Additional information: For event- She didn't watch but felt something running down her arm when she got the vaccine. At first she thought it was excess medication. The nurse put a band aid on her arm. She felt a burning feeling. When she got home she took the band aid off. The band aid was filled with blood. She has a 1.5 inch whelp at the injection site. The injection site is black and blue. She is wondering if this is from the way it was administered or if it was a reaction to the vaccine. She didn't know if she should put ice on it. Is this typical or as a result of the vaccine. She has never had this happen before. Any adverse event did not result in emergency room or physician office. No follow-up attempts are possible. No further information is expected.
Client given the bivalent Covid vaccine as primary dose. Client has not received the monovalent series.
Chills; temp of 100; headache; body aches; This is a spontaneous report from a sponsored program. A contactable male consumer (patient) reported that, on an unspecified age he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization at the workplace hospital. The patient medical history and concomitant medications were not reported. 05Mar2021 the patient experienced chills, temp of 100, headache and body aches. It was reported that patient received last vaccine 17days ago wanted to know can you get side effects after the vaccine. Patient yesterday had chills, temp of 100, headache and body aches. The patient underwent lab tests and procedures which included body temperature: 100 on 05Mar2021. The outcome of events was unknown.  There were not any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 68-year-old female patient who received HBV (Engerix B adult) (batch number 4EA77, expiry date 11th September 2022) for prophylaxis.   On 23rd September 2022, the patient received Engerix B adult. On 23rd September 2022, unknown after receiving Engerix B adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of adult Engerix- B, which led to expired vaccine used.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments: US-009507513-1801USA005992:
Superficial thrombophlebitis (Mondors disease); This is a literature report.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "nonsmoker" (unspecified if ongoing); "obstetric" (unspecified if ongoing), notes: delivery of a now 9-year-old son through Cesarean section, without any complication. Concomitant medication(s) included: NIFEDIPINE. The following information was reported: PHLEBITIS SUPERFICIAL (hospitalization), 1 week after the suspect product(s) administration, outcome "recovered", described as "Superficial thrombophlebitis (Mondors disease)". The event "superficial thrombophlebitis (mondors disease)" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 140/97 mmHg; Body mass index: 39.7, notes: Units: kg/m2; Body temperature: 37 Centigrade; Heart rate: 84; Imaging procedure: 2, notes: the left breast was assigned a BIRADS-2 category; Inspection of the left breast: 3 linear creases in the left breast, notes: 1 vertical in the lateral aspect and 2 horizon- tal in the superior and inferior aspects of the left breast; did not reveal any abnormality; left axillary vein was examined: no evidence of deep vein thrombosis; Mammogram: showed fatty breasts with no abnormalities; showed fatty breasts with no abnormalities; Oxygen saturation: 100 %; Respiratory rate: 18; Ultrasound breast: showed thrombosed superficial veins, notes: with absent flow and loss of compressibility; Ultrasound Doppler: lack of flow in the tubular structure thrombophleb; Ultrasound scan: no suspicious finding to suggest breast cancer, notes: or lymphoma and ruled out other considerations; superficial thrombophlebitis corresponding to the, notes: sites of the creases; showed no evidence of lymphadenopathy. Therapeutic measures were taken as a result of phlebitis superficial.; Sender's Comments: Based on the available information in the case, the causal association between the event phlebitis superficial and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The patient received a 2nd booster dose. The patient did not recall having a prior booster dose, but the database reports that the patient had one on 11/9/2021.
Patient became nauseated with mild dry heaving, pale skin color, and her lips turned pale and then bluish. Patient was brought back into the clinic and sat down with emesis bag.  she refused laying down initially.  Cool washcloth was applied to forehead then back of neck. Drinking sips of water that she brought herself.  We added sips of orange juice and laid her down.  HR 84, Sats 98%, RR 20, BP . Her lips became pink with sitting up but pale when lying back.  After several minutes of sitting and sipping OJ, she was much better.  Nausea subsided, sats remained 98%.  Child reported she felt well.  Patient left with guardian with instructions to take to the ER if patient became swollen, developed a rash, became SOA, choking, etc.  Guardian verbalized understanding.
Yet to receive second dose more than 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Tinnitus, left ear, high pitched ringing, unresolved, increasing in intensity at times, always present
I had reduced taste no fever, no muscle aches no chills, no cough or shortness of breath. I decided to go to the ER to get a covid test because I was scheduled to work that day and I did want to make sure I was not positive due to the loss of taste but if I was not working that day I would not have got medical care. I did have loss of taste for some more days but after that it was resolved (around 3 days).
Patient received first dose of COVID vaccine and became diaphoretic and light headed. Upon further assessment patient advised substernal chest pressure that wasnt relieved with rest. 911 called for 12 lead. V/S monitored and patient turned over to EMS upon their arrival.
Patient's mother returned a couple hours after immunization stating patient was "twitchy" and "fussy", "crying". Patient was taken to back office, RN administered BENADRYL as ordered by MD. Patient was monitored for approximately 1 hour during which he calmed, and went to sleep in mother's arms.
Severe headache - midnight 9/10/21  Nauseous - midnight 9/10/21