chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: checked pulse, gave water and 2 glucose tablets
Pt was administered 0.2 ml undiluted of Covid-19 5-11 vaccine. Med error discussed with mother.  Pt had no reaction after first Covid vaccine.  That evening at 5 pm, Mother reported pt felt warm, no fever and a little cranky.  no further reactions reported over the weekend.  Left message for mother to update on Monday June 20, 2022 and no call back from mother.
circle on arm is warm; Red arm red circle around injection site; Circle part is hard; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard) in a 29-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 21-Mar-2021, Pfizer (Dose 1) on 21-Mar-2021, Pfizer (Dose 1) on 21-Mar-2021 and Pfizer (Dose 2) on 22-Apr-2021; for COVID-19 prophylaxis: Moderna (Dose 3) on 10-Nov-2021, Moderna (Dose 3) on 10-Nov-2021, Moderna (Dose 3) on 10-Nov-2021 and Moderna (Dose 4) on 19-Jun-2022; for Covid-19 Prophylaxis: Moderna Bivalent (Dose 5) on 03-Oct-2022. Past adverse reactions to the above products included Chills with Moderna and Pfizer; Muscle soreness with Moderna and Pfizer; No adverse event with Moderna, Moderna Bivalent and Pfizer; and Pain in arm with Moderna and Pfizer.    On 18-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Sep-2023, the patient experienced INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard). At the time of the report, INJECTION SITE WARMTH (circle on arm is warm), INJECTION SITE ERYTHEMA (Red arm red circle around injection site) and INJECTION SITE MASS (Circle part is hard) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-741386 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741386:Same patient, monovalent moderna vaccine
Swelling and discoloration of left shoulder.  Weakness/discomfort of left arm.  Atrophy of left deltoid.
A physician reported that a female child received Prevnar vaccine on 01-OCT-2001. She subsequently developed an injection site reaction characterized by swelling, bruising and puffiness for 48 hours. No additional information was available as of the data of this report.
armpit is swollen a little more; rash at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more). At the time of the report, VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE LYMPHADENOPATHY (armpit is swollen a little more) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Company Comment: 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.; Sender'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.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with expired dose of PNEUMOVAX23 (lot # J009827, expiration date 10-AUG-2014) (dose and route of administration not provided). No adverse effect reported. Additional information has been requested.
Patient fainted after receiving  his dose of the vaccine.   Pharmacist was alerted by another customer that patient fell out of his chair.  Patient was responsive as soon as pharmacist arrived.  Patient states he does not think he hit his head. States he has fainted from needles in the past, but failed to inform pharmacist on VAR sheet. Patient denied emergent medical treatment and left 15 minutes later with his father.
My lymph node at my left shoulder close to my neck is swollen, tender and hurts and I can feel the node moving.
Patient was fainted after a couple minutes of receiving  a flu shot. Patient was feeling fine when she left the room. She walked out the room immediate toward her father in the waiting area. Patient felt better a couple minutes later and left the pharmacy with her parents.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In or around 10-APR-2017, the patient received the ZOSTAVAX (lot number and expiration unknown) unknown for its intended purpose of the prevention of shingles. Shortly thereafter, the patient suffered facial numbness, dropping of the eyelid and corner of the mouth and began to have difficulty chewing. In or around December of 2017, the patient presented to his physician for this injury and was diagnosed with Bell's palsy. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, low of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Bell's palsy was considered to be disabling. Upon internal review, Bell's palsy was considered to be medically significant. Additional information has been requested.
Swelling in Right Knee started within 2 weeks, diagnosed with juvenile idiopathic arthritis 3 months after vaccines.
He has a temperature of 100.1 but a lot of muscles aches and pain; He has a temperature of 100.1 but a lot of muscles aches and pain; He has a temperature of 100.1 but a lot of muscles aches and pain; This is a spontaneous report from a non-contactable Nurse. This Nurse reported for a male patient (Son) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 08:20 at single dose for covid-19 immunisation. Medical history was not provided Concomitant medications included Lisinopril for a little hypertensive. He received a shot (COVID Vaccine) yesterday (19Dec2020 at 08:20), today he called on for work, and he says that he has a temperature of 100.1 but a lot of muscles aches and pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The shot was given on Thursday afternoon.  Friday woke with headache and common side effects.  Took a Tylenol that afternoon and felt great.  Saturday around 2:30 a.m. I was awakened by severe chest pains.  I thought, was I having a heart attack?  I was afraid to go back to sleep, but eventually did.  When I woke I called Dr. office to get a referral to an internist. Months later I read about heart inflammation.  I   have not had any symptoms of chest pains since, but am concerned about getting a booster.
Patient reported to primary medical doctor nurse on 3/15/07 that she was experiencing swelling of arm at injection site; states affected area was approximately 8cmx8cm in size and slightly (1/4"swelling); rate pain at "3 on scale from 1-10, 10 being worst pain experienced; denies any fever; shortness of breathing; symptoms resolved 4 days after injection
Moderna 1st dose given to 16 year old.  No treatment needed.  Only adverse event patient could report was a very sore arm which hurt for a few days.
About 3 minutes after vaccine, pt began having having tickling in throat similar to prior allergic reactions.  she reported usually she'll take benadryl x 1, then x2 after about 15 minutes, at that point she'll know if she's getting worse or not.  She took 25mg diphenhydramine po x 1--no worsening of symptoms.  mild improvement, took 2nd benadryl and was driven home (about 10 minutes away) with strict precautions.  dx mild allergic reaction.
Starting 4 days following my 2nd vac. dose, I've had episodes of unusual inflammation in my knees or ankles at different times and lasting for a week at a time, causing pain, stiffness and swelling. This has continued for six weeks though there were also periods when I was symptom free. I hope that my immune system has returned to normal. I have not heard of these symptoms reported previously.
Pharmaceutical product complaint; Only  liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA27Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reported a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The patient received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140231:Same reporter- Patient 5 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
Pt had what sounded like an afebrile grand mal seizure at 9:30 AM lasting 30 sec. on the day after her 4 m shots.
No adverse event; Received Expired Bivalent booster beyond 12 hours post puncture; 14 years patient received Expired Bivalent booster Moderna; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years patient received Expired Bivalent booster Moderna) and NO ADVERSE EVENT (No adverse event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022 at 2:40 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years patient received Expired Bivalent booster Moderna). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years patient received Expired Bivalent booster Moderna) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Bivalent booster beyond 12 hours post puncture) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 years patient received Expired Bivalent booster Moderna).    Concomitant medications details were not reported by the reporter. Vial size was reported as 2.5 ml. On 26-OCT-2022, vial was initially stored in refrigerator. Vial was in the refrigerator the entire time for >24 hours. Vial was first punctured on 26-OCT-2022 at 10 A.M. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-665655 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-665655:Same reporter
Immediately after getting first covid vaccine 9/23/2021 I felt weak, tired and extremely sleepy. Second covid shot 10/21/2021 I notice that I was having a hard time maintaining my weight. I lost ten pounds in one week after second shot went from 191 to roughly 179 pounds in weight. I never lost my appetite but I was constantly loosing weight.  I went to a nurse practitioner sometime in November 2021, test where ran I was diagnosed with diabetes and a blood sugar over 400. This was the fastest appointment that I could get.   2nd opinion Test were ran and I was diagnosed with type 1 diabetes   3rd opinion went to see an actual endocrinologist
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history and drug/allergies reactions was not provided. On 13-MAR-2019, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # N030364, expiration date 06-MAR-2019; dosage schedule and frequency were not provided) orally as prophylaxis (expired product administered). No adverse effects were reported. No clarifying or additional information was provided.
Hiberix vaccine reconstituted with a MMR diluent; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 4-year-old male patient who received Hib (Hiberix) (batch number X29YB, expiry date 3rd November 2020) and (batch number S031904, expiry date 19th June 2022) for prophylaxis.   On 6th February 2020, the patient received Hiberix. On an unknown date, the dose was an unknown dose. On 6th February 2020, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were reported as follows: The reporter stated that the Hiberix vaccine reconstituted with a MMR diluent and administered to patient, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution.
Pt. arm was sore, entire arm hurt and had some redness at injection site and had trouble raising/moving arm. Pt. reported being nauseous, with headaches, stomach pains, and fever up to 104 x 3 days. Meds: Ibuprofen.
The only reaction I had to the first two shots of this vaccine was a sore arm at the injection site for a few days. The booster shot also produced a sore arm but within 24 hours, I developed several chills, shaking, fever, headaches, loss of appetite, and inability to sleep.
Narrative: Patient reported headache and fatigue following his first COVID vaccine dose received 1/22/21. Also noted a burning sensation at the injection site during administration.
Patient described having redness and bumps around injection site. No swelling or bruising reported. Patient stated she does not have itch. Advised using hydrocortisone cream to relieve.
COVID-19; Allergy; Hives; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPERSENSITIVITY (Allergy) and URTICARIA (Hives) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Unknown. On an unknown date, the patient experienced COVID-19 (COVID-19), HYPERSENSITIVITY (Allergy) and URTICARIA (Hives). At the time of the report, COVID-19 (COVID-19) had not resolved and HYPERSENSITIVITY (Allergy) and URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of COVID with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of ALLERGIES and HIVES was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; Persistent weakening of connective tissue/ ligaments; connective tissue laxity; Spontaneous rupture of tendons; chronic pain; dislocation of joints spine, hands, wrists, feet and ankles; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 12Jan2021 (Lot number: El0142) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ek5730, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 45 years old, for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The following information was reported: ASTHENIA (disability), CONNECTIVE TISSUE DISORDER (disability), LIGAMENT DISORDER (disability) all with onset 02Feb2021, outcome "not recovered" and all described as "Persistent weakening of connective tissue/ ligaments"; TENDON LAXITY (disability) with onset 02Feb2021, outcome "not recovered", described as "connective tissue laxity"; TENDON RUPTURE (disability) with onset 02Feb2021, outcome "not recovered", described as "Spontaneous rupture of tendons"; PAIN (disability) with onset 02Feb2021, outcome "not recovered", described as "chronic pain"; JOINT DISLOCATION (disability) with onset 02Feb2021, outcome "not recovered", described as "dislocation of joints spine, hands, wrists, feet and ankles". The events "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "persistent weakening of connective tissue/ ligaments", "connective tissue laxity", "spontaneous rupture of tendons", "chronic pain" and "dislocation of joints spine, hands, wrists, feet and ankles" were evaluated at the physician office visit and emergency room visit. Therapeutic measures taken included orthopedic splints.; Sender's Comments: The events considered as intercurrent conditions and unrelated to product bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine). This case will be reassessed upon receipt of follow-up information.
This spontaneous report as received from a patient and his wife refers to the approximately 87 year old male patient. The patient's pertinent medical history was reported as asthma and he had drug reactions/allergies with Aspirin. On an unknown date of 2006 the patient was vaccinated with ZOSTAVAX (dose, route, lot#, frequency not reported) as recommended by the physician. Concomitant therapies included prednisone (manufacturer unknown), ADVAIR and PROAIR. On an unknown date of June 2011 the patient got Shingles. The rash lasted about 3 weeks. It was reported that the patient was still dealing with the resulting nerve pain. Towards the end of the report, the patient got on the phone and provided with some answers to this report. The patient stated that pain in mostly on his right side near his waistline. He was hospitalized twice for the pain (hospitalized) once on 01-AUG-2011 for three days (03-AUG-2011) and again on 28-SEP-2012. It was reported that the patient sought medical attention (saw the physician). There was no lab diagnostics studies performed. An unspecified medication for the nerve pain was given to the patient in the hospital. The outcome of the event got shingles and rash was reported as recovered at the time of the report. Rest of the events had not resolved. Additional information has been requested.
Sore arm for two days. Diarrhea. Developed Bell's Palsy after six days.