chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; swelling at the the arm of the injection; heat generation at the the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat generation at the the arm of the injection), RASH (Rash) and VACCINATION SITE SWELLING (swelling at the the arm of the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was reported by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (heat generation at the the arm of the injection) and VACCINATION SITE SWELLING (swelling at the the arm of the injection). On 03-Mar-2021, the patient experienced RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, VACCINATION SITE WARMTH (heat generation at the the arm of the injection), RASH (Rash) and VACCINATION SITE SWELLING (swelling at the the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment activities for event was also done with ice.   This case was linked to US-MODERNATX, INC.-MOD-2021-072805 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and had no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072805:Dose 2
Within 15 minutes after shot, painful band around chest (bra line) on L side (lasted 2 hours), warm flush through upper body and dizzy (10 seconds) and pins and needles and numb in left arm down to fingers (as of today, has not disappeared). General feeling of achy first week. Occassionally bad headaches that last 2 days in the first 2 weeks. On 11th day after shot got tingly and numb and over sensitive (feels like sunburn) on left side of face and body that continues still today. This also afffects my tongue and roof of mouth, my jaw line and my teeth. I did see a destist in case I had an infection. He found nothing. Also on 11th day tingly and numbness down left leg that has continued even now. I have had a charlie horse in my L calf and my muscles tense up in my bicep and calf often. Nausea during the second week after shot.
nausea; Body aches; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (nausea) 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 23-Dec-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headaches). On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, MYALGIA (Body aches), HEADACHE (Headaches) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was unknown.
My arm hurt after first shot; dry mouth; swollen and numb lips; swollen and numb lips. Even my cheeks felt numb; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on 16Jan2021 as dose 1, single and on 06Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history included psoriasis on scalp and eyes. Concomitant medication included estradiol (ESTRACE) vaginally was taken for an unknown indication from an unknown date. The patient received Itraconazole as past drug and experienced contact dermatitis diagnosis. In Sep2020, the patient suffered a scratch from a rose bush and was prescribed itraconazole x 9 days for contact dermatitis diagnosis. On an unknown date in 2021, the patient experienced her arm hurt after first shot.  Also, after first shot, she started experiencing very dry mouth and swollen and numb lips.  Even her cheeks felt numb.  There was no saliva in her mouth so bought some Biotene and a spray for mouth and gel for tongue. She had no other symptoms, no dry eyes, no joint pain. Sjogren's test came back negative.  Tomorrow would be 2 months from the first shot and the dry mouth and swollen and numb lips were still a concern and ongoing.  When she touches lips and cheeks, it feels like the numbness feeling after going to the dentist when you are waiting for the Novacaine to wear off. The last couple of days, the dry mouth was a little better due to gargling and sucking on candy so there was a little saliva, but lips were so dry they were stuck like a bandaid to teeth and have to pull them away from her teeth. She was not on any other medications besides Estrace cream, applied vaginally a couple of times/week. She was very active; walk and bike. In Sep2020, I suffered a scratch from a rose bush and was prescribed itraconazole x 9 days for contact dermatitis diagnosis. Perhaps it was related to her taking itraconazole since she read that product has many side effects. She had an appointment with an internist tomorrow, 16Mar2021, for further evaluation. The outcome of event My arm hurt after first shot' was unknown. The outcome of the event dry mouth was recovering, while the outcome of remaining events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient called 7 weeks after getting the imz to state that his shoulder has been hurting intermittently.
Menstrual cycle completely out of sync; have been hormonally grossly imbalanced since my anticipated period on the 1st of November (incidentally the same date of my first intramuscular vaccine injection). An irregular period has never happened to me in my life.  I got a fever of 101 degrees F which has persisted to this moment; my arms were so debilitatingly sore I can no longer lift them up.
Within 6 hrs. headache. Headache lasted 1 day and a half. Slightly dizzy. Had trouble sleeping because of being achy. ADVIL helped.
On the early morning hours of Monday was woken up out my sleep. I had serve diarrhea for 5 hours  and then it stopped.  Has been fine every chance.   **believes that Moderna vaccine has Polyethylene Gylcol in it and wants a warning added that if you take Miralax daily to not take before/after receiving vaccine.
Approximately 1/2 dose dripped down arm; needle loose on syringe; Approximately 1/2 dose dripped down arm; A spontaneous report was received from an other healthcare professional concerning their patient, 77 years old, female patient who received approximately 1/2 dose dripped down arm/under dose, needle loose on syringe/syringe connection issue.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received the first of two planned doses of mRNA-1273 (Batch number: 012M20) on 28 Jan 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.   The patient received the second of two planned doses of mRNA-1273 (Batch number: 023M20A) on 25 Feb 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.    On 25 Feb 2021, the patient received approximately 1/2 dose dripped down arm and needle loose on syringe. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events approximately 1/2 dose dripped down arm and needle loose on syringe was considered recovered/resolved.; Reporter's Comments: This report refers to a case of vaccine underdose and syringe connection issues for mRNA-1273, lot # 023M20A with no associated AEs. Based on reporter's causality the event exposure via skin contact is assessed as unlikely related to mRNA-1273
I got SOB and I went into an Acute Respiratory Failure. I had to be hospitalized. My oxygen was only at 50%. They did chest X-ray, sleep study, blood work, EKG, and urine sample.  I am on several different medicines now.
3.5 days after 1st shot: Full-body burning skin (feeling like a severe sunburn, but not itching;  no urge to scratch) accompanied by chills that lasted about 3 hours (3am-6am).  No elevated  temperature.  My arm  became very sore at 6.5 hours after the shot, but the soreness went away after about 1.5 days.  At 3.5 days, the arm soreness returned accompanied by the full-body burning skin and chills.  The skin burning lessened about 6 hours after initial onset, but remains  No visible rash or skin change of appearance.  Eyes do not appear yellow/jaundiced.  No treatment as yet
pt recv vax; administered 4.5mg instead of 2.5 mg, devel a very sl fever;
fell asleep, and experienced narcolepsy for the next three weeks; hypothyroid; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered at the left arm on 24Mar2021 13:00 (Lot number and expiry date not reported) as single dose for COVID-19 immunization. Medical history included asthma, chronic kidney disease, hypertension, drug hypersensitivity (penicillin allergy) from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included benazepril taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (EFEXOR) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; and allopurinol taken for an unspecified indication, start and stop date were not reported.  Historical vaccine included first dose of BNT162B2 for COVID-19 immunization on 03Mar2021 13:00 at left arm (age at vaccination was 57 years) for COVID-19 immunization. The patient previously took morphine, iodine, levaquin, lisinopril and gabapentin experienced drug hypersensitivity. On 27Mar2021, the patient experienced fell asleep, and experienced narcolepsy for the next three weeks and had hypothyroid with outcome of recovering. Therapeutic measures were taken as a result of the events.  Information on the lot/batch number has been requested.
Mom called the office and said she was going to bring patient to the clinic because he was turning red, short of breath, and fast heart palpitations. Doctor said that she need to take him to ER. Mom took him to ER. Pt was managed with steroids and albuterol via nebulizer.
Feeling run down after receiving Shingrix and it putting them on the couch; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable.  No additional information on patients or product. Pharmacist stated patients have reporting feeling run down after receiving Shingrix and it putting them on the couch. Pharmacist stated the side effects mentioned are on the VIS so they were expected. Consented to follow up.
Just not feeling well; Chills; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Just not feeling well), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021 at 12:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced MALAISE (Just not feeling well), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Just not feeling well), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non significant follow-up : email id for reporter updated.
states that the injection was given in the middle of the upper arm and reports experiencing an immediate sharp 7/10 pain after the injection. She since has experienced the sharp pain radiating down the left arm to the left wrist and up the left arm to the shoulder and left side of the neck. She has noted a decreased ROM in the left arm and states she has had to modify ADLs including the way she dresses herself. She also verbalizes that she is unable to grasp heavy objects with the left hand. She states that the pain is made worse with certain movements. She has used ice on the extremity occasionally with minimal relief
Breakthrough case admission after two vaccines Pfizer 3/2/2 Lot# EN6202;  Pfizer 3/23/21 Lot# ER2613
Fever of 103.4; headache; body aches; nausea; fatigue; weakness; dizziness; Received my 3rd "booster" shot and had very strong side effects.; Received my 3rd "booster" shot and had very strong side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 Lot Number: FF2587) via an unspecified route of administration arm right on 16Sep2021 14:45 as a single dose for covid-19 immunisation. Medical history included hairy cell leukaemia from an unknown date and unknown if ongoing recovered hairy cell leukaemia patient (4 years into remission), drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (FLU) taken for an unspecified indication from 09Sep2021 to 09Sep2021; fluoxetine, buspirone, finasteride taken for an unspecified indication, start and stop date were not reported. The patient previously took augmentine [amoxicillin sodium; clavulanate potassium] and experienced drug hypersensitivity, vancomycin, and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation, bnt162b2 for covid-19 immunisation. Historical vaccine dose 1, (Lot number: EN6206 expiry date was unknown) via unspecified route of administration at right arm on 16Sep2021 as a single dose for COVID-19 immunisation, dose 2 (Lot number EP7533 expiry date was unknown) via unspecified route of administration at left arm on 16Sep2021 02:45 PM.  Location of injection for vaccine received same date: Pfizer BioNTech - Right, Pfizer BioNTech  Right. Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm List of any other medications the patient received within 2 weeks of vaccination: Fluoxetine, Buspirone, Finasteride. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 103.4 on 17Sep2021. Received his 3rd "booster" shot and had very strong side effects. Fever of 103.4, headache, body aches, nausea, fatigue, weakness, dizziness. His on second day now and still dealing with side effects however fever was under control so far without Tylen finally. His recovered hairy cell leukemia patent (4 years into remission) and wanted extra protection before his travel overseas in Oct.. Outcome of the event was recovering    Follow-Up (21 Sep2021): Follow-up attempts are completed. No further information is expected.
Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction; Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction; This is a literature report for the following literature source(s): "Diagnostic challenge in evaluating the risk and management of allergic reaction(s) to sars-cov-2 vaccines", Annals of Allergy, Asthma and Immunology, 2021;.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "Atopic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), ALLERGIC REACTION TO EXCIPIENT (medically significant), outcome "recovering" and all described as "Pruritic symptoms, facial urticaria, tongue swelling, wheezing progressed to full body hives and difficulty breathing/occurring within 30 minutes after first dose/Anaphylactic reaction". The patient underwent the following laboratory tests and procedures: skin test: negative, notes: to PEG; negative, notes: to JNJ-78436735 (Johnson and Johnson); positive, notes: to polysorbate 80; ngative, notes: to BNT 162B2; negative, notes: to PEG; negative, notes: to JNJ-78436735 (Johnson and Johnson); negative, notes: to polysorbate 80; negative, notes: to BNT 162B2. Therapeutic measures were taken as a result of anaphylactic reaction, allergic reaction to excipient. Anaphylactic reaction to BNT162B2 vaccine occurred within 30 minutes after the first dose, following treatment with epinephrine, IV diphenhydramine, and IV steroids, her symptoms improved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. 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.
Arm tenderness, nausea, headache, muscle fatigue, muscle soreness, dizzy
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 22-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
pt recv vax 15APR97 & 23APR97 pt devel more than 50 lesions;f/u info reported that a PCR analysis was positive for betaglobin & there negative for varicella zoster virus;
On 12 November 2021 Severe right ankle gout flare up, I took Allallopurinol (allopurinol 100 mg oral tablet) and colchicine (colchicine 0.6 mg oral tablet) On 1 December 2021, I received cortisone injection
My shoulder is painful, particularly when I put on my shirt, jacket or try to roll my shirt collar down. Particularly when I raise my arm. Ibuprofen doesn't seem to help. I am supposed to take 2nd injection soon, but I am reluctant to take it. Please advise.
Narrative: Patient reported pruritic rash on right thumb, left arm and bilateral buttocks after second dose of Moderna COVID-19 vaccine after receiving vaccine at outside facility. Outside facility treated with Medrol dose pack. Actual date unknown.
pediatric dose given to adult patient; Wrong technique in product usage process; pediatric dose given to adult patient, gave an additional pediatric dose; Wrong technique in product usage process; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 69-year-old male patient who received HBV (Engerix B pediatric) (batch number HN5BE, expiry date 16th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B pediatric) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th June 2021, the patient received Engerix B pediatric. On 10th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product and wrong technique in product usage process. On 11th June 2021, the patient experienced adult use of a child product and wrong technique in product usage process. On an unknown date, the outcome of the adult use of a child product, adult use of a child product, wrong technique in product usage process and wrong technique in product usage process 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 Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The reporter stated that on 10th June 2021 where a pediatric dose of ENGERIX B was given to an adult patient.  The following day, 11th June 2021 HCP called the patient back in and gave an additional dose of ENGERIX B pediatric dose.  The reporter mentioned no prior adverse event. The reporter did not give consent to follow up. Additional supportive Information: The pediatric dose given to adult patient which leads to adult use of pediatric product and wrong technique in product usage process.