chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache  "mild lightheadedness"  Narrative:  (1323)10min s/p Covid vaccine injection pt c/o "mild  lightheadedness"(1324)119/63, HR 56, 98%RA, 16RR, T97.8, (1331) 128/80, 58,  98%RA. (1332) pt. speaking w/ MD regarding medical hx, Negative health hx  reported. Pt asked by MD to remain in clinic for approx 15 minutes for further  eval. (1337) Pt observed texting on personal cell phone. (1340) Ortho VS  obtained: Supine 115/64, 62, Sitting 117/67, 61, Standing 123/74, 65. 1345 MD  assesses pt before she exits clinic. Pt ambulates indep. from clinic site gait  controlled et steady.
Patient called states "I have a swollen lymph node under my left arm. Been here for two days. No pain or fever" will take med if pain or fever occurs. To go to ER or contact private physician if symptoms worsen.
Neck pain; Back pain; Fever; This spontaneous case was reported by a physician and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE, FLECAINIDE, METOPROLOL and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-052077 (E2B Linked Report).; Sender's Comments:  MOD21-052077:
i received the moderna vaccines on December 30, 2020 & January 28, 2021. The day after my second vaccine I began experiencing blood nose 3-4 x daily which is still occurring intermttently but less frequently & extremely heavy vaginal bleeding that continued non stop through 4/26/21. I tried to seek help through a Clinic and was turned away because I was told I could bring them COVID from the ICU. I was told to go to our local ED, which I know would amount to nothing except a consult to the OBGYN who would not be coming in to see me for irregular bleeding. (I worked at this hospital for 5 years- I know how it operates) I again tried to be seen at the clinic and was turned away. After filing a complaint, I was told I needed to be reestablished as a new clinic patient- which in itself is absurd.  I continued to bleed and get weaker, short of breath, pale, severe headache and pain in my eyes, dizzy, fatigued. Eventually leading into edema of my Left leg, shortness of breath, chest pain, I could not raise my arms and severe fatigue. This was not regular cycle kind of bleeding either.  may 10 - Hgb was 6.7. Ultimately I was hospitalized and transfused 2 units PRBC?s.- 10 hours after receiving the vaccine I started bleeding and didn?t stop for 95 days isn?t just coincidence.   I have since had an endometrial biopsy- neg. stress test- neg Hgb is now only 10.7.  Was hospitalized on 5/10/21 with hgb 6.7 and given tranfusions of 2 units of packed red blood cells.
Thursday the 16th of September he was extra tired and a little bit of a headache on Friday he had a little bit of fever and on Saturday he told me he didn't feel good and I gave him some cough drops for the sore throat on Sunday he was sleepy and tired and complain of sore threat and saying he felt something in his chest like and at 3am he went to my room and he didn't feel well he said he was exhausted his jaw was hurting really bad, his chest was tight his felt was racing and he was holding his left arm and I called 911 and an ambulance took him to the ED and did and EKG  and an Echo they diagnosed him for myocarditis after they ruled out heartburn and he was admitted. Infectious disease doctor was alerted.
Pt was given her 1st dose of HPV. She became light headed dizzy & clammy. Pt vision became blurry. Pt was assisted to lay down & vitals were taken. BP @ admission - 109/71 BP @ occurrence 100/61
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: mouth numbness after chewing dramamine tablet after administration.
It's been almost two month from my covid 19 vaccine and today I started to have soar arm again in the same place where the vaccine was injected. I hadn't had any problem. The soar arm came suddenly to; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 07:30 (Lot number: EW0161) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penisiline allergy" (unspecified if ongoing); "Sea food" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirine, reaction(s): "Allergy to aspirine". Vaccination history included: Bnt162b2 (Dose: 1,Time: 07:30 am, lot number: ER7534, Anatomical Location: Arm Right.), administration date: 19Mar2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17May2021 08:00, outcome "not recovered", described as "It's been almost two month from my covid 19 vaccine and today I started to have soar arm again in the same place where the vaccine was injected. I hadn't had any problem. The soar arm came suddenly to". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination other medications as predinisone during the first dose of the vaccine. It's been almost two month from my covid 19 vaccine and at reported day patient started to have soar arm again in the same place where the vaccine was injected. Patient hadn't had any problem. The soar arm came suddenly today, patient had it since this morning and still have pain. Is the only symptom that has come back. Patient took panadol for the pain. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered:  Health Clinic/ Administration facility.  No follow-up attempts are possible. No further information is expected.
As described by parent;pt went limp, pale, face lips & nails pale;cool to touch;skin color returned pink spontaneously;referred to ER via EMS;
Dizziness, CoughWheeze, Congestion, Fatigue, Injection site pain, swelling at injection site Narrative:
Within first 24 hrs developed erythema and induration which has continued to increase in size. VS stable. Placed on KEFLEX PO for cellulitis.
started with shingles rash  left chest about  about 2/26/2021 (<14 days after receiving vaccine)
On July 5, 2018, 7 days after the MMR vaccine she broke out in a rash all over her face. Then on 7/26/18, she was complaining about hand pain. On Saturday, 7/28/18 it started to swell and be warm around her wrist. She was taken to ER hospital and labs were drawn and x-rays were taken. It was determined she had a positive ANA and other labs indicating possible rheumatological condition after no hx of any immune problems. Undoubtly it was the MMR.
This spontaneous report was received from a physician refers to an 18 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On an unknown date in early October 2018, the patient was vaccinated with GARDASIL 9 (strength, dose, lot# and expiry were not reported) via intramuscular route for prevention of Human papillomavirus (HPV). On 18-OCT-2018, the patient came to physician's office and reported "with illness, puffy eyes, headache, back and neck and facial pain, sore throat and cervical adenopathy. The physician also reported that the patient received a work out for mononucleosis and pharyngitis. He was prescribed with oral steroids (unspecified). On 21-OCT-2018, the patient went to the emergency room and was admitted in the hospital. The reporter informed that the patient was given treatment with morphine for pain, intravenous steroids (unspecified) and nasogastric tube intubation was also placed. The patient had blood cultures and the result revealed as positive. The reporter reported that the patient was still hospitalized. The outcome of ill-defined disorder, pharyngitis, infectious mononucleosis, lymphadenopathy, oropharyngeal pain, facial pain, neck pain, back pain, headache and eye swelling was not recovered. The causality assessment was not reported. There was no product quality complaint (PQC) reported.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). On unknown dates, the patients administered improperly stored doses of ROTATEQ (dose, frequency, route and expiration were unknown, lot #M005732, lot#M031651, lot# M039434, lot# M042821) for prophylaxis. The temperature excursion was at 9 Celsius Degree to 25 Celsius Degree for 4.5 hours. There was no previous temperature excursion. Data logger involved. No adverse effects were reported in any patients. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA006063: US-009507513-1709USA006065: US-009507513-1708USA010866: US-009507513-1709USA006064.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case (same reporter)
After receiving the first dose of vaccine at 5:30 pm noticed swelling around and below elbow with resdness and warmth to touch. Denies pain
diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine; This is a literature report.  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATOMYOSITIS (medically significant), 5 days after the suspect product(s) administration, outcome "recovered", described as "diagnosis of dermatomyositis, occurring in association with the COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (0-55): 154 IU/l, notes: elevated; Antibody test: remarkably elevated; Antinuclear antibody: No antibodies detected; Antinuclear antibody negative: No antibodies detected, notes: Jo-1; Aspartate aminotransferase (5-34): 256 IU/l, notes: elevated; Biopsy: revealed features of interface dermatitis with, notes: superficial perivascular mononuclear inflammation and dermal edema; revealed overexpression of major, notes: histocompatibility complex class I, inflammatory cells, necrotic fibers, and atrophic fibers organized in a perimysial pattern, suggesting an immune-mediated myopathy of a dermatomyositis type; Blood creatine phosphokinase (29-168): 2804 IU/l, notes: first day of presentation; 4476 IU/l, notes: 3 days; 1135 IU/l, notes: decreased significantly; Normalized, notes: 12 weeks after initial presentation; Computerised tomogram abdomen: No internal malignancy; Computerised tomogram pelvis: No internal malignancy; Computerised tomogram thorax: No internal malignancy; Enzyme level test: Normalized, notes: liver enzymes normalized twelve weeks after initial presentation; Flow cytometry: lymphoma disorder unremarkable; Hepatitis B: negative; Hepatitis C: negative; Additional cutaneous findings: included multiple vesicles and erythematous, notes: papules on the right upper extremity and reticulated, erythematous patches on both of her thigh; remarkably elevated; unknown results; showed basal vacuolar alteration with foci of, notes: necrotic keratinocytes; Mi2-a: No antibodies detected, notes: Mi2-alpha; No antibodies were detected, notes: Mi2-beta; No antibodies were detected, notes: PL-12; No antibodies were detected, notes: PL-7; physical examination: violaceous, poikilodermatous scaly plaques were, notes: observed on the anterior aspect of the neck and chest; Tuberculosis: negative. Therapeutic measures were taken as a result of dermatomyositis. She had received an initial dose of the COVID-19 vaccine 5 days before the onset of the symptoms.  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 available reported information, the causal association between the event dermatomyositis and the suspect drug BNT162B2 cannot be excluded.
bruising on lt arm-rash/no fever/no neuro sx; MD told mom that it was a rxn to pertussis in vax;
muscle pain/ muscle ache in the area of the shot; soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and pain. On an unknown date, the outcome of the injection site pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced muscle pain, soreness and injection site pain. The reporter wanted to know how long does it lasts.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 71-year-old female patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 7th November 2018, the patient received the 2nd dose of SHINGRIX. On 7th November 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and vaccine administered at inappropriate site. In November 2018, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising, injection site pain and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient may have received SHINGRIX too far below the deltoid, which might led to vaccine administered at inappropriate site. The patient experienced injection site pain during administration and severe bruising was visible a few days later in the same arm. The reporter did not administer the vaccine and was therefore not certain of this. The reporter did not consent to follow-up. The reporter would prefer follow-up via phone call.
TWO DAYS AFTER VACCINE ARE STARTED HAVING TROUBLE WITH MY LEFT ELBOW (PAIN) THEN IN THE COMING WEEKS PAIN THROUGHOUT LEFT ARE AND FORARM AND TINGLING FINGERS.
My heart rate elevated to 120bpm; This side effect was unexpected, uncomfortable; This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day.; This 25- year-old female patient contactable consumer (reported for herself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL3247), via an unspecified route of administration, on 03Feb2021 at 1:00 PM (at the age of 25-years-old) as a single dose for COVID-19 immunization, in left arm. She has had no other vaccines in the past 4 weeks. Patient has not taken any medications in the past 2 weeks. The patient has no relevant medical history and is not taking any concomitant medications. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03-FEB-2021 13:05, she reported: my heart rate elevated to 120bpm approximately 5 minutes after receiving the Pfizer COVID19 vaccine. This side effect was unexpected, uncomfortable and resulted in me being unable to work for the rest of the day. This side effect lasted approximately 36 hours. Patient did not receive any treatment. The outcome of the events heart rate elevated and unable to work the rest of the day was recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.
No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, 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 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023. Treatment medication was not reported.  The case was created for 7th patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine administration date was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Woke at 1:30 pm - fussy - said legs red hip to toes per parent. Per ED note - Erythema without induration warm to touch & tender & TYLENOL given.
Redness & swelling around injection site, since given 4-4-11. Measurements Rt leg 8 1/2cm x 7cm Lt leg - 13 1/2 cm x 10 1/2 cm. PEDIAPRED & TOPICORT cream given.
Pediatric dose (10 microgram) was given to 12 year old child (30 microgram) .No side effects are reported.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LICHEN SCLEROSUS (Lichen Sclerosus) and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination.   No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced a regulatory authority and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor). The patient was treated with PROGESTERONE for Lichen sclerosus, at a dose of 1 dosage form and ESTRADIOL for Lichen sclerosus, at a dose of UNK dosage form. At the time of the report, LICHEN SCLEROSUS (Lichen Sclerosus) and DISCOMFORT (increased until it was uncomfortable enough that I went to a doctor) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: lichen sclerosus (Inconclusive) Lichen Sclerosus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Patient stated that the event was diagnosed around 6 weeks after the second dose, and the diagnosis was lichen sclerosus. Patient stated it was an autoimmune disease in the skin in the genital area.  Patient was treated with a steroid cream (it improved symptoms but she has to keep using it, it does not go away).
Left arm swollen/injected at site and large area around injection, tenderness at site of injection and upper left arm, bubbly almost vesicular/linear reaction at site and also pt feels achy all over.
Myalgia, Fever, Rash,  chills Narrative:  onset of s/s 2.5 days post injection. rash localized around injection site, with flu like s/s.
On 1/16/2021 , 4 hours after I had my Covid-19 injection my left arm started to hurt and was started to get real hard in the muscle.  I took 2 naproxen and 2 tizandine.  I could not use my left arm from 4:00 pm-10:00 pm.  On 1/17/2021, I woke up and my left arm was real hard and I could not use my arm all day and night.  I took 2 naproxen, 2 tizandine and 1/2 tramadol.  On 1/18/2021, I woke up and my left arm is back to normal.