chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-338616, US-MODERNATX, INC.-MOD-2021-338611, US-MODERNATX, INC.-MOD-2021-344166 (E2B Linked Report). This case was linked to MOD-2021-338604 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-344166:MOD21-148785 US-MODERNATX, INC.-MOD-2021-338611:Master case (same reporter) US-MODERNATX, INC.-MOD-2021-338616:Master case (same reporter)
Fever/chills, Headache 07/26; Cough and diarrhea for 3 days.  Motrin and Tylenol.  B/W CBC/Lyme
This spontaneous report was received from a registered nurse refers to an adult patient of unknown age. On 02-OCT-2010 the patient accidentally was vaccinated with COMVAX, 1 mL, intramuscular (lot # was not reported) instead of a dose of pediatric RECOMBIVAX HB. No adverse effects were reported. This is one of several report received from the same reporter. Additional information has been requested.
Patient received a fourth dose of pfizer covid vaccine despite being ineligible (45 years of age, no immunocompromising conditions). No severe adverse events are expected.
Pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. No treatment medication was provided.
High fever x 3 days followed by runny nose and cough. Treated fever with MOTRIN and was only able to bring it down to 102. Fever finally broke 5/12.
Symptoms:  Fever of 102.7, Chills, and Weakness. Treatment:  Extra Strength Tylenol Tylenol reduced fever to low-grade 100.2
Aches all over, achey joints onset. Per HCP follow up report-I assume I would have included the numbers you are looking for at the time of the report if they were available. 8 months later I don't even remember filling out the form and could not get the info from chart. Patient probably got the vaccine at a flu shot clinic.
Injection site pain; Tiredness; Headache; Chills; Nausea; Muscle pain; Feeling unwell the evening of the injection which was February 25, 2021; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: Jun2021) via an unspecified route of administration in the left arm on 25Feb2021 at 11:15 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and COVID-19. The patient had confirmed case on 03Jan2021. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had unknown allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 25Feb2021 at 21:00, the patient experienced injection site pain, tiredness, headache, chills, nausea, muscle pain and feeling unwell the evening of the injection. The same symptoms persisted the next day, then again alleviated on 27Feb2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, tiredness, headache, chills, nausea, muscle pain, feeling unwell was recovered on an unknown date in Feb2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
My joints; shoulders, elbows, hips, knees and ankles became very sore and painful. Had difficulty bending and rising. Am still having pain in hips and knees. Aleve seems to help. Back seems to have spasms also.
1. Mild joint aches started shortly after receiving shot and occur off and on since then.  More common on left side.  More common in ankle but have also felt in wrist, shoulder, etc.  2. Mild pain started in upper inner part of left calf around 5/15.  Generally persistent.  Feels somewhat tight and warm sensation inside but not to touch.
lt thigh swollen to knee w/red area 2" x 3"; had sl fever; no other problems;
"Covid arm"; warm; red 6 inches wide; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm/vaccination site reaction, warm/vaccination site warmth, red 6 inches wide/vaccination site erythema.  The patient's medical history included emphysema, high cholesterol, hypothyroidism, high pulse rate and high anxiety. Concomitant medications reported were propranolol, escitalopram, bupropion, raloxifene, levothyroxine, atorvastatin for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 20 Feb 2021, ten days after receiving the vaccine the patient experienced the events covid arms which was warm and red 6 inches wide.  Treatment details included cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events covid arm warm, red 6 inches wide was unknown.
Received both doses of vaccine then 2.5 weeks later got covid; Received both doses of vaccine then 2.5 weeks later got covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (patient) reported that a male patient of an unspecified age (reported as Age: 80; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single dose; then second dose via an unspecified route of administration on an unspecified date in Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both of the Pfizer COVID 19 Vaccines back in Jan2021. About 2.5 weeks later the patient was diagnosed with COVID on an unspecified date. He received the "Bamlan" back in January. He was asking if he will need to take another COVID vaccine. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
headache; redness is coming back; it's warm to the touch; face started getting blotches; lips were tingling; welt on their arm; skin was crawling; blured vision; Eyes felt gritty; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm) and FORMICATION (skin was crawling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product HYDROXYZINE for an unknown indication.    The patient's past medical history included Hashimoto's disease since an unknown date and Asthma since an unknown date. Concomitant products included MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HYDROXYZINE (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VISION BLURRED (fogginess). On 02-Feb-2021, the patient experienced VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty) and FORMICATION (skin was crawling). On 06-Feb-2021, the patient experienced URTICARIA (welt on their arm), RASH MACULAR (face started getting blotches) and PARAESTHESIA ORAL (lips were tingling). On 15-Feb-2021, the patient experienced ERYTHEMA (redness is coming back) and VACCINATION SITE WARMTH (it's warm to the touch). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with CLINDAMYCIN for Infection, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm), FORMICATION (skin was crawling), RASH MACULAR (face started getting blotches), PARAESTHESIA ORAL (lips were tingling), ERYTHEMA (redness is coming back), VACCINATION SITE WARMTH (it's warm to the touch) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Osteoarthritis; Arthralgias in their fingers/arthralgias in the hand; Had more arm pain for longer hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had more arm pain for longer hours), OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included LORAZEPAM for Anxiety and Insomnia, ROSUVASTATIN and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Had more arm pain for longer hours). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis) and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand). At the time of the report, PAIN IN EXTREMITY (Had more arm pain for longer hours) and OSTEOARTHRITIS (Osteoarthritis) outcome was unknown and ARTHRALGIA (Arthralgias in their fingers/arthralgias in the hand) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient might have had some COPD that flared up, the patient thinks that might not be due to the shot. No treatment information was reported.   This case was linked to MOD-2021-338672, MOD-2021-338621 (Patient Link).
Pt received first dose of pfizer vaccine 12/3/21. Second dose was administered sooner than 21 day period. Second dose administer 12/17/21. Patient reported no adverse side effects.
Left deltoid warm, red, swollen, painful, 7 cm X 8 cm.
I woke up after a normal night's sleep and found that everything was spinning.  Was dizzy and could not properly walk.  After trying to drink a bit of water, fainted and vomited it all back up.  I was weak and tired.  Slept or rested all day and by late afternoon was able to hold down some toast and by evening symptoms had resolved.  Clearly, I am not sure that this was vaccine related since it occurred 2 wks after vaccination but felt should be reported.
Tested PCR Covid positive more than 2 weeks after receiving 2nd Covid 19 vaccine.  #1 dose 03/11/2021.  Symptomatic with fatigue, nausea, loss of taste.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 46 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Inforrmation has been received from a medical assistant referring to an 8 week old male patient. No relevant medical history or concurrent conditions were reported. On 17-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Moderate muscle pain at injection site starting about 4 hrs after vaccination.  Chills, shaking, fever, body aches, headache starting about 8 hrs after vaccination, starting to abate 24 hours after vaccination.  Severe enough that patient took one day off work.
Information has been received from a registered nurse concerning a 17 month old male who on 04-MAY-2007 was vaccinated with a dose of VARIVAX (Oka/Merck) (656287/1508F). There was no concomitant medication.  Approximately 04-OCT-2007, the patient developed chicken pox.  The patient had more than 30 vesicular lesions, mostly on his head, arms and upper torso.  No other symptoms were noted.  Medical attention was sought through an office visit.  There was no product quality complaint.  Additional information has been requested.
Hot in injection site; Red area looked as little rush; Swollen injection site; Pain in injection site; Redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site). At the time of the report, VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the event was unknown
stronger after 2nd dose; left chest compression like pain; left arm extension pain; lung scarification; headache; erratic fever; Chills; Balance issue; stiff joints of  elbow ,knee +wrist; left arm pain arms shot area; This is a spontaneous report from a contactable consumer (patient). This 70-year-old male patient received dose 2 of BNT162B2 (lot number EN6207) intramuscular on 12Mar2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization. Medical history included COVID-19 from 22May2020 to 19Jun2020 (tested positive 22May2020 and tested negative 19Jun2020). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BN162B2 (lot number EN6198) intramuscular on 19Feb2021 at 09:00 as a single dose in the left upper arm for COVID-19 immunization and experienced light headedness, off balance, extreme tiredness, constant headache, extreme muscle pain in left arm, extreme joint pain, left chest compression-like pain, left arm pain arms shot area, erratic fever/chills, and stiff joints of elbow, knee and wrist. On 12Mar2021 at 15:00 (as reported) for two days following each of the vaccination shots the patient experienced the common symptoms most people experienced: severe and constant headache, left arm pain arm's shot area, erratic fever/chills, balance issue. He also had extreme stiff joints of elbow, knee, and wrist. On the third day after shots these symptoms diminished to near zero although there were 2 symptoms not mentioned yet. The patient had  awful left chest compression-like pain and left arm extension pain. These 2 pains lessened between shots but became stronger after the 2nd shot. They lessened since the 2nd shot nearly 2 months later. The patient notified his doctor after the first show and his doctor assured him the symptoms were not allergic reactions. They were confident the heart was not the source of chest pain. A magnetic resonance imaging (MRI) of chest showed lung scarification. The patient had a future test for left arm extension pain. The events were reported as serious for persistent/significant disability/incapacity. The patient did not receive any treatment for the events. The outcomes of headache, left arm pain arm's shot area, erratic fever/chills, balance issue, stiff joints, left chest compression-like pain, left arm extension pain, and lung scarification were recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021206053 Same patient and suspect product, different dose and event.
PT EXP SEVERE STINGING AND PAIN AT SOI.  TREATMENT PT COUNSELING.
Immunization Date: Wed 7/19/2017; Immunization: Tetanus; Injection Site: Left Upper Leg (thigh) Pictures available upon request; Thursday the injection site was raised, red and appearing like a small hive Friday morning the injection site was red and spreading by Friday evening the injection site was red, raised and extremely warm to the touch (could feel heat through her shorts). By Saturday afternoon the injection site was extremely red, raised and growing. Friday evening I had marked the parameter of the rash and by Sunday it had surpassed the marked outline. Sunday the redness was dissipating, and by Monday morning, the rash was barely visible. During the weekend, my daughter was in extreme discomfort, she mentioned that her shoulder and hips hurt as well as her leg I had reached out to the RN at Dr.'s office on Friday and they instructed me to give her antihistamine, ice & warm when tolerated. I was using Claritin & Benadryl. I went to the office on Monday to show them the pictures of the reaction, I was instructed to continue the above instructions. A few hours later, the RN called back and said that Dr. wanted to discontinue the Claritin & Benadryl and put her on Allegra 2x's a day for the remaining week.
tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine; tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Jun2022, outcome "unknown" and all described as "tested positive on 21Jun2022/ her son had all of the Pfizer covid vaccines/ had four booster all of the Pfizer covid vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive.  Clinical course: Reporter Stated her son tested positive on 21Jun2022; he is age 18 and does not know legally whether or not she would report on him, declined report and states her son is protective about his health information. Stated her son had all of the Pfizer covid vaccines and does not have the lots, dates, expiry dates, or NDC numbers of his Pfizer covid vaccines to provide as that information is not with her and is in her son's wallet. Caller stated she is assuming he can go online to report this. Her son who lives with her and is age 18 has ulcerative colitis and he is considered mildly immunosuppressive and had four booster all of the Pfizer covid vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 10.5 hrs after receiving the vaccinet, I completely lost control of my bladder function.  Urine came out of my body and I was not able to control it.  This lasted about 5 hrs.
Acute feb rxn & sz 2MAY91-faint pap mac viral exanthem no PH of sz;