chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness to left arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness to left arm/vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were Hydrochlorothiazide, Atorvastatin, Bisoprolol Fumarate, Baby Aspirin for drug use for unknown indication.  On 28 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: O25A214) via unknown route for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced the event, tenderness to left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Mar 2021 the outcome of event, tenderness to left arm was resolved.
Cough, sore throat, headache, body aches, fagigue, nasal congestion.  All symptoms have continued now for 2 days.
Patient came back to pharmacy after 7 days 9/27/10. Patient experience swollen & warm & pain in the site of injection after 24 hours. Then 2nd day experience chills. She took TYLENOL for the pain. After 5 days, swelling & pain disappear.
No additional AE; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a Healthcare Professional and refers to a patient of an unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, thepatient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1879864, expiration date: 19-OCT-2023) administered for prophylaxis (strength, and route of administration were not provided). provided) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent (lot# S030249, expiration date 06- FEB-2022). According to the reporter, the temperature excursion was 46 degrees Fahrenheit for a time frame of 8 hours on 05-SEP-2022, without any previous temperature excursion.; Sender's Comments:  US-009507513-2209USA002570:02242096 US-009507513-2209USA002469:02242101 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109 US-009507513-2209USA002532:02242109 US-009507513-2209USA002779: US-009507513-2209USA002722:02242109
I had the flu shot a week before  i had the booster 15 hours after booster I got shakey, pain in armpit and right breast that went into neck and down my spine. after a week I went to hospital emergency room. still having the same pain in right breast and pain when i take a deep breath or bend over.
Patient appeared to the pharmacy two days after her vaccination event with red rash around her deltoid muscle on the arm. She said her arm feels hot and itchy. She also mentioned that she had the same experience when allergy shots were administered to her in the past.
arm swelled up, went to physician office, examined for blood clot, was found not to be clot, physician treating with antiobitic/steroid for cellulitis
Pt. states he is still experiencing excruciating pain after receiving flu shot on 12/13/12. Pt. states pharmacist administered shot in his shoulder blade rather than deltoid & required medical attention due to pain.
Chills, fever, severe headache, vomiting , nausea, light sensitivity, body aches, exhaustion, mild discomfort at injection site
On May 29, 2021, mammogram showed an area that needed further imaging. Additional imaging was completed on June 22, 2021.   Needle biopsy was completed on July 1, 2021. I was given the diagnoses of Invasive ductal carcinoma, grade 3, Hers2 negative of the left breast on July 6, 2021. Partial Mastectomy with three sentinel nodes removed done on September 1, 2021. Chemo port place October 18, 2021, Chemo started on October 28, 2021. Radiation will start January 25, 2021.
Patient previously received Moderna vaccine on 12/23/2020 and received Pfizer vaccine on 1/20/21 instead of 2nd Moderna vaccine.  No adverse reactions to vaccine noted.  Patient has been informed that at this time she does not need any further doses of COVID vaccine
C/o headache, cough, sneezing  off/on x1 wk.
no adverse event; expired diluent administered; reconstituted with expired diluent; This spontaneous report was received from a pharmacy student regarding a patient of unknown gender and age. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-DEC-2019, the patient inadvertently received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot# S018593 with expiry date of 17-JUN-2021 reconstituted with expired sterile diluent (DILUENT MRK) lot# M009800 with expiry date of 12-SEP-2018 for prophylaxis (dose and route of administration was not reported) (Product preparation issue and Expired product administered). No adverse effects were reported. No product quality complaint (PQC) was reported.
Induration/swelling, redness, itching at injection site.  Blotchy rash down left arm and up left shoulder.  Itchy throat. Wheezing. Cough. Started 7 days after vaccine administered.
1/30/21 at 1pm developed lower lip swelling, progressed down chin to L cheek, no shortness of breath or chest pain Following day extremely tired  Started on prednisone x 5 days with Pepcid.  Symptoms totally resolved after 2 days
Pt developed a quarter sized red, hot, tender spot that was sore to the touch. The site was swollen the first 24 hrs post vaccine and then red spot was flush to skin at 48 hours post vax.
received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 26th June 2022, the patient received the 2nd dose of Havrix. On 26th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: No side effects were reported. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
No adverse event; Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in the refrigerator on 07-JUL-2023 and date of administration of vaccine was 07-JUL-2023 there might be another date in June2023 but not sure and did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:master case
she woke up today with a swollen bruised area and a knot up under it that wasn't there before either; she woke up today with a swollen bruised area and a knot up under it that wasn't there before either; Swollen arm/swollen arm and forearm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6206) at the age of 85 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (She says that the LOT for the first dose she got on 12Feb2021 is either EL962F or EL9627 and expiry is 04Jun2021), administration date: 12Feb2021, when the patient was 85 years old, for COVID-19 immunisation. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 10Mar2021, outcome "unknown", described as "Swollen arm/swollen arm and forearm"; CONTUSION (non-serious), RASH (non-serious), outcome "unknown" and all described as "she woke up today with a swollen bruised area and a knot up under it that wasn't there before either". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: she had her second shot 5 days ago, and the swelling wasn't there then but she woke up today with a swollen bruised area and a knot up under it that wasn't there before either. She says she would like to know if she needs to do something about it, or will it eventually go away. She doesn't understand stuff that is explained to her, she is well past that stage. She says her left arm just started swelling today, she got up this morning and noticed it was bigger than the other. She says she has done no treatment for the swelling. Medical Conditions: Caller says she has the same old age diagnosis and the same medications that she has taken all the time, they have never changed. No further details provided about these medications. She says that she is just a happy old lady.  No follow-up attempts are possible. No further information is expected.
Headache first day, aches for two days to date, nauseated stomach on and off, pain in lymph nodes on side of injection (can't feel swelling or see swelling), pain moving down left arm over two days. Other than a 2 hour reaction to 2nd Covid vaccine dose and sore arm from vaccine, don't have reactions to vaccines.
Narrative:  Patient developed shortness of breath, constriction feeling in throat.  stated felt like he needed an inhaler. This occurred shortly after receiving first dose of Moderna covid vaccine. Patient received Albuterol inhaler for treatment and was discharged home. He was instructed not to receive a second dose of moderna vaccine.
Received bivalent Covid October 2022. January 2022, new onset maculo-papular rash trunk and scalp and persistent diarrhea. Skin biopsy consistent with but not diagnostic of drug interaction. Colonoscopy, stool tests unrevealing. CBC, CMP, CRP not indicative of inflammatory process. There was no fever, malaise, weight loss, or signs/symptoms of dysfunction of heart, lung, liver, kidney. Relationship to vaccine administration 3 months earlier seems unlikely other than induction of IGG-4D, but in an abundance of caution I'm reporting this to you. (Note: I am the patient, but I'm also a physician.)
Noticed a metallic taste over entire surface of tongue, and numbness at back of tongue along right lateral edge, and underside on right of tongue, as well as inner right gum line. Injection given on left deltoid at 12:00PM. S/S intensifying over four following hours. Temperature elevated at 3:45 PM at 98.8 degrees normal temp is low 97 degrees.
Stomach ache initially at 9 pm., vomited at 11:00 pm.  No treatment given.
I have allergic asthma and I was cleaning an office and I had a dust exposure, I was then having a very hard cough, sore cough, and it was hard to breath and developed and fever. I was taking some OTC medication and after 12 days the cough was not going away. I went in and my doctor gave me an antibiotic and a steroid. We did do a chest x-ray to make sure I did not have pneumonia and that was ruled out as well and we really nailed down that it was my asthma that was the problem. When I went off that however it came back. I am now on the medication full time, and I was diagnosed with exacerbated asthma and have medications added to my daily medication routine.
Sudden onset of hives all over body and face. These began the night of November 28, 2021. Severity increased significantly starting November 30, 2021. Along with the hives everywhere that would appear in random spots all over my body and face, the joints in my hands were extremely tender to touch and painful. They were also very red and itchy for about 4 days straight. I am still experiencing the hives all over my body today. My doctor diagnosed it as Dermatographia. I had been taking Zyrtec in the day and Benadryl at night which helped with the itchiness. The random redness and dermatographia however would not subside with these antihistamines. The itchiness is unbearable when not taking an antihistamine.  My dermatologist recommended I take Xyzal for 30 days at dinner time to resolve all symptoms of dermatographia. Began this treatment on January 5, 2021. Have seen much improvement with this treatment.    At the same time, on November 30th around 3pm I got severe heartburn, pain when swallowing, acid reflux, and esophagus tightening as if there were something stuck in my throat. I have never had anything like that before. Those GI symptoms resolved after 2 rounds of Prilosec. Last dose finished January 3, 2021.
CHILLS; MUSCLE PAIN/ACHE; FEVER; FATIGUE/ TIREDNESS; HEADACHE; This spontaneous report received from a consumer concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 23/JUN/2021) .5 ml, administered on 07-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced muscle pain/ache. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced fatigue/ tiredness. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, muscle pain/ache, fatigue/ tiredness, and headache on 09-APR-2021, and fever on 08-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210435796.
Headache eye itching and right facial swelling around eye . Previously took Jansen vaccine, Pfizer as booster dose Narrative:
Awoke at 1:30 am 10/18/2023 with nausea and abdominal pain, cramping, loose BM.  Continuing throughout the day
I experienced unusual vaginal bleeding for almost 3 whole months and went to see my doctor who did a vaginal exam. He stated that the vaginal bleeding was normal.
Her right arm hurts from her shoulder to her mid-upper arm. Hurts to put her bra on, lift her arm above her head, reaching back, and lying on that side.  Has also had a headache, says her eyes hurt since 2 days ago when it was received. Started yesterday (1/12/16) and was off and on. Worse today (1/13/16) compared to yesterday. Has also had an upset stomach, worse today. She is right handed and had her flu shot given in her left arm the same day.
Information has been received from a physician with allergy to penicillin who on 06-APR-2009 was administered ZOSTAVAX (Merck) (lot # not available) intramuscularly by a pharmacist. The physician stated that it was sore at the time of injection. The outcome of the patient's adverse event was not reported. Additional information has been expected.
Blood diarrhea. Diarrhea started 2 days s/p Rotateq. Blood in stool started 4 days post Rotateq. 03/07/07-records received for DOS 2/27/07 well baby visit and 3/3/07 ER visit for diarrhea, stools almost hourly, green with 2 stools that contained small amount of blood. Diaper rash.  PE:WNL
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021. This spontaneous case was reported by a nurse and describes the occurrence of BLOOD CREATININE INCREASED (Serum Creatinine increased) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Bladder cancer, Congestive heart failure and COPD. Concomitant products included FUROSEMIDE, METOPROLOL, LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN D NOS and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]). On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced BLOOD CREATININE INCREASED (Serum Creatinine increased). At the time of the report, BLOOD CREATININE INCREASED (Serum Creatinine increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood creatinine: serum creatinine Serum Creatinine went from 1.5 to 1.87. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.
Rash at right arm just below vaccination site. Also induration ans tenderness at injection site.
fever for one day.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for one day.) in an adult male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 PYREXIA (fever for one day.). At the time of the report, PYREXIA (fever for one day.) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment medication was not reported.   Reporter did not allow further contact
Reaction began 6 days after vaccination.  My arm , from injection site to elbow was swollen, red, hard, hot and very itchy.  Condition has lasted approximately 4 days.  Itching has stopped, swelling has gone down, redness it better, not has hot to the touch or hard.  I hope to  be getter in the next day or two.  I did not go to the doctor.
Redness and swelling at injection site with streaking towards clavicle, swollen, tender lymph nodes on same side. Patient treated with Doxycycline and Benadryl by PCP.
Left thigh swollen to knee, firm, warm and tender to touch, redness. No fever. On 03/28/2002 put on Keflex.
9:50am, client approached nurse 5 minutes post-vaccination complaining of heaviness in her chest, and a swollen tongue. Client was escorted to our emergency area for assessment and observation. History of allergies to nuts, garlic, flax seed, and black pepper. Also history of asthma, and need for epi pens twice in the past. 9:56am pulse 100, O2 100%, BP 150/112, c/o tingling in lips, chest heaviness, and swollen tongue. 10am, Complaints of chest heaviness is worse, no shortness of breath, client is able to talk. 10:10, pulse 93, O2 100%, BP 162/110. Tourniquet placed above vaccine injection site. Medical Director contacted, advised to start with Benadryl based on history and high heart rate. As Benadryl was about to be administered, client increased complaints of chest heaviness, and not being able to swallow. Benadryl (50mg) and Epi (0.3) given at 10:19am.  Benadryl was IM in right deltoid, Epi was given in right thigh. 911 called simultaneously. 10:25, O2 100%, pulse 109, reports breathing easier. 10:26 EMS arrived, client transported to local hospital.
my arm hurt a little bit, I've had other shots that hurt 10x worse, like pneumonia shot (6years ago).; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration in 2015 (Batch/Lot number was not reported) as single dose for immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included tetanus shot for immunization and experienced arm sore. Suspect product was provided as pneumococcal 13-val conj vac (dipht crm197 protein). When the patient was reporting on events with covid vaccine (received on 16Mar2021), he mentioned that his arm hurt a little bit, he had had other shots that hurt 10x worse, like "pneumonia shot" (6years ago in 2015).  Patient also said that his arm was much more sore after the tetanus shot (10 years ago in 2011) than the Pfizer shot (not specified). The outcome of the event was unknown.  No follow-up attempts are possible; Information about batch number cannot be obtained.
Lump in left arm where she got injection; Lump on the neck; Couldnt lift arm; Temperature of 100 degree; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: No adverse event removed as relevant history. Laboratory test added.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 3/22/2022 ADENOCARCINOMA, LOWER THIRD OF ESOPHAGUS G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 3/22/2022 LEFT HEART FAILURE G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 3/22/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Pacemaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown", described as "Pacemaker".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.