chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little pain on the arm injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (little pain on the arm injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain on the arm injection site). At the time of the report, VACCINATION SITE PAIN (little pain on the arm injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.   This case was linked to MOD-2023-704425, MOD-2023-704245 (Patient Link).
Pt received Moderna #1. Approx 10  mins later pt was found in floor crawling to doorway asking for a nurse. Pt then started shaking until the Dr came and amonia stick used. Vitals obtained and were within normal limits. After amonia stick pt started sitting up and asked the Dr to look at her labs.  Incidence lasted approx  5 minutes.
Severe eye pain and our daughter could not look from side to side without pain.  Especially in the left eye.  Headache.  Vision was ok. She could hardly  move for two days, very sore right arm where the shot was administered, swollen and painful glands, sore throat, nausea, faintness, weakness all over, pox on chest, rough small bumps under eyes, an increase in head pressure in the days following, feelings of pressure around her brain, back of head, forehead, generally the whole head felt like "a shrinking cap was being pulled over it".
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored ROTATEQ (dose and lot # not reported). No adverse effects reported. The patient was also vaccinated with improperly stored GARDASIL (MARRS # 1303USA011920) and M-M-R II (MARRS # 1303USA011921). Additional information has been requested.
Diabetes neuropathy in Feet; Felt Light headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIABETIC NEUROPATHY (Diabetes neuropathy in Feet), DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product LEUPRORELIN ACETATE (LUPRON DEPOT) for an unknown indication.    No medical history was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and dose of LEUPRORELIN ACETATE (LUPRON DEPOT) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIABETIC NEUROPATHY (Diabetes neuropathy in Feet), DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DIABETIC NEUROPATHY (Diabetes neuropathy in Feet) was resolving and DIZZINESS (Felt Light headed) and PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant drugs were not reported.  The patient had diabetes neuropathy in feet and trouble sleeping due to neuropathy.  The reporter's causality for the events of Diabetes neuropathy in feet and sore arm with LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT) was no reasonable possibility. The reporter's causality for the event of felt lightheaded was not provided.  Treatment details were not given.  It was unknown whether the patient was enrolled in a covid-19 vaccine trial.
pt recvd vax & 24 hrs later exp fever & body aches; these sx resolved 48 hrs later;
Excessive redness, heat, tingling and swelling at injection site.  Sun sensitivity, Marble sized knot where injection was administered.
Swollen Lips; Numb Lips; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea). At the time of the report, LIP SWELLING (Swollen Lips), HYPOAESTHESIA ORAL (Numb Lips) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment information was not provided.
Pt husband received smallpox vaccine 2 weeks prior to presentation. He picked at a scab on her right thigh, and an ulcerated, dark lesion appeared with heaper bullous edges 6 days prior to presentation (10/3/05). No pain, fever, pustular drainage noted.
pt recv vax;exposed to case of chicken pox in daycare;MD stated pt devel herpes zoster;devel local papular eruption at site of inject about size of nickel;lesions progressed from papular to vesicular;did not sleep for 2 noc;lesions painful;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 20-FEB-2018, the patient was vaccinated with PROQUAD (dose and route of administration were not reported) lot # N023966, expiration date: 28-FEB-2019 for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). The vaccine was stored in 11 degrees Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. The excursion was detected by a Digital Data Logger. There was no adverse effects reported.
Had reactions such as difficulty breathing, fatigued, coughing, very congested, and vomiting.
Temp 105 deg. F, rash on 04/12/2002, irritable, runny nose.
Shoulder pain, soreness and redness of muscle under the vaccine site, swelling-present after 2 days still.
chronic headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (chronic headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  The patient's past medical history included Heart disease, unspecified. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Allergy to antibiotic, Penicillin allergy, Asthma, Diabetes, Obesity and Drug allergy (Temerol). Concomitant products included VITAMINS NOS for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (chronic headache). At the time of the report, HEADACHE (chronic headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   diabetes medication blood pressure medicine, Tyrod medications,anticoagulants No treatment information was provided.   This case was linked to MOD-2022-609257 (Patient Link).
Violent shivering; feels cold to himself; forehead feels hot; arm is very sore; arm is very sore-muscles; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2021, the patient received Shingrix. On 22nd January 2021, 5 hrs after receiving Shingrix, the patient experienced shivering, feeling cold, feeling hot, pain in arm and muscle pain. On an unknown date, the outcome of the shivering, feeling cold, feeling hot, pain in arm and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the shivering, feeling cold, feeling hot, pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follow: The case was reporter by patient's wife at 21:38:15. The age at vaccination was not reported. About 6 hours ago from the time of the reporting, the patient had a Shingrix vaccination and about an hour ago he began having violent shivering.  The patient felt cold to himself while his forehead felt hot (he was heavily covered up). The patient registers no temperature. His arm and muscle was very sore.
7/20/21  right armpit became swolen and sore  7/21/21 Same effects 7/22/21 same soreness swelling goes down half way 7/23/21 right arm became swolen and sore along with armpit soreness and swelling same 7/24/21 right arm sore and swollen same, added large, red, itchy, hot circle around injection area. Less armpit soreness almost no armpit swelling. 7/25/21 same arm soreness, same swelling, same circle. No armpit soreness, no armpit swelling. 7/26/21 less arm swelling, less arm soreness, circle area is  entirely itchy but not completely red. Only hot where red. Circle was blotchy top half, fully red on bottom half.  7/28/21 same with lesser red up top, still fully red on bottom.  7/29/21 same with lesser red up top, still fully red on bottom(about one inch left fully red at bottom) entire circle still itches -present
Patient stated she always has fatigue, body aches, fever upon receiving high dose flu shot but physician encourages her to still receive each year.  However, this year she had the following adverse reactions which she has not had in the past.  Patient had swelling of the upper arm, redness, shoulder pain (could lift her arm with discomfort, but much worse if putting weight on it...such as lifting something with her arm raised).  The injection site was hard and swollen and slightly pink/red when patient presented to me on 10/29/19.  The patient took Acetaminophen/ASA as well as applied Benadryl cream topically.  When asked if the pharmacist that administered the shot was sitting or standing the patient stated she was standing.
Diagnosed with Dermatitis Herpetiformis after a punch biopsy confirmed. Extreme itching and burning on back and trunk of body. Then pustules and papules developed. Prednisone was taken and a cortisone cream was ordered. Trying to remove gluten and iodine from diet. Having flare ups of skin eruptions on back and scalp.
first 10 days after vaccination I suffered 6 migraine headaches.  I continue to have reoccurring  headaches (not migraines) on a daily basis.
Approximately 4 hours after shots given, grabbed head to complain of head hurt, skin clammy, staring off, projectile vomiting. Has had temp of 101 or under since date of immunizations. Treated with Tylenol or Motrin 1 or 2 times per day PRN. Continues to complain of headache and stomach aches, awakens 1-2 times per night.
Approximately 2:30 AM pt awoke with hives, itching to arms, chest, she states her eyelids and lips were swollen and her throat slightly hurt. She self treated with ZYRTEC D. Symptoms resolved by 1/18/10. She contacted PCP, left message but was not called back yet.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "Caller is asking what she can do if she can't go to her 2nd dose schedule today"; MALAISE (non-serious), outcome "unknown", described as "not feeling very well"; PAIN (non-serious) with onset 01Mar2021, outcome "unknown", PAIN (non-serious), outcome "unknown" and all described as "she's feeling more achy than usual". Additional information: The caller's (name) return date for the 2nd dose is today, but she is not feeling very well. According to her, 3 days ago she's feeling more achy than usual. Caller is asking what she can do if she can't go to her 2nd dose schedule today. Medical Information: Were any unaddressed medical questions referred or forwarded to medical information: No. Is the reporter a healthcare professional (HCP): No? Occupation/Specialty: N/A. Is the reporter's contact information available to you or a sub-contracted party: Unknown? Is the reporter the prescribing HCP: Unknown; Name: Unknown; Address: Unknown; Occupation/Specialty: Unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 19Sep2021 .5mL of Emergent Biodefense anthrax vaccine Lot #300133A was administered to the 21y/o Female Pt who at the time was otherwise feeling well and had not pertinent history.  Within an hour of receiving the vaccine the pt felt sick, nauseous, and had abdominal paint.  The pt became extremely uncomfortable, began to hyperventilate and vomit violently; chief complaint was severe abdominal pain.   Myself and HS2  were called to the women?s head for a member on the floor by the toilet where we immediately began EMS interventions.  She was transported to Hospital by  EMS.  She was released within a few hours with no findings, and the ER doctor said they believe she was suffering a reaction to the anthrax vaccine.
arm pain; joint stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, 1ST COVID Booster), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; JOINT STIFFNESS (non-serious), outcome "unknown". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 7 bright red spot at vaccination site (2x3 inches), expanded with central clearing and raised border (4x6 inches).  By day 16 had resolved.  Mild itching.
Initial report received on 28 October 2009 from an investigator in a trial. A 73 year old male subject developed immune thrombocytopenia on 26 October 2009 i.e. 12 days after receiving an intramuscular injection of INFLUENZA VIRUS VACC USP TRIVAL A AND B HIGH DOSE, SUBVIRION-U or FLUZONE SV 2009-2010, on 14 October 2009 in left deltoid (Batch no. - UD12321). The subject had a medical history of chronic obstructive pulmonary disease, sleep disorder, benign prostatic hypertrophy with transurethereal resection prostate, hypertension, depression, squamous and basal cell cancer (details not provided). The subject stated that prior to his first study visit he picked a scab that bled for a longtime. The subject did not consult a physician regarding the bleeding problem and did not have any formal diagnosis nor did he report his at the first visit. On 26 October 2009, the subject started coughing up blood clots in the morning, leading to hospitalization on 26 October 2009. He was diagnosed with immune thrombocytopenia. Laboratory data information and corrective treatment details were not provided. The events of immune thrombocytopenia and coughing up blood resolved on 30 October 2009 and the subject was discharged from the hospital on 30 October 2009. According to the investigator, the event was related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
Initial unsolicited report received from a nurse on 14-OCT-2016. This case involves a female patient (onset age not reported) who was vaccinated with ADACEL (batch number, expiry date, route and site of administration were not reported) on April-2016. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed a large dark area around the upper arm; injection site was warm and feverish to the touch. The patient's laboratory data and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
eyes pink; eyes swollen; This spontaneous case was reported by a patient and describes the occurrence of CONJUNCTIVITIS (eyes pink) and EYE SWELLING (eyes swollen) 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 CONJUNCTIVITIS (eyes pink) and EYE SWELLING (eyes swollen). At the time of the report, CONJUNCTIVITIS (eyes pink) and EYE SWELLING (eyes swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-NOV-2021, the patient was tested positive for COVID-19 antigen test at home (suspected covid 19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and the reference number has been requested.; Sender's Comments: V0: 20211128784 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
1 of 3 nurse who rec'd Engerix-B experienced headache ("pressure on top of head like head was going to explode"). Experienced "immediately" p/1st of a series of 3 injects. Tx Tylenol & headache went away.
July 19 All over Muscle ache, Headache, Upset stomach, Fatigue,  soar arm. July 20 still sick. July 21 Dizziness started, still sick. July 22 still sick Missed work. July 23 a little better. July 26 filling suck again. July 28 Morning Ok by 2pm very sick Dizzy Headache across eyes, worse in left eye. Sick in stomach. July 29 sick missed work. Went to Dr. Ordered Meclizine 25mg, Ondansetron 4mg Tylenol 500 mg. July 30 home sick bad headache. July 30 Went to eye DR to check eyes at 4pm went to Emergency Room got CT scan blood work shot for headache. Aug 1ok. Aug 2 Woke up very sick Dizzy and Blurry vision. Aug 3 Woke up bad headache across eyes left side worse. Double vision light hurts eyes. Aug 4 Dizzy light headed double vision. Left Eye Went Crossed Eyed,  and bad pain left eye / head.  2:30 pm Went to ER again. Did more blood work and did a MRI, on head   examined by Neurologist did muscle test left side weaker then right side,  said he thought it might be a side effect from shingle shot, was given another shot for pain.  and prescribed  Methylprednisolone  pack and set up appointment with  Neurologist . Aug 5  Still double vision went back to Eye Dr. for the double vision.   Vision still poor in both eyesAug 6 Still double vision. Aug 7 Shaky tired and Double vision. Aug 9 seen Neurologist did some physical test. Said since symptoms started right after getting the shingle shot. he suspect that it is a adverse reaction to the shot. ,He prescribed another methylprednisolone pack They did several more blood test,  and He has order a MRA test (similar to a MRI) and a spinal tap. Planed for the week of the 19th. Insurance co causing delays. As of Aug 16 2019 Headaches mostly gone. No improvement on Double vision.  No improvement with vision. Still some Dizziness. Left Eye still Crossed.
The patient was seated and during the vaccination procedure the needle separated from the syringe containing the vaccine. At this point the patient was alerted and remained calm. The vaccinator alerted the pharmacist who contacted Moderna on how to proceed. It was determined that no more than one-half of the dose had been administered. The recommendation was to repeat the vaccination  with the additional one-half dose to provide a full dose for the first shot in a two shot series. This was done per protocol. The procedure was completed. The patient remained for the required 15 minute observation period and experienced no adverse effects and did not present any symptoms of adverse effects.
Patient became very weak, vomiting w/diarrhea, dysuria, vomiting and platelets dropped to 17000. Required platelet transfusion, steroids and hospitalization 11/14/2021-11/23/2021. He is now in rehab.
Episodes of muscle twitching and staring began 3 days after DTaP/Hib/Prevnar - lasted for several days. Now diagnosed with autism. Afebrile seizures. Speech and language delays and some atypical behaviors.
11/14/06 FluMist given, 11/16 c/o right neck ache, felt hot to mom, PE examination tender right posterior cervical. T/C neg. 11/19 expresses yellow nasal discharge (hx recurrent sinusitis), Rx given. 11/20 developed rash. 11/21  admitted to hosp DX HSP.   3/15/07 Received medical records from hospital which reveal patient admitted 11/21/06-11/22/07 after experienced rash & HTN 8 days s/p flu vax.  Exam revealed fatigue, swollen left foot, shotty cervical lymph nodes in neck, diffuse peripuric rash & torticollis.  Had mild abdominal pain.  Admitted renal consult done. Rheum consult recommended & renal f/u scheduled as outpatient. FINAL DX: Vasculitis, likely Henoch-Schonlein Purpura (HSP); nephritis; HTN. Per 60 day follow up: Dx with HENOCH-SCHONLEIN purpura doing well.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ lot #L008996, expiry date 01-DEC-2016, lot #L023870, expiry date 20-APR-2017, L008054, 30-NOV-2016, K020182, 25-JUN-2016. Temperature excursion of 52 degrees Fahrenheit for 182 days, no data logger and there was no previous excursion. There was no adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.