chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little; redness in torso and back started on the scalp; itchy; burn a little; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little). At the time of the report, ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information has provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-275407 (Patient Link).
Unspecified side effects; A spontaneous report  was received from a consumer, concerning a male patient (age unspecified) who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced unspecified side effects ( Vaccination Complications)    The patient's medical history was not provided. No relevant concomitant medications were reported.    On unspecified day in JAN-2021 (two weeks ago from the reporting date), approximately 20 hours, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 (batch number not provided) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.  On an unspecified day in JAN-2021, the patient had experienced unspecified side effects and was hospitalized.   Treatment information was not provided.  The outcome of the event unspecified side effects was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Very limited information  has been provided at this time and further information has been requested.
Information has been received from a registered pharmacist concerning a 67 year old male with no pertinent medical history and no drug reactions/allergies, who on 19-NOV-2008 was vaccinated with one dose ZOSTER vaccine via subcutaneous (lot # 662969/1206X). Concomitant therapy included therapy unspecified "FLOXAMINE", OXYBUTIN, theophylline cr and carbidopa (+) levodopa (MSD). Subsequently the patient experienced injection site reaction. The injection site was red, swollen a warm to touch. The patient sought unspecified medical attention via telephone call. No lab diagnostics studies were performed. The patient's injection site reaction was not recovered.  This is in follow-up to report(s) previously submitted on 12/23/2008.  Follow-up information was received from the Register Pharmacist on 19-DEC-2008.  The patient with no illness at the time of vaccination on 19-NOV-2008 was vaccinated the first dose of ZOSTAVAX (Merck).  On 19-NOV-2008, the patient developed redness, warmth, swelling at injection site.  On 20-NOV-2008 the patient contacted us and his MD advised to take diphenhydramine.  On 21-NOV-2008, the patient's redness, warmth and swelling at injection site were resolved.  Additional information has been registered.
unauthorized use of COVID Vaccine.  Discussed with parent, patient had fever and body aches after both vaccines. No other complaints.
Diarrhea one day after taking vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea one day after taking vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIARRHOEA (Diarrhea one day after taking vaccine). At the time of the report, DIARRHOEA (Diarrhea one day after taking vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Developed eczema within 2 weeks of receiving vaccines.  Treated with lotions and creams but still occasionally comes back.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions or allergies were not specified. On 15-SEP-2014, the patient received an expired dose of PNEUMOVAX23 lot number H021941, expiration date 11-JUL-2014, dose 0.5 ml, intramuscular. No symptoms were reported. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine in the afternoon.  Woke up in the middle of the night - had chills, aches, tired, heart was pounding. Went to the ER - they did EKG, labs. They had to do a stress test the next AM. Had to see a cardiologist. Started 3 different medications: diltiazem, (cannot remember the other 2)
Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The office staff member reported that a dose of Kinrix given to the patient and it was already expired.  No further details provided. Consent granted for safety to follow up. The reporter consented to follow up.  Additional Supportive Information: The use of Kinrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
Period late  , just got it dec 21  Have been experiencing mild chest pains I am u sure if this is related j it it?s been going on since the vaccine
wake up this AM itching, w/fine, sl raised rash on back & stomach;tx OTC DPH;
Pt vaccinated w/FLU developed sore throat & stiff neck. Dr told pt that he'd seen 5 other people who had got flu shots (seen same day as pt).
Sore left arm Chills Body Aches Headache Fever Congestion Sinus Drainage Cough
Telephone call from client 2 wks post vaccine Var/Tdap reports generalized rash, except at vaccine administration site, x 10 days post vaccine. Pt report concurrently taking Amoxicillin. Resolved without intention.
broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.; rash in left arm near the injection site; the rash as big blotchy red areas that itch; the rash as big blotchy red areas that itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch), RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.) and VACCINATION SITE RASH (rash in left arm near the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.). In July 2021, the patient experienced RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch) and VACCINATION SITE RASH (rash in left arm near the injection site). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch) and VACCINATION SITE RASH (rash in left arm near the injection site) outcome was unknown and RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-297311 (Patient Link).
Pt with pain and swelling of the axilla that started about 12 hours after vaccine administration.
CHRONIC BRONCHITIS; DIZZINESS; DIARRHEA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included bacteria (took antibiotic) and concurrent conditions included bronchitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total administered on 04-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included azithromycin, and fexofenadine hydrochloride/pseudoephedrine hydrochloride.  On 06-APR-2021, the patient experienced coughing, chills, hard to breathe. On 06-APR-2021, the patient experienced vomiting and had more coughing. Patient started coughing blood and called the insurance company for an urgent care. On 01-MAY-2021, patient diagnosed with chronic bronchitis and started on Zpak and prescribed Allegra D.  The patient recovered from vomiting, had not recovered from dizziness, diarrhea, and headache, and the outcome of chronic bronchitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210505177-covid-19 vaccine ad26.cov2.s-chronic bronchitis. 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: MEDICAL HISTORY
got vaccinated for covid and rheumatoid arthritis came back hundred percent; pain on hips; bone on bone; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4533445-00 (Company).  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "got vaccinated for covid and rheumatoid arthritis came back hundred percent"; ARTHRALGIA (non-serious), outcome "not recovered", described as "pain on hips"; OSTEOARTHRITIS (non-serious), outcome "unknown", described as "bone on bone". The action taken for adalimumab was unknown. Clinical course: Consumer of an adult female with events of non-serious bone on bone, got vaccinated for Covid and rheumatoid arthritis came back hundred percent and pain on hips with Humira (Adalimumab). There was no reported medical history. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of bone on bone, got vaccinated for Covid and Rheumatoid arthritis came back hundred percent and pain on hips was not reported.  The reporter's assessment of the causal relationship of "got vaccinated for covid and rheumatoid arthritis came back hundred percent", "pain on hips" and "bone on bone" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  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 information in the case report, a possible causal relationship between the reported events: "Rheumatoid arthritis", "Arthralgia", "Osteoarthritis" and the suspect drug BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
AFter recieving the pentacel in his left arm at the health dept on monday 2/23/2009, he developed left arm significant swelling, redness, and pain. Family did give him some tylenol and motrin and applied ice. I saw him today for his physical. The left arm swelling was much improved but was still existant. he was able to move his arm well and without any difficulty. pulses 2+ x 4. sensation intact.
INJECTION SITE PAIN; BLOOD IN URINE; ARM REDNESS; This spontaneous report received from a pharmacist concerned a 50 year old female. 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: 1805031, expiry: 26-MAY-2021) 0.5 ml, administered on left arm on 15-MAR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced blood in urine. On MAR-2021, the subject experienced arm redness. On 15-MAR-2021, the subject experienced injection site pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc oxide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood in urine, and the outcome of injection site pain and arm redness was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Arm became very sore @ the site, unable to lift arm felt numb, chills but no temp,Diff breathing.  Took OTC Benedryl 50 mg, Provocet 600/100, turned O2 up to 9.5L on CPAP & covered up.  Lasted until 11 PM 10/19/2009.  Weak the next AM but felt better.
Beginning about 24 hours after shot headache, chilling, and nausea off and on for first couple of weeks.   Beginning about May 9 began with severe abdominal pain, chilling, and general not feeling well.,  Then on May 13th noticed start of rash.  Saw doctor on 14th and diagnosed with Shingles.  Treated with valacyclovir for 7 days.  At present still have rash, severe pain, chilling, and nausea with decreased appetite.
No Adverse reaction was seen.  The patients father made an appointment for everyone in the family to get a covid booster dose, although we didn't know this at the time. When the child came in, on the system it stated the child was at our clinic to receive his 2nd Primary Series Monovalent vaccination. I confirmed that with the child and the mother as she was walking by. After I vaccinated the child, the father comes up to me and ask when his son can come back for the other booster dose. I then asked the father to clarify to me his statement. He said that his son was here today to get his booster dose. At that point I realized that the child had been given the wrong vaccination. I went to get our site supervisor to inform her of what I just found out. Once I explained to the father that the son handed me his v-card and that it only had one covid vaccine dose on it, I then explained to the father that the child can come back in two months to receive his Bivalent Booster dose and explained the CDC guidelines of the Monovalent and Bivalent vaccinations. The father then said, ok, thank you and the family left.
Took first oral vaccine dose 2.5 hours after a meal, before bed, with large glass of water. 10 hours later, started having continuous abdominal pain with painful cramping, 4/10 to 5/10 on the pain scale. Transient episodes of nausea, no diarrhea, no abdominal distention. Abrupt onset of fatigue, slept 5 hours (after good night's sleep) on and off with abdominal pain the entire time. Gradually, pain became on and off and cramping less. Recovered and resolved 6 to 7 hours after it began.
At 1 am - 11 hours after vaccine; Felt dizzy and lightheadedness. She passed out for a few seconds, laid down, very dizzy, tinnitus. 3am to 10 am  Pulse rate is high 120-150 Tired and weak on Sunday, but heart rate returned to normal again.
the patient developed a localized rash with no bumps at an unspecified location; the patient also developed a fever that reached up to 103.9F; This spontaneous report was received from a nurse practitioner via a company representative, concerning to her daughter, a 12 month old female patient. The patient had not pertinent medical history, concomitant medications, drug reactions or allergies. Information regarding the patient's pertinent concurrent conditions was not provided.  On 03-MAY-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026362, expiration date reported as 31-MAR-2020, but upon internal review validation established as 15-MAR-2020, subcutaneously (strength and anatomical location were not provided) for prophylaxis. On 10-MAY-2019, the patient experienced a localized rash with no bumps at an unspecified location and also a fever that reached up to 103.9 fahrenheit (pyrexia). On 12-MAY-2019, reported as two days later, the patient recovered from the event pyrexia. It was reported that no medical attention was sought for the events and no laboratory diagnostic studies were performed. It was unknown whether the patient received treatment for the events.   The outcome of rash was reported as resolved on an unknown date in May 2019. The causality between the events and therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Diffuse proximal muscle aches. Diagnosed as Polymyalgia Rheumatica and treated with steroids with marked improvement.
103 to 104 fever/high fever; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe headache) 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 13-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe headache). At the time of the report, PYREXIA (103 to 104 fever/high fever) and HEADACHE (Severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 103 to 104.         No relevant concomitant medications were reported.  No treatment information was reported.
20 mins after vaccine, patient had SOB, tachycardia. No local redness or inflammation at site. Sat with head between knees, ambulance called. Felt better once ambulance got there. 10 min after standing up, experienced same symptoms but worse. Sat with head between knees & went with ambulance upon re-arrival. Patient returned to pharmacy that night to say he was ok.
10 days /p vax devel gen erythematous maculopapular rash w/ some vesicles;lesions on trunk,face,mouth,lips&extremities;pt to MD for checkup on 10jul95;extensive mature crusted lesions, many deep ulcerations;MD concern for scarring formation
Wrong dose was given to pt. Pt is a 10 year old and received a 12+ year old primary Moderna vaccine. No adverse S/S noted at time of administration.
Severe Hypertensive crisis. My blood pressure shot up to 240/184 mmHg for the next 24 hours or so until it gradually came down over the course of a few days. I am very healthy as fitness and health is a big part of my life. I was also taking my blood pressure almost every day leading up to the vaccine because I was learning about the circulatory system and applying my own body to my studies to learn better. The extremely dangerous spike in my BP could have killed me. It can be drawn back to nothing else but the vaccine.
Redness and itchiness; Redness and itchiness; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness and itchiness), PRURITUS (Redness and itchiness) and delayed reaction to the vaccine. At the time of the report, ERYTHEMA (Redness and itchiness) and PRURITUS (Redness and itchiness)  delayed to the vaccine utcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The vaccine given was expired. This vaccine was drawn up yesterday 8/10/21 morning and the vaccine was given more than 24 hours after it was reconstituted.