chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching; bottom lip was swollen; This is a spontaneous report from a contactable consumer via the Medical Information Team. An 85-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date at a single dose for an unspecified indication. Medical history included hard of hearing. The patient's concomitant medications were not reported. It was reported that the patient started itching and bottom lip was swollen. Bottom lip swelling has gone down today but she has still itching all over the body. She tried Benadryl but not helping. The outcome of the event itching was not recovered while recovering for the other event. Information about Lot/Batch has been requested.
No side effects in 30 minute waiting period and none on day of injection--some mild itching began night of injection. Day after, Saturday, itching intensified, throat tightened (muscular feeling); and tongue began to become sore, and began to show redness on sides.  Bad enough that I finally took a 4-6 hour dose of Benadryl, and slept afternoon.  Felt better when I woke up but when effects of Benadryl wore off, the tongue swelling intensified and frightened me.  Decided against emergency call on weekend and took Benadryl (4-6 hour) about 8 or 9 Pm and next morning (about 5 or 6AM) noted that I felt okay and tongue had become pink not red though still some swelling on the sides of tongue.  Had no strong adverse effects after first dose, some chills in the evening and arm swelling/pain  that resolved by 3AM.
Days 1, 2, 3 - left upper arm - injection site warm, red circular area about 2 inches in diameter, extremely painful Day 11 - left upper arm - injection site reappeared as warm, rectangular pink area about 3 inches x 2 inches, with slight muscle soreness, but pain not to the extent of days 1, 2, and 3
Patient received 1st dose on 1/31/2022.  Second dose received on 2/15/2022, only 16 days after 1st dose.
pt recvd vax & devel fever w/ t 105; vomiting; sore throat;
Initial report received on 08May06 from an investigator participating in the above mentioned trial. A six month old female subject experienced failure to thrive and chronic diarrhea, 112 days after receiving an IM, right thigh, second dose injection of Influenza virus vaccine No preservative Trival A and B Subvirion U. Lot number UD07402. Sixteen days later, she was hospitalized for the event. At the time of this report the event was considered ongoing. According to investigator, the events were not related to the study vaccine. Follow up information received on 26May06. The subject's final diagnosis was autoimmune enteropathy assumed to be protein allergy. Follow up information received on 09Jun06. Per the reporter, 105 days post immunization, the subject developed otitis media, chronic diarrhea, mild dehydration and failure to thrive that lead to hospitalization on 06May06. On admission to the hospital the subject weighed 13 pounds 6 oz. A RAST test was completed and was negative for whey, wheat, soybean, peanut and egg. A barium contrast enema of the colon was normal with no abnormalities. Stool cultures for parasite, ova and bacteria were negative. Immunology/serology testing was completed and showed the immunology IGG=875 (range 211-741 mg/dl), IGG 1-750 (range 205-409), IgA 169 (range 10-50), IgM 104 (range 20-100), Celiac disease antibodies showed Gliadin ABS, IgG 74.9 (range 0.0-24.9EU) and Gliadin ABS, IGA34.9 (range 0.0-24.9EU). The HIV antibody was non reactive. Treatment for the event was not provided. The subject was started on Neocate 32-35 oz a day, with no other foods until good weight gain is obtained. The subject was discharged from the hospital on 19May06 with a discharge weight of 12 pounds 10.5 oz. The subject was discontinued from the study on 26May06. At the time of this report, the subject had not recovered from these events. The events in this case were previously reported as not related to the study vaccine, but according to the investigator, the causality has changed and is now being reported as related to the study vaccine.
Hardness in arm, extreme soreness in injection site 6 weeks out, after 2 days extreme pain in arm extending from shoulder, collar bone area to elbow,.restricted circulation ( hand, lower arm much colder than other arm)  x-ray revealed narrowing of joint in shoulder. Still painful
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the unspecified patients were vaccinated with unspecified doses of GARDASIL 9 (dose, lot number and expiration date were unknown) following a temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mom was asked if pt had h/o wheezing or allergy to eggs to which she replied "no". FLUMIST was administered. Within less than 5 min, pt had tachypnea, wheezing, hypoxia. 2 albuterol nebs were given, respiratory distress improved. Then pt developed diffuse urticaria. EPIPEN Jr, ORAPRED, BENADRYL were given & 911 called, pt taken to ER.
Nausea, diarrhea, headache and fever and next day migraine, nausea, fever and rash.
This is a spontaneous report obtained from a contactable consumer. This 55 year old female consumer received intramuscular PREVNAR 13 at 09:00 am on right arm on 21Jun2012. Relevant medical history, concomitant medication and vaccines given on the same day were none. Vaccine taken within the last four weeks was none. On 21Jun2012, at 09:30 pm while on PREVNAR 13, she had sore muscle and mild pain at the site of injection. At the time of the report, the patient had not recovered from the events.
SORE ARM; This spontaneous report received from a patient via social media via a company representative concerned a 58 year old White male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and high blood pressure, and other pre-existing medical conditions included: The patient had never tested positive for covid ever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ascorbic acid, and vitamin b complex.  On JUL-2021, the patient experienced sore arm. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on JUL-2021. This report was non-serious. This case, involving the same patient is linked to 20220210373.
Red raised rash/swelling occurred at injection sight with itching .  Rash is 2.5x3inches in size.  Still present 30 hours later with itching also occuring on neck.
Arm pain lasting 4 weeks; difficulty moving the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain lasting 4 weeks) and LIMB DISCOMFORT (difficulty moving the arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    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 PAIN IN EXTREMITY (Arm pain lasting 4 weeks) and LIMB DISCOMFORT (difficulty moving the arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain lasting 4 weeks) and LIMB DISCOMFORT (difficulty moving the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment for the event included ibuprofen (Advil )and ibuprofen (Motrin)   Reporter did not allow further contact
Heavier cramps; longer cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: ER8730) at the age of 42 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 (lot number=EN6208,, dose number=1,, vaccine_location=Left arm), administration date: 26Mar2021, when the patient was 42 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN (non-serious) with onset 01May2021, outcome "not recovered", described as "Heavier cramps"; OLIGOMENORRHOEA (non-serious) with onset 01May2021, outcome "not recovered", described as "longer cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain, oligomenorrhoea.  Additional information: No other medications the patient received within 2 weeks of vaccination. patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was tested Nasal Swab covid test result Negative.   No follow-up attempts are possible. No further information is expected.
A non-serious report of expired dose of vaccine administered has been received from a healthcare professional concerning a six-year-old male patient.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 29-Jan-2008.  The FluMist had expired on 10-Jan-2008.  At the time of the report, no adverse events were reported from this error.  Rechallenge is not applicable.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Pt has redness, inflammation in the area of the injection site.  Injection site is hot to the touch, pt states area is very sore and tender.
01/27/22 presents to surgery for "Lap assisted vaginal hysterectomy". PMHx of "hypertension" "COPD" "diabetes" "hypothyroidism"
Delayed 2nd Moderna vaccine administration; diarrhea; Over 100F high fever; Vomiting; extreme fatigue; Nausea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048S21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (Over 100F high fever), VOMITING (Vomiting), FATIGUE (extreme fatigue) and NAUSEA (Nausea). On 20-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. In 2021, PYREXIA (Over 100F high fever) and FATIGUE (extreme fatigue) had resolved. On 20-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Delayed 2nd Moderna vaccine administration) had resolved. At the time of the report, DIARRHOEA (diarrhea), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-276490 (Patient Link).
Patient had redness and flushing around the neck and sweaty palms.  Patient reported pain in left eye and left forehead above the eye.   The patient reported feeling ?out of sorts?  with a tingling or numbness from her shoulder to her neck and tingling in the left side of her face.   She felt light headed when standing  and her feet hurt.   She was given diphenhydramine 25 mg and observed for an hour and a half at which time she reported feeling better .  Her temperature was 97.5 F at 13:23 and 97.9 at 13:45. She left work early and went to the walk-in clinic later that evening. She reported that the clinic said all of he vital signs were normal and they did not note any specific problems. She took second diphenhydramine 25 mg. She was contacted at around 8:30 AM on 1/6/2021 and reported that she was feeling better.
Patient received the Covid-19 vaccine. She reports symptoms of flushing, swollen feeling in throat with some difficulty swallowing. No difficulty breathing, no wheezing, etc. Symptoms quickly lessened in intensity with first set of vitals. Injection was given at 1443.  I have observed patient from immunization given through 1605.  Treatment/intervention  1500:  BP  138/90  Pulse 94  SPO2 98% Respirations 20 Diphenhydramine 25 mg given - patient requests to receive.   1502: BP  128/90  Pulse 100 SPO2 96%  1506: BP  126/88  Pulse 96 SPO2 99% Respirations 16   Patient tolerated 8 oz water, swallowing  Without difficulty, still feels strange feeling in throat but much improved.   1510:  Patient states she is feeling "much better" and has called spouse for ride home. 1525: 2nd dose of Benadryl 25 mg given.  Patient is feeling much better, throat swelling sensation decreased, face is pink, not flushed, swallowing well and tolerated second 8 oz water.   Instructed to contact physician regarding reaction today.  Instructed to call 911 if any symptoms recur, difficulties breathing, etc. 1605:  Escorted to husbands car, states feels "good."
Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 14 days past expiration.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # K004542 and expiration date 19-AUG-2015 (route and dose not reported). On an unknown date, 24 to 48 hours after being administered PNEUMOVAX 23, the patient experienced hot and painful injection site reaction. The patient sought medical attention and was diagnosed with cellulitis at the injection site. At the time of the report the outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
MOM REPORTS 104 DEGREE FEVER FOR 3 DAYS AND A RASH (HIVES?) FOR 1 TO 2 DAYS.
shortly after receiving the vaccine, as patient was leaving, she told her mother, she was going to pass out - then she passed out and fell to the floor. a cool pack was applied and juice given.
But now he has a problem with his right shoulder; First dose on 04 Nov 2021, second dose on 04 Mar 2022; Sore right arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder), PAIN IN EXTREMITY (Sore right arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022) in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 030A21A and 048C21A) for COVID-19 vaccination.     No allergies to medications, food and other products was reported.  Patient was not diagnosed or tested positive for COVID-19.  No history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022). In 2022, the patient experienced PAIN IN EXTREMITY (Sore right arm). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder) had not resolved, PAIN IN EXTREMITY (Sore right arm) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022) outcome was unknown.            Patient had taken booster dose of Moderna on 03 Feb 2022 (batch no. 007M20A). Booster dose administered before second dose.  Patient took Tylenol for the pain which improved symptoms a little bit.   This case was linked to MOD-2022-629044, MOD-2022-629049 (Patient Link).
LOSS OF SMELL; This spontaneous report received from a patient concerned a 44 year old male. The patient's weight was 165 pounds, and height was 70 inches. The patient's concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had No known allergies, no drug abuse or illicit drug usage and patient did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 18-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-AUG-2021, the patient experienced loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of smell. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dsoe 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "slightly overweight" (unspecified if ongoing); "Tree nuts allergy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Sep2023 to 24Sep2023 .  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315563 Same patient, different drug/AE.;
Patient's arm turned red from elbow to shoulder and was hot to touch within hours of receiving immunization.
Child received vaccines on 6/12/13. Mother called back after office had closed -stating child had "seizure-like activity" and called EMS. Did not take child to ED. Only had eval by EMS. Pt was unresponsive 10-15 min, when activity happened. Eval by FNP 6d later. Awaiting peds neurology referral for further eval.
2.5 in x 2 in erythematous circle surrounding vaccine site. Not painful to touch, mild warmth, itchy.
Given vaccine Tues aft. Weds 1am-T 104 degrees, 7am vomited T102, vomiting, lethargy-8pm. ER WBC 17K received IV Rocephin BC and UC done.
severe diarrhea,  everything tasted salty and metalic,  heart skipped beats extreme brain fog, weakness and fatigue
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown date in 2016 (reported as "unspecified dates since 29-SEP-2016"), the patients were vaccinated with doses of improperly stored M-M-R II albumin status of rHA, lot # L040961, expiration date 19-NOV-2017 (dose and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Difficulty breathing; Fast heart beat; Dizziness; Diarrhea; Vomiting; Arm pain; Nausea; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 26May2021 at 10:00 (at the age of 73-year-old), as dose 1, single in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 at 11:00, the patient experienced difficulty breathing, fast heart beat, dizziness, diarrhea, vomiting, arm pain and nausea. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab test and procedure which included heart rate: fast, on 26May2021 at 11:00. The clinical outcome of all the events was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-AUG-2016. On 12-OCT-2016, the patient was vaccinated with an improperly stored PROQUAD, lot # M019233 with expiration date of 17-OCT-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 15 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA013888:
Pt experienced a local reaction at site of injection, with a 2 cm area of erythema, warmth on right thigh. Mother advised to use ice on area with diphenhydramine.