chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm body; Bone pain; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE WARMTH (Warm body), BONE PAIN (Bone pain), HEADACHE (Headache) and MYALGIA (Body aches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 01102QA) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), GLIPIZIDE, SIMVASTATIN, ALENDRONATE SODIUM (ALENDRONATE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced INFUSION SITE WARMTH (Warm body), BONE PAIN (Bone pain), HEADACHE (Headache) and MYALGIA (Body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency and OSELTAMIVIR at an unspecified dose and frequency. At the time of the report, INFUSION SITE WARMTH (Warm body), BONE PAIN (Bone pain), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
I tested positive for COVID today; I tested positive for COVID today; This is a spontaneous report from a contactable other Health Care Professional (HCP).  A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 24Dec2020 (at an unknown age) at an unknown dose for COVID-19 vaccination.  The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID on 01Jan2021. The patient was inquiring as to if she can still get the second dose since she has tested positive in between. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 01Jan2021. The clinical outcome of COVID-19 virus test positive was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
mom reported pt did not feel well;p/vax started feeling sick, couldn't hold head up started shaking, dropped books on floor;couldn't walk straight, running into walls;very pale, h/a & stiff neck;
pt recv vax & 3-4hr p/vax pt became very ill w/o h/a & felt extremely fatigued;pt states also devel a fever but did not take temp;also reported that arm became very reddened, inflamed & tender & knot devel @ upper lt arm extended to elbow
Approximately 5 minutes after receiving a Hepatitis A vaccine this patient c/o to her mother of immediate pain at the injection site, nausea and weakness- nurse was alerted and observed the patient's color becoming pale, she was then assisted to the ground. No loss of consciousness- VS monitored and stable throughout, gave juice and felt better, observed by nursing for approximately 15 minutes- patient was discharged in stable condition-repeat vital signs stable- left ambulatory and fully oriented with her mother and sister accompanied by nursing staff.
Pt reports that she developed perioral itching and swelling as well as mild swelling and itching of the tongue beginning approx 30 min after vaccination when she was already en route to work. She reports that she's been taking Benadryl around the clock but as of 3/31 symptoms were still persisting when she sought care. Pt denies ever having difficulty breathing or swallowing during this time.
Hospitalized from 2/5/04-2/9/04, with pneumonia. Blood culture and for streptococcus pneumoniae. The discharge summary states bilateral otitis media and new onset seizures.
Client c/o mild dizziness and lightheaded while seated and tingling/numbness in left hand; PHN noted  red rash on chest area and both arms flushed.  PHN monitored client's VS @ 11:30-B/P 156/92 (RA); HR 92; RR 16; Temp. 96.0F; O2 Sat. 96-98%; per client request; Benadryl 50 mg cap taken by mouth; PHN instructed medication could possibly cause drowsiness, blurred vision, dry mouth, nose, and throat; advised to drink lots of water; @11:55, PHN noted rash diminishing is size and color; arms less flushed; B/P 133/82 (LA); HR 77, RR 16, O2 Sat. 96%; client reports dizziness, lightheadedness and  tingling/numbness in left hand resolved. PHN  reminded the client that Benadryl can cause drowsiness and reiterated the importance of drinking lots of water. Client stated she only lived 5 minutes away from the clinic and she was driving straight home. Client's condition appears stable at time of departure.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Went to the Internist and had the kind of rash all over body; This is a spontaneous report from a contactable nurse (reported for her girlfriend). A female patient of an unspecified age received BNT162B (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient went to the Internist and had the kind of rash all over body. The outcome of the event was unknown.  Information on the lot/batch number has been requested
mom brought pt to hosp due to fever c/o muscle aches & erythematous area approx 10cm lt elebow t104.6 oral; c/o muscular aches; MD was notified & pt was sent to ER; (erythema is not @ inject site);
Pt called pharmacy on 10-27-13 to ask if using an ice pack on the swollen rash from her vaccines. The rash started on the evening of 10-25-13. The patient used ibuprofen and an ice pack. By 10-28-13 the rash was much better. MD not called. She was OK with the improvement.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in a 13-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    No concomitant medication was reported.  It was reported that patient 9 didn't report any adverse events. No treatment medication was reported. This case is reported for patient 9 out of 12 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:master case
Information has been received from a registered nurse concerning her approximately 1 day old son with many unspecified allergies and no previous medical history reported, who "the day after birth", on 30-DEC-1998 was vaccinated with the first dose of RECOMBIVAX HB along with the other routine vaccines. Then a month later, on approximately 30-JAN-1999, the patient received the second dose of RECOMBIVAX HB and then received the third dose, two months later, on approximately 20-MAR-1999 and after each dose the patient started to get worse. Then after many different test's, the patient was diagnosed with a muscle disorder called hypotania, and has been going through therapy to help his condition. The mother reported that the patient has been doing better because of therapy. On unspecified date, the patient had various tests done (unspecified and results not provided). The patient sought physician's medical attention. No further information is available.
This case was reported by a other health professional via call center representative and described the occurrence of chest tightness in a 11-year-old patient who received BEXSERO. On 22 August 2016, the patient received BEXSERO. On 22nd August 2016, less than a day after receiving BEXSERO, the patient experienced chest tightness, crying and headache. The patient was treated with oxygen. On an unknown date, the outcome of the chest tightness, crying and headache were unknown. It was unknown if the reporter considered the chest tightness, crying and headache to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The reporter was administering oxygen to the patient when contacted to report the adverse event and requested to be connected with Medical Information. No additional information was available at time of reporting.
GOLF BALL SIZE INFLAMMED AREA /RED SWOLLEN / AT INJECTION SITE.
Exhausted, no energy, heart rate climbed to over 100 until I took an aspirin.  103 104 103 while sitting in my easy chair. Tightness in my chest, so I took the aspirin. Finally subsided but scared me.
Bilateral eye swelling; Upper lip swelling; Left ear itchiness; This is a spontaneous report from a contactable nurse, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 23Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergy to NSAIDs, crab and shrimp. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received acetylsalicylic acid (ASPIRIN) and ibuprofen (MANUFACTURER UNKNOWN); both for unknown indication on unknown date and experienced drug allergy. On 23Apr2021 at 15:30, the patient experienced, bilateral eye swelling, upper lip swelling and left ear itchiness. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with dexamethasone (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bilateral eye swelling, upper lip swelling and left ear itchiness was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. On an unknown date in 2014, reported as since 14-OCT-2014, the unknown number of patients were vaccinated with GARDASIL (dose, route, lot# and expiration dates were not provided) that had been improperly stored. No concomitant medications were reported. No adverse effects reported. This is one of the several report received from the same reporter. Additional information has been requested.
cough is a lot worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 27Dec2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had a cough yesterday", start date: 26Dec2022 (ongoing), notes: Calling about the Pfizer COVID shot, had a cough yesterday. The patient's concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "cough is a lot worse".  Additional information: It was reported that, calling about the Pfizer COVID shot, had a cough yesterday and then got the shot this morning at 10 and now cough is a lot worse. Has test kits, would the test kit give a false positive since caller had the shot this morning. Not related to a study or programme.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Erythema; swelling about one week after injection.; Felt hot; some fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GN1897, Expiration Date: 31Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown"; SWELLING (non-serious), outcome "unknown", described as "swelling about one week after injection."; FEELING HOT (non-serious), outcome "unknown", described as "Felt hot"; FATIGUE (non-serious), outcome "unknown", described as "some fatigue". Therapeutic measures were taken as a result of erythema, swelling, feeling hot, fatigue.  Additional information: One description from the doctor (for one of the patients) Erythema, swelling about one week after injection. No fevers or chills, no drainage, no sore. Felt hot, generalized swelling, well demarcated irregular area, no respiratory symptoms. some fatigue. The caller stated but she took Benadryl so she is guessing that is the fatigue thing.
Hospitalized for dyspnea, substernal chest discomfort and new hypoxia.
Severe hive like rash on face that spread to chest and back area that is extremely itchy.
flu like symptoms/side effects; side effects; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (1st dose received on unknown date. Please refer the case US2020092721).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and adverse drug reaction. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms and adverse drug reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The patient had not elaborated beyond the flu like symptoms. the caller did not wish to participate in a safety report and would not elaborated on flu like symptoms, or other side effects. The reporter did not consent to follow up.   Follow up information received from consumer on 25th June 2020: The patient's flu-like symptoms lasted approximately 48 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092721:
Rash/hives on face and arm. Had rash on face starting 4/13. Arm rash showed up 4/15 and is getting larger as of 4/16. Contacted doctor in regards and can not be seen. Will make an appointment on Monday if rash has not subsided.
I have an employee who works in the Surgery center in an office by herself with no patient contact. Vaccinated with 1st Varicella vaccine of the series due to low immunity, level 0.78 on 4/10/18. Reports low grade fever 99.8 begun Sunday night 4/22/18. Reported to work on Monday, went straight to closed door office right off the front entrance of Surgery, worked 8-9 hrs yesterday and only came out to use the rest room. Otherwise remained in closed office from visitors and staff. Monday night, noticed sporadic red spots on face, arms, neck, and thighs. No clustering, no open lesions but itchy. Called off today, fever 100.0, contacted PCP, they explained the potential of rash, fever post vaccination. Called me, Recommendation/policy, must be fever free for 24 hrs without fever-reducer, and lesions must be dry and crusted. Informed she will need to call me to set up RTW prior to reporting back. Employee is able to work from home, if Leader approves. Treatment recommendation conservative, fever reducer, AVEENO bath for itch. Adverse risk.
12:17 felt heart racing, face flushes, SOB with speaking. States she feels like she is going to pass out. Taken to private observation via w/c area with EMT on site in attendance. BP 180/120; HR 100; 02 99% on room air..  States she also feels lightheaded, is having generalized shaking, especially hands trembling.  No redness or swelling noted at injection site. States she did eat yogurt and granola bar at 10 am.  12:29 - drank about 2 oz water without difficulty. Denies itching, states she feels better, but is still shaking vigorously all over upper body. Denies being cold. Denies chest pain. just feels like she can't catch her breath. Still flushed in cheeks and forehead.  12:34 BP 158/100; HR 82; O2 96% on r/a. Still shaking. Covered with her sweater. 12:36 Doesn't feel like she is going to pass out anymore. Still having tremors, shaking. Unable to completely catch her breath 12:40  EMS activated.  12:42 HR 77; O2 99% on r/a . Still shaking. States Bactrim sometimes sends her sideways. States she does have a history of hypoglycemic events.  12:55  arrived. Patient still shaking and feels lightheaded again.  12:58 BP 168/90; HR 91; O2 98% r/a. POC glucose check per EMT - glucose - 85  Gave patient juice 1306 Shaking subsided. She thinks the juice helped. BP 156/86; HR 78: 99% r/a 13:07 released patient she states her SOB is gone. No more tremors. Denies lightheadedness.  13:13 Patient taken to private vehicle driven by husband.
No additional AEs were reported; A veterinarian calling for herself to report AE. She reported that she received GARDASIL 9 vaccinations on the following dates: 06/02/2022, 06/23/2022, and 02/16/2023.; This spontaneous report was received from a veterinarian calling for herself, a patient ofunknown age (female). There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  She was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis on 02-JUN-2022, 23-JUN-2022 and 16-FEB-2023 (Inappropriate schedule of product administration). No additional adverse events were reported.
9 hrs after second dose, around 7pm on 2/1, the skin on my back began hurting. Within an hour, i had severe joint pain in my hips and my backbone hurt up into my neck.  For the next 10-11 hours every inch of my body was in severe pain. It was excruciating. My bones felt fractured. I could barely walk to the bathroom. I couldnt push myself upright in bed to take tylenol. My husband had to pull me up and hold the glass of water for me to drink. I ran a high fever for several hours, around 101, and I truly thought i might die. By 9 am the following day, 2/2,  i began to feel better. I could walk slowly without much difficulty and fever was gone. The next day, 2/3, i went back to work but still had hip pain and neck pain. That day around 4 pm, all side effects were completely gone and I had alot of energy. I do have pain on left side of my head periodically but it isnt bad.
Pt got Bivalent dose instead of primary dose. Pt was informed and he was asked to call back if he had any side effects. He was instructed on most common side effects.
02/13/14-Seen for eczema flair and diagnosed with intolerance of Protopic. 02/18/14-Irritability reported by phone-? of side effect of Rotateq. 02/21/14-Seen for colic-like symptoms. 03/03/14-Seen for history of seizure like episodes; ref to neurologist. 03/04/14-Diagnosed by neurologist with infantile spasms.