chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm to touch; Injection site turned into a bump; Arm itching; Extremely swollen; Red circle; Arm started to get sore; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Arm started to get sore) and VACCINATION SITE SWELLING (Extremely swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (Headache). On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (Arm started to get sore). On 09-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle). On 01-Jan-2021, VACCINATION SITE PAIN (Arm started to get sore) and HEADACHE (Headache) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PAPULE (Injection site turned into a bump), VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE SWELLING (Extremely swollen) and VACCINATION SITE ERYTHEMA (Red circle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications included Paracetamol and Ibuprofen for headache which helped. She took Diphenhydramine and Cetirizine and put some ice for swelling and itching. She was not sure if this helped.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial information received from other healthcare professional on 15 Dec 2009: The caller stated that the patient may have received a second dose of S-OIV FLUVIRIN. The caller stated that the patient believed that he received vaccine "one month ago" but was unsure if it was H1N1 or seasonal. No adverse event was reported. No other information was provided.
This case was reported by a physician via call center representative and described the occurrence of lethargy in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 28th August 2018, 1 days after receiving SHINGRIX, the patient experienced lethargy, injection site erythema, fever and injection site swelling. The patient was treated with BENADRYL. On an unknown date, the outcome of the lethargy, injection site erythema, fever and injection site swelling were recovering/resolving. It was unknown if the reporter considered the lethargy, injection site erythema, fever and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The patient received SHINGRIX vaccine in the left deltoid. The physician stated that the patient woke up on the date of reporting with lethargy, 3 to 4 inch erythema at injection site, fever of 101.4 degree, and swelling at the injection site. The physician gave the patient BENADRYL and her fever went down to 100 degrees in the past hour, on the time of reporting. No further details were provided by the reporter.
Case number PHEH2015US019680 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 34 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
I had the third dose on  Sept. 23 and I am still experiencing pain at the injection sight and I have pain that travels down my arm all the way to my thumb. I have never had this pain before and I didn't have any reaction to the first 2 shots.
pain at the injection site and the muscle; pain at the injection site and the muscle; Any time I try to move it in any way, I very much feel it, the pain; Information was received from a registered nurse referring to a 39 years old female patient. The patient was not pregnant. The patient had none concomitant medication, pertinent medical history or drug reactions/allergies.  Approximately 10-15 years ago, the patient received the full quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) series (frequency, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis. On 17-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (first dose, lot number S008154 and expiration date 20-NOV-2021; frequency and anatomical location were unknown) intramuscularly for prevention.  On the same date, the patient had been having continuous pain at the injection site since then and the muscle. Any time she tried to move it in any way, she very much felt the pain. The patient had been taking ibuprofen daily, which helped with the pain.  No product quality complaint (PQC) was involved. No labs diagnostics/studies were performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The causality assessment was not provided.
Received shot 3/6/15, by March 8th fever 101 degrees arm swollen and red. Tuesday 3/10/15 went to urgent care. Told I had cellulitis given antibiotics for 10 days. Clindamycin 4 times a day.
After vacccine was given patient started complaining about minor tingling in her vaccinated left arm.
Information has been received from a "26 year old" female with penicillin allergy and no pertinent medical history who in March or April 2009 was vaccinated with a first dose of GARDASIL (injection, lot# not reported). There was no concomitant medication. The caller reported that she received her third dose of GARDASIL on 15-SEP-2009 and on 16-SEP-2009 woke up and her spine was hurting, and she also started experiencing chills. She was feeling so bad she could not drive. She thought it might be the flu as well. She did not have any experiences with the first dose of GARDASIL, and with the second dose of GARDASIL she experienced a mild pain at the injection site. No diagnostic study was performed. The patient sought medical attention through a telephone call to the office. At the time of the report, the patient had not recovered. No further information is available.
Swollen and tender and warm to touch right arm where shot site , sore arm pit, was told to take  Advil, and ice  off and on and sleep on opposite side (left side) if I develop fever or red rash to go back to dr
increased SOB; legs much more swollen; feeling bad; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (74, units not provided) received bnt162b2 (PFIZER-BINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included multiple back surgeries in the past and leukemia, lymphoedema of legs (in treatment now). The patient's concomitant medications were not reported. The patient reported that post 1st dose of vaccine, she had pretty terrible reaction, feeling bad, wanted to go to bed, legs much more swollen and increased shortness of breath. The patient stated that shortness of breath was common for her. The patient stated that her legs always swell after surgeries. The patient stated that she heard that 2nd dose was worse for symptoms. She stated that other say it was much more painful. The patient asked if she should get the 2nd dose, or will her symptoms be worse and asked why the 2nd dose was worse/what causes it to be worse. The patient asked if she should wait to get 2nd dose so that the vaccine will decrease in her symptom to prevent side effects for the 2nd dose. The clinical outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Arm vaccine administered in was sore, swollen, with redness at the site of injection about the size of a half dollar.  Site very warm to touch with firmness on both the injection site and bicep.  Also experienced chills and pain at site.  Physician felt that patient was experiencing a mild cellulitis at the injection site.  Physician prescribed antibiotic.
8 month 23 day old baby was administered a 3rd dose of  rotarix by mistake/error. There were NO REACTIONS OR ADVERSE EVENTS.
fatigue Narrative:  Patient with recent bile duct sent placement with confounding vomiting and fatigue after return from acute hospitalization
I do not know which brand of Tdap and meningococcal vaccine the patient received. The patient and her father report starting with an itchy, raised red rash a couple hours after receiving the vaccinations which progressed over the subsequent 24 hours. She was examined the following day at Urgent Care.  They noted a diffuse red papular rash with pustules and vesicles. She was treated with prednisone 30mg. She was seen the next morning (7/29/17) at Clinic and examined by Dr.  The famiy noted slightly less itch, but continued rash. They denied all other symptoms. She again was noted to have a diffuse red papular rash with pustules and vesicles. I have ordered a urinalysis with microscopy, CBC and CMP.  I increased her prednisone dose to 30mg BID to taper.  She will follow up in 2 days with her PCP, Dr.
shaky; dizziness; confusion; could not eat for couple of days; missed three days at work; fever; nauseated; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (shaky), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), DECREASED APPETITE (could not eat for couple of days) and IMPAIRED WORK ABILITY (missed three days at work) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NERVOUSNESS (shaky), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), DECREASED APPETITE (could not eat for couple of days), IMPAIRED WORK ABILITY (missed three days at work), PYREXIA (fever), NAUSEA (nauseated), HEADACHE (headache) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NERVOUSNESS (shaky), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), DECREASED APPETITE (could not eat for couple of days), IMPAIRED WORK ABILITY (missed three days at work), PYREXIA (fever), NAUSEA (nauseated), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-041085 (Patient Link).
t104 R 30-38 hrs p/vax; crying all the time mom described as not usual cry high pitched; jerked arms & feet one time; taken to ER-fussy;
Eczema- brought on by varicella. History of dry skin. Doctor does not think probably brought on by the vaccine. Positive family history eczema/psoriasis older sister.
Chart entry dated 8/31/2011: Patient received MMR on 8/18/2011 - was doing well until several days ago, developed cough, coryza, no conjunctivitis, last night developed a diffuse rash - non itchy, non febrile. Has been taking PO and activity levels good. Skin is morbilliform rash blanching over face and trunk and extremities. Assessment: measles uncomplicated clearly exanthem - wild type V exuberant immune response.
After the first and second shots I was sore and tired, which I expected. Later, however, in August 2021 I noticed my resting heart rate seemed to be higher than normal and on my job as a volunteer firefighter there were rare occasions when I felt like I might not be able to go on and that my heart couldn't keep up (it didn't come to a medical emergency, and I was able to rest and feel better). Although these calls were particularly fatiguing incidents for everyone and it's to be expected that I'd feel awful with the smoke and exertion, I don't remember ever feeling like that in any other instance. In addition, in my EMT class when we would have our pulse rates taken constantly so others could practice, mine was consistently in the high 80s at best to low 100s at its worst. None of that was normal for me a year ago or before my shots. My only guess is that I either screwed something up through firefighting, I'm having side effects from the shot, or a combination of both. I feel totally and completely fine otherwise. It hasn't slowed me down or caused pain, I just have noticed an increased heart rate which isn't normal but does not seem to negatively affect me or my abilities.
Patient got really big bruise around injection site - after 10 days still she has almost 6 inches long bruise on her left upper arm. It does hurt her to touch.
Redness; Itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash). The patient was treated with GLYCYRRHIZA GLABRA, OLEA EUROPAEA OIL, PRUNUS DULCIS OIL (BABY LOTION) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
went to have my second vaccination and she hit my shoulder blade, right at the bone; cannot move my right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the shoulder blade, administration date 30Mar2021 (Lot number: ER8733) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Mar2021, outcome "unknown", described as "went to have my second vaccination and she hit my shoulder blade, right at the bone"; MOVEMENT DISORDER (non-serious) with onset 30Mar2021, outcome "unknown", described as "cannot move my right arm". Additional information: The patient went to have her second vaccination and she (who administered the vaccine) hit her shoulder blade, right at the bone. She cannot move her right arm. The patient asked whether she should go back and get another shot. She did not take any treatment.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 4 year old male pt with no medical history, allergies, or concurrent medication who on 06Jul00 was vaccinated with a first dose of varicella virus vaccine live. On 08Dec02 the pt developed a maculopapular vesicular rash with 20 lesions on trunk and face. The child had recently been exposed to chickenpox on 25Nov02. It was reported that a swab specimen was placed in viral media and submitted to the VZV ID program on 10Dec02. Preliminary PCR results were positive. VZV strain identification showed Wild Type on 23Dec02. At the time of this report the pt was 4 years old. The nurse also reported on the pt's brother who developed a chickenpox rash. this is an amended report. The narrative now reads "The child was recently exposed to sibling who had been vaccinated with varicella virus vaccine live on 11/21/02 and developed a rash on 11/24/02" instead of "The child had recently been exposed to chickenpox on 11/25/02." No further information is required. This is a corrected report as amended.
Initial unsolicited report received from a non-healthcare professional on 9 October 2014. This case is linked to the case 2014SA141512 (Same product, same lot number and same reporter). A patient, whose age, gender, medical history and concomitant medications was not reported, had received a dose of FLUZONE QIV (Batch number, dose number UI205AC and expiry date, dose number, route and site of vaccination were not reported), on 09-OCT-2014. On 09-OCT-2014, the patient became very shaky after vaccination. Illness at the time of vaccination, Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Corrective treatment and Laboratory data were not reported. The patient required ER visit. At the time of this report the outcome was unknown. List of documents held by sender: none. Follow-up information received from a non-healthcare professional on 12 March 2015. It was stated that the event was not confirmed. List of documents held by sender: none.
Itching at the injection site; swelling of arm; Redness of injection site; swelling on the injection site; Itching and redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at the injection site), PERIPHERAL SWELLING (swelling of arm), INJECTION SITE PRURITUS (Itching and redness on injection site), INJECTION SITE ERYTHEMA (Redness of injection site) and INJECTION SITE SWELLING (swelling on the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching and redness on injection site) and INJECTION SITE SWELLING (swelling on the injection site). On 10-Mar-2021, the patient experienced PRURITUS (Itching at the injection site), PERIPHERAL SWELLING (swelling of arm) and INJECTION SITE ERYTHEMA (Redness of injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Manual therapy (cold ice) for Injection site swelling. At the time of the report, PRURITUS (Itching at the injection site), PERIPHERAL SWELLING (swelling of arm), INJECTION SITE PRURITUS (Itching and redness on injection site), INJECTION SITE ERYTHEMA (Redness of injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt reports "muscle jumped" during administration, arm is still sore a month after vaccine.  Referred to md for evaluation.
PHARMACIST GAVE BIVALENT VACCINE WHEN PATIENT HAD NOT YET RECEIVED ORIGINAL PRIMARY SERIES, (GAVE AS DOSE #1), NO ADVERSE REACTION REPORTED, PATIENT WILL RECEIVE SECOND DOSE OF PRIMARY SERIES IN 4 WEEKS
Does not monitor freezer temperatures/Possible freezer temperature excursion; Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patients vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/potential sub potent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion).    Concomitant medications details were not reported by the reporter. It was reported that vaccines were stored, there were no monitoring of  the freezer temperature and those vaccines were administered to patients. Vaccination site had a data logger, but it was not set up to record. The HCP stated that there were no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow up : Quality complaint no. added