chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had sore arm; Started receiving this allergic reaction on her face and eyelids; Her eyes are swollen up 33 hours after; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had sore arm), EYE SWELLING (Her eyes are swollen up 33 hours after) and HYPERSENSITIVITY (Started receiving this allergic reaction on her face and eyelids) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 019B21A and 026A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Shingle shot. Past adverse reactions to the above products included Allergic reaction with Shingle shot.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (Her eyes are swollen up 33 hours after). On 04-Dec-2021 at 7:00 PM, the patient experienced HYPERSENSITIVITY (Started receiving this allergic reaction on her face and eyelids). On an unknown date, the patient experienced PAIN IN EXTREMITY (Had sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of Took maximum dose between 4 and 6 hours. At the time of the report, PAIN IN EXTREMITY (Had sore arm) outcome was unknown and EYE SWELLING (Her eyes are swollen up 33 hours after) and HYPERSENSITIVITY (Started receiving this allergic reaction on her face and eyelids) was resolving.            Concomitant medications information was not provided.  Reporter stated that patient had no side effects with her first and second shots.
Rheumatoid arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving.        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.   No concomitant and treatment information was provided.  Company Comment  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.; Sender'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.
Fever; Left arm hurts; Large red itchy bump; Swollen lymph nodes hurt under left arm; Very tired; Flu-like symptoms; Chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. The patient previously took cefprozil (CEFZIL) and azithromycin (Z-Pack) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation.  On 10Apr2021 at 22:00, the patient experienced chills, left arm hurts, large red itchy bump, swollen lymph nodes hurt under left arm, very tired and flu-like symptoms. On 11Apr2021, the patient experienced fever. The patient reported that, the chills started 13 hours after the injections and did not sleep during the night. She had fever of 39.7C, started after 26 hours of injection and took paracetamol after 26 hours of injection. She stated it took 2 days to go back to 37C. She also experienced left arm hurts, large red itchy bump, swollen lymph nodes hurt under left arm for 5 days, very tired and flu-like symptoms for 3 days. Therapeutic measures were taken as a result of fever and included treatment with paracetamol (MANUFACTURER UNKNOWN) from 11Apr2021 and unknown if ongoing. On 11Apr2021, the patient underwent body temperature test and the result was 39.7centigrade. On 13Apr2021, the patient underwent body temperature test and the result was 37 centigrade. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever was resolved on 13Apr2021, after a duration of 2 days; while that of the events very tired and flu-like symptoms were resolved on 13Apr2021, after a duration of 3 days. The clinical outcome of the event swollen lymph nodes hurt under left arm was resolved 15Apr2021, after a duration of 5 days; while that of the events chills left arm hurts and large red itchy bump were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
improperly stored dose of M-M-R II / VAQTA administered; no adverse effect reported; This spontaneous report was received from a registered nurse referred to a patient of unknown age and gender. Information regarding medical history, drug allergies or reactions and concomitant medications were not reported. On 24-JUN-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) with lot # R028381 and expiry date 03-OCT-2020 via subcutaneous route for prophylaxis (dose details unknown). On 24-JUN-2019, the patient was also vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) with lot # S002460 and expiry date 15-MAY-2020 via intramuscular route for prophylaxis (dose details unknown). Both the vaccines were stored at a temperature of above 47degree Fahrenheit within time frame of 2 hours. The digital data logger was involved. No adverse effects reported. Product quality complaint was not involved.  This is one of the several reports received from the same reporter (link case # 1906USA009882, 1906USA009902, 1906USA009914, 1906USA010076).; Sender's Comments:  US-009507513-1906USA009882: US-009507513-1906USA009902: US-009507513-1906USA010076: US-009507513-1906USA009914:01251178
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. The patient vaccinated on left arm. No concomitant medications were reported. On 22-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 22-MAR-2021. This report was non-serious.
experience numbness around the right ankle/It feels numb; tingling around the right ankle/feels like needles and pins; feels like sometimes something moving in there/feeling is not constant; feel it when they stand up; pain/hurts a little around the ankle; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (experience numbness around the right ankle/It feels numb), PARAESTHESIA (tingling around the right ankle/feels like needles and pins), FEELING ABNORMAL (feels like sometimes something moving in there/feeling is not constant), DYSSTASIA (feel it when they stand up) and ARTHRALGIA (pain/hurts a little around the ankle) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A21A) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), TEMAZEPAM and SUMATRIPTAN for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (experience numbness around the right ankle/It feels numb), PARAESTHESIA (tingling around the right ankle/feels like needles and pins), FEELING ABNORMAL (feels like sometimes something moving in there/feeling is not constant), DYSSTASIA (feel it when they stand up) and ARTHRALGIA (pain/hurts a little around the ankle). At the time of the report, HYPOAESTHESIA (experience numbness around the right ankle/It feels numb), PARAESTHESIA (tingling around the right ankle/feels like needles and pins), FEELING ABNORMAL (feels like sometimes something moving in there/feeling is not constant), DYSSTASIA (feel it when they stand up) and ARTHRALGIA (pain/hurts a little around the ankle) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-269806 (Patient Link).
Episode of hesitating breathing admited to hosp for 24 hrs; consultation w/MD recommended DT only in future;
Initial dose placed 12/23/20. On 12/31 (one day after placing Emgality shot for migraines) red circle on vaccine site injection and rash (inflamed mosquito-like bites) on left leg and right butt cheek. Took Benadryl. Rash on leg and butt cheek disappeared after a few hours. Reddish ring around injection site.
Received first dose of Shingrix on 9/17/2020.  No side effects of injection were noted at all from first injection. Second dose received on 10/28/2020 along with a flu shot.  Both injections given in left arm on same doctor's visit.  Soreness/pain at injection site on left arm was noted the day after the injection.  This was expected to last for up to several days based on manufacturer information.  Weakness and pain at the injection site have not gone away and continue 8 weeks after the injection.  Symptoms are not really present when working at computer, reading, cooking, or going about normal activities.  Weakness and pain are noted when exercising (especially with push ups) and also when arm is raised above head and elbow is bent.  Weakness and pain do not prevent me from completing my exercise, but it does hurt.
PATIENT COMPLAINING OF PAIN ONLEFT ARM. NO SWELLING AT INJECTION SITE. ONLY COMPLAINING OF MUSCLE PAIN.
rash as local to injection site; red rash; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site rash, red rash and itchy rash. On an unknown date, the outcome of the injection site rash, red rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced rash which was reported by the patient on 22nd september 2021 and was still present. The rash was local to injection site on left deltoid, at least six inches in length, red, and itchy. The reporter consented to follow up. This case has been linked with case US2021201404, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201404:same reporter
Had negative pregnancy test prior to vaccination with smallpox, found to pregnant via home pregnancy test later same day.
Mild Sore throat; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 31Mar2021 10:30 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation.  The patient medical history was not reported. No pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 or been tested for COVID-19. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC ALLERGY); paracetamol (TYLENOL); ibuprofen. The patient previously took amoxicillin and experienced hypersensitivity, septra and experienced hypersensitivity.  The patient experienced mild sore throat on 01Apr2021 04:00 with outcome of unknown. No treatment.   No follow-up attempts are needed. No further information is expected.
Narrative: COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 08/23 pt cc: No symptoms exposure: unknown 08/23 SARS-COV-2 Variant Sequencing result; pending 08/23 COVID swab, result: detected
Headache began first.  Then started to feel warm and nauseous around 8:45am.  Came to clinic at 9am (nearly 2.5 hours after vaccination).  Given gingerale and laid down.  Began to feel better.  Following walk trial, returned to work.
This report describes the occurrence of an injection site reaction in a 7 month old female patient who received DTaP, Heb B recombinant and IPV combined Pediarix for prophylaxis.  This report was received from the patient's mother and has not been verified by a physician or other healthcare professional.  On May 2003 the patient received the 1st dose of Pediarix.  At an unknown time post-immunization, in May 2003, the patient experienced an injection site reaction characterized by a bruise and a "knot".  The events were unresolved as of 06/16/2003.
Redness in the area distal to injection where it looks like a cellulitis like rash; Reaction at the vaccination site, red; reaction at the vaccination site, red, sore; reaction at the vaccination site, red, sore, hard; lethargy; loss of appetite / appetite loss; Loose bowel movements; redness in the area distal to injection; fatigue; This case was reported by a physician via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than 2 weeks after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue. On an unknown date, the outcome of the cellulitis, erythema and fatigue were unknown and the outcome of the injection site erythema and loose bowel were recovering/resolving and the outcome of the injection site pain, injection site induration, lethargy and appetite lost were recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Bexsero, the patient had a reaction at the vaccination site, red, sore, hard. Then developed lethargy, loss of appetite, loose bowel movement. After 3 days, the symptoms started to improve.   But at the time of reporting, there was redness in the area distal to injection where it looked like a cellulitis like rash. Upon follow up with Medical Information, it was reported that, at the time of reporting, the patient had what looked like cellulitis around the vaccination site, although not on it directly.  The patient's pediatrician did not know what it was but did not think it was cellulitis.  The patient's parent was a retired doctor and according to them, it did look like cellulitis. It was one week later.  The patient had initial reactions of pain, induration, lethargy, and appetite loss for several days. That disappeared at the time of reporting. The patient did not experienced pain. No further details were provided. The reporter did not consent to follow up.
Flu; Initial information received on 10-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  It was reported that every time the patient had the flu vaccine in the past the patient got bad case of the flu. No more. Stopped getting the flu shot and now the patient did not even get colds.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.
CHILLS, FEVER 101.8, HEADACHE, SORENESS AT INJECTION SIGHT, NAUSEA, FATIGUE TOOK TYLENOL FOR FEVER AND PAIN
Myalgia, Diarrhea, LBP, Chills, fatigue Narrative:  Other Relevant History:
Patient left with no s/sx after receiving Pneumovax at 5:30pm and called pharmacy the next morning at 8:30am with injection site redness/swelling.  This is a known side effect but patient was advised to take Benadryl and we would let his physician know about the reaction.  Otherwise patient said he is fine and wanted to let us know about the reaction he had.
Due to improper documentation of shots, extra dose was given . Pt had no adverse reaction because of this.
Pt recv vax on 9/28/98; on 10/1/98 pt exp puffy eyes & labia, 2 hives on back, edema, pruritus; tx=Benadryl
Minor brain attack; Partial loss of speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor brain attack) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Minor brain attack) (seriousness criterion hospitalization) and APHASIA (Partial loss of speech). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Minor brain attack) and APHASIA (Partial loss of speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included unspecified diabetes and blood pressure medications. Treatment medications included unspecified blood pressure and blood thinner medications.  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. However, the patient's age and comorbidities may be confounding factors for causality assessment.; 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. However, the patient's age and comorbidities may be confounding factors for causality assessment.
Acute Pain, swelling and redness/rash  at injection site. Acute pain lasted 48 hrs, rash and redness with itching are ongoing; moderate body aches, tingling in arms and legs; headache  lasting  48 hrs, chest pains, cough, shortness of breath, sore throat, runny nose. Body ache, cough and sore throat are ongoing as of today. No treatment yet. I am considering seeing my doctor if the rash does not resolve.  I am not planning to have the second shot/booster.
Severe pain from shoulder to fingers. Body tremors, fatigue, headaches, back pain, dizziness, low BP 81/53. 3 ER visits and 2 doctor office no one can diagnose.
The actual poke didn't hurt, but the actual vaccine entering my arm was uncomfortable, it felt like it was expanding, w/in a few minutes my arm felt like I had "dead arm". I have had vaccines before & never had that strong of a reaction, the discomfort lasted all day, tapered off quickly over the weekend & is much better today.
pt recv vax 28OCT96 & 4NOV96 pt devel a cough & congestion & was treated w/med;pt devel t99.0, anorexia & malaise;5 days later 23DEC96 pt expired-cause unk;
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 12 months old. The patient demographics were updated. On 05-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
I received my 1st COVID vaccine on 1/9/2021. On 1/17/2021 I woke with the injection site swollen and red and hard to the touch. Throughout the day, the swelling and redness reduced somewhat, but the area spread. The site was hot (99 degrees) compared to the surrounding area (96.5 degrees). The red area is now on much of my tricep.  It is not painful. If anything it is somewhat numb.