chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm from where patient received his injection; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache) in a 42-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 15-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 microgram. On 16-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 16-Oct-2023, the patient experienced INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache). At the time of the report, INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter. treatment medication also not reported.  Patient woken up with a mild headache and a sore arm from where he received his injection The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge). At the time of the report, SWELLING (my son came to visit one day after he had received the vaccination, and the left side of his body was completely swollen and huge) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. The reporter stated that the patient came to visited one day after he had received the vaccination, and the left side of his body was completely swollen and huge. No treatment medication information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-727504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727504:Reporter's Case
WORSE HEART PALPITATIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. 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 JAN-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced worse heart palpitations. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of worse heart palpitations was not reported. This report was non-serious.
Itchiness, redness, swelling and warm to the touch. Redness was present in the shape of an oval. Patient applied rubbing alcohol to it; to cool injection site. No fever.
DOSE GIVEN POST EXPIRY TIME; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-JUL-2021, the subject experienced dose given post expiry time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given post expiry time was not reported. This report was non-serious.
Patient had reaction to pfizer dose 1 where they experienced a funny taste, prickly tongue. Her tongue felt like she had eaten a lot of spicy food. All of this occurred at 9:45am, 7 minutes into her 15 minute wait. Benadryl was given by a Nurse at 9:47am. Patient observed for 30 minutes after benadryl was administered. She was then picked up by her husband. Patient was instructed to go to the ED if she experienced further symptoms. Also instructed to consult her PCP before scheduling her second dose appointment. Blood pressure was 139/95 (9:55am), then 144/89 (10:10am)
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No treatment and concomitant medications were provided.  patient received second dose on 04Mar2021 and third dose on 06Nov2021.  The patient states she already reported her side effects to V-Safe in March after she had the second vaccine. The patient declined to provide further information. Consent declined for safety to contact the patient.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Significant Follow up received on 08112021 contains updated reporter information and patient demographics along with dose details.
Information has been received from a physician concerning a patient, with a seizure disorder, who was vaccinated once with a 0.5 ml subcutaneous dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  It was reported that the child had a seizure after getting vaccinated.  Subsequently, the patient  recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  no other information was provided.  upon internal  review, seizure was considered to be an other important medical event.  Additional information has been requested.
This spontaneous report as received from a nurse via company representative refers to a non-pregnant female patient of unknown age. The patient had no pertinent medical history. On 27-JUL-2016, the patient was vaccinated with a dose of GARDASIL (lot#, dose and route of vaccination were not reported) in the left arm. On the same day, the patient experienced dizziness, light headedness. The patient did not seek medical attention. No treatment was given for the adverse event. The outcome of dizziness was reported as recovering/resolving. The relatedness between dizziness and GARDASIL was not reported. Additional information has been requested.
I had a mild/moderate reaction to the vaccine with the first 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses). At the time of the report, VACCINATION COMPLICATION (I had a mild/moderate reaction to the vaccine with the first 2 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-294075 (Patient Link).
Itching; Rash, in the creases of the upper arm and in the inner thighs, after first vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other HCP reported that an 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not re-ported) via an unspecified route of administration on 10Jun2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 10Jun2021 the patient experienced rash after her first dose of the Pfizer Covid-19 vaccine. Per the patient's daughter, the rash occurred several hours after the first dose in her upper arms creases and inner thighs, and it lasted for 2 days. There was no itching or swelling associated with the rash. The patient was taking a medication at the same time that did cause itching. The reporter wanted to be sure it was alright to administer the second dose of the Pfizer Covid 19 vaccine, to the patient. Therapeutic measures were taken as a result of itching. The clinical outcome of the event rash was recovered in Jun2021. Outcome of the event itching was unknown.  Information on the lot/batch number has been requested.
Reddened warm knot area on arm where injection was done. Still there 2 weeks later improving
headache, fatigue, 02/16 thru 03/25/21 tongue thickening, 02/18 thru 02/25/2021 swollen face, throat, 02/22 thru 02/25/2021 Doctor prescribed PredniSONE 20 MG TAB CADI beginning 02/25/2021 for 5 days, on going, no outcome
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L033707, expiration date: 18-MAY-2017) (dose and route unspecified). These vaccines were exposed to 31.5 degree Fahrenheit for 208 Hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient presented to ER with generalized weakness and fatigue progressing over the last 2-3 days.  Could not eat all day long and had difficulty standing. He felt he could not speak as well due to the weakness.  He admitted to being exposed to COVID 3-4 days ago and took a home test that was positive. Upon arriving to ER he had a dusky appearance, 60% on pulse ox.  He had dusky upper and lower extremities.  He was placed on a non-rebreather.  Breathing treatments and steroids were started. He is currently on 60L High flow nasal cannula after 4 days.  Also diagnosed with Acute Kidney Injury, Hyperglycemia, Lactic Acidosis and elevated troponin.
Fever, HA, chills, fatigue, pain at site, rash, abd. pain, nausea. OTC pain meds, warm compress, rest x 4 days.
I had severe chills, felt as if I was in tube of ice water, I ached all over, mouth very dry, tightness in my throat. I had a horrible night.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. On 20-JUN-2016, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. On 29-JUN-2016, the patient was vaccinated inadvertently with GARDASIL dose 3, 0.5 ml, intramuscular. No adverse effects were reported. Additional information has been requested.
Patient had anaphylatic reaction consisting of tightness to throat, urticarial rash, SOB, cough
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 19-JAN-2016, the patient was vaccinated with improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had nine temperature excursion: 88 hours, 152 hours, 40 hours, 64 hours, 328 hours, 64 hours, 488 hours, 1016 hours and 72 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 48 F (8.888888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
pt states started itching 30JAN or 31JAN93; 1FEB rash appeared on arms, belt line & below waist; feet itched; four fingers on lt hand swollen, ring finger on rt hand swollen; hands feel funny & feels good to massage;
Bruising red hard inflammation at injection site.  Extremely sleepy within hour of injection lasted 3 days. Itching all over on day 2. Called online Dr for advice. Was told to take Benadryl and use hydrocortisone cream. Was also told it was normal reactions.  Missed day of work. Day 4 injection site not as inflamed and itching is gone.  Site is still sore and bruised looking with little redness left.
This is an initial spontaneous report from a contactable reporter. This is the second of the two reports by the same reporter. A consumer, the mother of a currently 8-year-old son (race unknown) received a dose of PREVNAR 7 on an unspecified date in Jan2005. The patient had previously received 3 doses PREVNAR on 30-Dec2003, Feb2004 and Jul2004. Concomitant vaccines administered on an unspecified date in 2007, included HIB vaccine, TETANUS and DTAP. Relevant medical history was unknown. On an unspecified date in Mar2006, the patient was diagnosed with a sinus infection. On an unspecified date in Aug2006, the patient experienced cellulitis on the left leg for which he was hospitalized for two days. On an unspecified date in 2006, the patient experienced asthma. On 26-Jan2007, the patient was (term reported as) re-vaccinated with a dose of PNEUMOCOCCAL POLYSACCHARIDE vaccine, reported as a suspect vaccine. On an unspecified date in 2007, the patient had pneumococcal blood work done that showed the level of pneumococcal types 15 and 37 were high after the revaccination, and later after four months (date not specified) the blood work showed that the level of pneumococcal types 3, 4, 8, 19, 26, 57 and 68 had dropped. The patient's B-lymphocyte antigen CD19 showed a high count on an unknown date while receiving PNEUMOCOCCAL-23 vaccine. On an unspecified date, the patient had his adenoids removed. Treatment included amoxicillin (unknown dose and frequency). Treatment was administered on unspecified dates when the patient's pneumococcal types 3, 4, 8, 9, 19, 26, 57, and 68 went down (2007) and additionally, the patient was treated (dates not specified) with an unspecified antibiotic for asthma. The clinical outcome of the reported events was unknown at the time of the report.
On 7/6/12 pt woke up with intense pain in (L) arm, tender to touch, noticed swelling and redness.
Injection Sunday @ 2:00pm.  +-8:00 pm Sunday upper arm was slightly swollen.  The area was slightly pink.  Monday the swelling increased, as did the pink.  Tuesday Increased swelling, increased redness.  Wednesday (today) less swelling, increased redness.  Arm continues to have the same "burning " sensation as the day of the injection.
After adminstaration of vaccine, patient has fainted after 5 minute after administration. Paramedic came and took vitals signs and ekg.  Patient symptoms subsided and she spoke to a behavioral health. As her smptoms dessipate she was release by the nurse.
Broke out in classic Varicella rash - presented 1 week later. Treated with Zyrtec and Omnicef for impetigo.
Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for, what they called "CHF flare-ups". Her last hospitalization began on January 30, 2021. Her social worker reported on t1/31/21 that "she would likely be returning in another day or two".
Pt recvd 3 doses of Hep B vax on 24APR91, 22MAY91, & 18OCT91; following 3rd dose pt exp diarrhea & sl h/a; pt later recovered;
I was having abdominal and back pain in May2021 and went to Urgent care in June 2021, small stone found in CT scan and no prescription. July and august 2021, I was in a meeting and the pain was painful and I couldn't even speak and ER and 2nd CT scan and found a larger stone. Got medication to dissolve the stone. referred to Urologist. Sept 2021 3rd CT scan, The pain moved to the lower part and groin. Concerned that the stone was in the kidney and the results were that the stone was gone. So there was at least 2 stone since Mar2021. Looking to change the migraine.  I still abdominal issues .
PARENTS NOTIFIED, PT RAN LOW GRADE FEVER. PT MOTHER CONFIRMED THAT THERE ARE NO OTHER REACTIONS AT THIS TIME. WILL CONTINUE TO MONITOR.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patients were inadvertently vaccinated with improperly stored doses of GARDASIL 9 (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additionl information has been requested.
Patient immediately developed red small bumps at injection site and by the evening area was sore and red.  Next day, the red rash started to go down arm towards elbow.  Patient called doctor a couple of days later. By the 3rd/4th day mobility issues started. Fingers on the left arm lost mobility; patient cannot open hand fully.  Patient had a doctor visit on 10/7 and given referrals.  On 10/10 started occupational therapy in Center.   On 10/11 went to neurologist, and got an EMG test.   Point of contact for care is her PCP.  Patient had telephone appointment on 10/15, and has another telephone appointment scheduled for 11/21.    There were no results from testing and no improvement so far since therapy started.  Rash resolved within 6 days. Patient has received the Flu vaccine prior with no problems.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right 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 had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: then test returned to being strongly Positive with nasal congestion for further Seven days; (Jul2022) Negative, notes: Rebound of COVID symptoms eight days After initial symptoms and two days after Final PAXLOVID dose tested negative; (Jul2022) Negative, notes: Rebound of COVID symptoms eight days After initial symptoms and two days after Final PAXLOVID dose tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: No. Known allergies: No. Other medical history: None  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Postmenopausal bleeding two years after stopping my period. It's a full period with bleeding and cramping. I have a doctor's appt on Friday, the 5th. No treatment yet. It's a full period and still going.
INCORRECT PRODUCT STORAGE; THE VACCINE WAS KEPT IN THE FREEZER WHEN RECEIVED (THE POSSIBILITY OF BEING FROZEN TWICE) AND LATER INJECTED; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194, expiry: 09-APR-2022) dose was not reported, administered on OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced the vaccine was kept in the freezer when received (the possibility of being frozen twice) and later injected. On 26-OCT-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the vaccine was kept in the freezer when received (the possibility of being frozen twice) and later injected and incorrect product storage was not reported. This report was non-serious.
Injected 0.5ml FLUVIRIN into pt left arm IM 8/12/11 4:35p. Pt became disoriented immediately and went limp. Her breathing was shallow. Injected 0.3 mg epi into left thigh. She became oriented again and vomited 3-4 times. Pt was clammy and cool to the touch.
Little itching when sleeping. Woke up to 9 cm round area of redness, warm to the touch, firm and swollen.  It lasted 2 1/2 days then she was fine.
redness, warmth, erythematous, sl tender 10x20cm area rt lateral arm; mostly distal to inj site
Noting large hives, quite reddened, and itchy. Beginning to fade and less itchy
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (route and lot # not reported) exposed to 8F for 15 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Skin: rash noted to torso- scattered papules  mom reports new lesions have appeared since this am.
Received vaccine on 12/31/12. Softball size area lump & center red & warm to touch.