chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1100, patient reported feeling shaky, dizzy, and faint to EMT. Patient had unlabored respirations, alert and oriented x4, and able to follow commands. Patient assisted to anti-gravity chair. EMT assessed patient vitals: blood pressure 98/58 mmHg, heart rate 42 beats/minute, and SpO2 96%. Patient reported not eating breakfast. Patient given water and crackers. Patient advised to wait for further observation. Patient reassessed at 1130. Patient vitals were blood pressure 122/72 mmHg, heart rate 70 beats/minute, and SpO2 97%. Patient stated he felt good and reported no earlier symptoms. Patient educated patient on eating before his second dose appointment. At 1134, patient left facility to self with unlabored respirations and steady gait.
Treatment of Covid-19; Treatment of Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Aug2023) negative; (09Aug2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Jul2023 to 05Aug2023.
Pt had localized reaction with mild redness at injection site, (L) anterior thigh. Mild fussiness for 24 hours. Low grade temp. KEFLEX susp. ordered TYLENOL.
Pt received her COVID booster in office last Wed. That Friday night she got her period and it was heavy which is not nml for her. Over the next couple days it became significantly worse. Was needing to change her super pad 6-7x/d, stayed like that until 2/8/22, on 2/8/22 went thru 3-4 pads/d, sat'd.   Having cramping over the weekend as well-using tylenol and advil-decreased in pain and now more manageable since yest. Typically doesn't have this much pain.  Also Sunday night, Mon night, and Tues night pt woke up in the middle of the night with a heavy nose bleed, had some similar ones when she was little. Would wake her up and was clotting, stopped easily. Has not had a nose bleed since age 4-5 yrs. Mom says that she went through 4 pillows and top layers of a comforter with blood.  Seems to be more tired than nml as well  Period flow has decreased and is at what is her nml amount is now.  No fainting, no CP, no SA/HA  PGF has hemophilia. Pt has had no prob with excessive bleeding until now, outside of nosebleeds as a child before the age of 4-5 yr. No excess bleeding with falls/trauma. No recent gum bleeding.
Decreased arm mobility; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMOVAX).   On 6th November 2019, the patient received Shingrix (intramuscular). On 6th November 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown.   It was unknown if the reporter considered the injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient was vaccinated with both Shingrix and Pneumovax. In the arm that had the Shingrix administered, within hours the patient was unable to move his arm from the shoulder down. Within a few more hours, it was only decreased mobility from shoulder to elbow. The reporter consented to follow up.
Patient's states that she woke up at 3 am on 1/7/2021 with left sided facial swelling and lip swelling and she went back to sleep and woke up again around 5:30 am and swelling had gone down, and then at 10:30 am patient reports that left facial swelling and left lip swelling completely resolved. Pt. denies taking anything to resolve swelling of left face and lip.
Mother of client called health department and reported history on 8/25/2008. The patient attended an outdoor wedding previous weekend before getting the shot. She contracted a rash, poison Ivy type rash.  Recalls possible tingling in her legs on 8/10/08. She has a previous hx of asthma.  Immunizations, Menactra and Tdap were received on 8/12.  She reported tightness in chest and slight fever with a head ache on 8/13/2008.
mom reported pt started crying soon p/vax were given & cried for over 3hr nonstop;4hr p/shot pt became extremely pale & lifeless-would not respond for 20mins was taken to MD;pt cranky
Case number PHEH2014US025144, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 19 year old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2015. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
FEVER AND RASH, BUT ALSO HAD AN EAR INFECTION DIAGNOSED WITH THE RASH.
2 hr following vax, pt exp "chills & shakes" for 20 min. He also exp "flu-like symptoms". See comments.
Redness and swelling that extended 10" long and 5" wide with tenderness to preparation in left thigh near vaccination site. Patient was given Zithromax 200mg/5ml for 5 days.
The day after the vaccine, patient's leg swelled significantly and the injection site was extremely swollen, red, and hot to the touch.  She complained that her leg hurt to walk on.  Later in the evening she complained of a headache and no appetite.  After getting her to eat a small bit, she continued to complain of stomach ache.  Her headache turned severe and she went to bed.  Upon climbing into bed she started vomiting and she vomited on two different occasions.    She continued to complain/cry about a severe headache, along with intense leg pain, and stomach pain upon which, I (her mother) called the doctors office about the reaction.  We were told to try to keep fluids in her and wake her every 2 hours at night to check her for neurological deficits and if any were present to immediately take her to the ER.  She did not want to get up out of bed the rest of the evening due to the significant amount of discomfort she was in.
BLOOD CLOT; This spontaneous report received from a pharmacist concerned a 26 year old female of unknown ethnicity. The patient's height, and weight were not reported. The patient had no known drug allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: unknown) dose was not reported, 1 total dose, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date (after vaccination), the patient experienced blood clot. The pharmacist thought, that she has been treated, and at the time of this report she was at home, but he was not 100% sure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522731-Covid-19 vaccine ad26.cov2.s-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm pain). On 03-Feb-2021, VACCINATION SITE PAIN (arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication was reported.  Patient gave consent to safety for Follow-up.   This case was linked to MOD-2021-035340 (Patient Link).
Pt exp a large area of erythema & warmth (approx 5" x 3") @ inject site p/receiving Influenza vax; Pt recovered in five to six days;
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient's mother reports that the day following injection she started with normal immunization reaction (low grade fever, lack of energy).  By second day post injection she developed a rash on legs, and the 3rd day she developed throat tightness and trouble breathing.  She was seen in emergency room and given injected steroids to treat reaction.
abnormal pain in the neck; abnormal pain in the joint and shoulder; Initial information received on 19-Oct-2021 regarding an unsolicited valid  non-serious case from a consumer/non-health care professionals via Media Information (under reference number 00819410).  This case involves a 70 year old female patient who experienced abnormal pain in the joint, shoulder and neck (arthralgia) (neck pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 19-Oct-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once in total, immunization, lot number VJ690AA and expiry date not reported) via unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious abnormal pain in the joint, shoulder and neck (arthralgia) (neck pain), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  No laboratory data were provided.  It was reported "Caller received FLUZONE HD at a pharmacy. Caller states that she is in a lot of pain, and the pain is located in the joint, shoulder, and neck. Caller states that she believes she received the shot up too high by the shoulder. Patient is not sure if the pain is due to the vaccine itself or the shot technique. Patient did ask agent on how to handle the pain, agent directed caller to their primary care physician (PCP), and if the pain is to severe to there local urgent care or emergency room.Patient calling to report abnormal pain in the shoulder, joint, and neck surrounding a recent FLUZONE HD immunization. Caller states that she believes the pharmacist injected the vaccine too far up her arm which is causing her pain."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for both the reported events.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 62 year old female pt who experienced sneezing, runny nose, aching teeth, swollen left eye and watery left eye.  At 62 years of age, the pt received a dose on 12/12/03.  The pt has a past history of migraine headaches.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/12/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced sneezing on 12/12/03, and runny nose on 12/13/03.  On 12/16/03, her nose was extremely runny, her left eye was swollen and watery and her teeth on the left side ached.  No additional information was available at the time of this report.
About 2 days after injection, a rash has appeared and the arm is itchy in that area. These conditions have persisted... it's now 4 days after.
Patient came to the pharmacy on 6/1/2021 and stated that she had been lethargic and had a red swollen arm and swollen lymph nodes in the days following her second dose of Shingrix. She said that her symptoms had began to resolve and become better but she just wanted to let us know so we could document it.
Several large welts/hives appeared on arms, shoulders, and back. They resembled insect bites. They were very itchy. Took oral and topical antihistimine (Benadryl) about 10:00 PM same evening. Itching and welts were gone by morning.
Patient had immunizations Wed 1/3/07, by Friday after school mom noticed band aid, itching on left deltoid. Got ecchymosis below the puncture site. Bright red and swollen. Mother gave child Benadryl Saturday and Sunday. Itching a lot at left forearm. Today slight redness and warmth below puncture site.
More headaches, they say it's normal to get more after COVID shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right (Lot number: EN6198, Expiration Date: 30Jun2021) at the age of 63 years as dose number unknown , 0.3 ml single. The patient's relevant medical history was not reported. Concomitant medication(s) included: XGEVA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "More headaches, they say it's normal to get more after COVID shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: Time of vaccination was 10:30 am .  No follow-up attempts are possible. No further information is expected.
injection site irritation; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249 and Expiration date: unknown), via an unknown route of administration, in left arm on 17Jan2021 at 09:30 (at the age of 40-years-old) as dose 1, single for covid-19 immunisation. Patient has none medical history. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. Patient has no allergies to medications, food or other products. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On an unknown date in 2021, the patient experienced injection site irritation. It was unknown, if patient has received treatment for event. Outcome of event was recovered on an unknown date in 2021.   Follow-up attempts are completed. No further information is expected.
Patient recieved dose #3 (1st booster) of Pfizer on 8/19/2022. Primary dose series was given on 3/23/2022 and 4/13/2022. There were only 4 months between completion of primary series and the booster shot which is sooner than the guidelines of 5 months. Patient reported no adverse events to receiving this vaccine earlier than the recommended 5 month interval.
Information has been received from a health professional concerning a 7 year old female, with no medical history and no allergies, who was vaccinated with 0.5 mL doses of varicella virus vaccine live (Oka/Merck) on 11-OCT-2007 and 09-OCT-2007 (Lot# 658423/1180U). There was not concomitant medication. "About six days ago", on approximately 28-FEB-2008, symptoms began. Symptoms were described as bumps on the body itching, less than 50 pocks areas and no vesicles. It was reported that it appeared that the patient was no longer contagious. Subsequently the patient recovered. The patient was seen in the office on 05-MAR-2008. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 5-16-2008. Additional information is not expected.
High fever, Severe head ache that lasted for 1 1/2 days. Body aches.
Hives on back, hands, elbow - night after vaccine and up to 4 days after  Lots of itchiness all over body a few hours after vaccine  Intense joint pain and swelling keeps progressing - especially in wrists, fingers, and knees
broke out into generalized hives covering my whole body; lips were swollen and tingly; lips were swollen and tingly; throat felt itchy; small welts; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: fj8762) at the age of 28 years as dose 2, single and administration date 16Nov2021 02:30 (Lot number: fg3527) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XULANE. Vaccination history included: Flu vaccine, administration date: 02Nov2021, when the patient was 28 years old, for Flu vaccination.  The following information was reported: URTICARIA (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "broke out into generalized hives covering my whole body"; LIP SWELLING (non-serious), PARAESTHESIA ORAL (non-serious) all with onset 16Nov2021 04:30, outcome "not recovered" and all described as "lips were swollen and tingly"; THROAT IRRITATION (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "throat felt itchy"; URTICARIA (non-serious) with onset 16Nov2021 04:30, outcome "not recovered", described as "small welts". The events "broke out into generalized hives covering my whole body", "lips were swollen and tingly", "lips were swollen and tingly", "throat felt itchy" and "small welts" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of urticaria, lip swelling, paraesthesia oral, throat irritation, urticaria.  Additional information: After 1st vaccine, two hours later broke out into generalized hives covering my whole body and my lips were swollen and tingly, and throat felt itchy. went to urgent care and got treated there. improved with small welts coming up every couple days, then ten days after second vaccine had same reaction happen and not itchiness and welts have not completely gone away with treatment and I am almost a month out from second vaccine. Patient has received other vaccine within 4 weeks of receiving COVID-19 vaccine. Its unknown if patient had COVID-19 prior to vaccination. Patient had not been tested for COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
About 5-6 days after the vaccine, I experienced COVID arm. My right arm swelled up and my lymph nodes were enlarged. Right under my right jaw, there was significant pain. The swelling went away in a reasonable time. I forgot that I had the teeth pain, but the pain kept coming back. The pain continued to come and go. I went to a dental work up where my teeth were fine. By the weekend, I was having significant pain in my shoulder as well as my jaw. My doctor suggested physical therapy because it might be a impinged rotator cuff. The PT determined I did have an impingement. The pain in my jaw got worse. I was given anti-inflammatory. This clamped down the pain for a while and stopped working. I went back to my Dr. who determined the pain could not be a rotator cuff impingement. She eventually determined that I have nerve damage from the first Moderna dose. I was put on a stronger anti inflammatory which has taken care of the pain. My doctor also suggested cryotherapy which did help a lot. I do not have any pain now. I am still cautious with how I use my right arm because any movements can interfere with the nerve trying to heal.
A 39 year old female patient (LM) experienced headache, muscle ache and injection site tenderness after post exposure vaccination with RabAvert. The patient received a total of three doses of RabAvert 1 ml intramusclarly on 06/28/2004, 07/01/2004 and 07/06/2004. The first dose was given in her deltoid and the third dose was given on her left arm. Her past medical history was unspecified. She was significant for an emergency room visit on 06/28/2004 due to a feral cat bite and received treatment with Augmentin, human rabies immunoglobulin and tetanus booster along with RabAvert. She had no known drug allergies and was not on any concomitant medications prior to the events. On 07/06/2004, within two hours after the third immunization with RabAvert, the patient complained of a "horrendous" headach which she intervened by going to bed. The headache persisted throughout the night and to the next morning, 07/07/2004. At the time, she also noted "achy muscle" and tenderness at injection site. She self treated with Motrin 800 mg with improvement of symptoms. The patient planned to continue with RabAvert as post exposure treatment.