chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis.  3 trips to Emergency Department. Difficulty Breathing and Swelling of face or throat:  Received her 3rd dose (booster) Moderna vaccine at approx 1540. After about 5 minutes she began to have chest tightness and throat closing. She was alert and oriented and didn't have any trouble talking. She was monitored for an additional 5 minutes and noted her tongue swelling. Her tongue was visibly swollen and her oropharynx was significantly smaller.  Patient was administered 0.3 mg epinephrine and 50 mg benadryl. She didn't have any audible wheezes, rales or ronchi. She had red small hives on her cheeks and neck. As soon as the EPI was administered, 911 was called and RN remained with patient until EMS arrived.   ED: MEDICAL DECISION MAKING:   Patient is a 30-year-old female without past medical history presents with acute onset chest tightness, shortness of breath, throat swelling following COVID booster administration at 3:30 p.m..  She was given epinephrine at the clinic without resolution of symptoms thus prompting EMS who gave her IV Solu-Medrol prior to arrival.  Upon initial evaluation here, patient states interval improvement of her symptoms, vitals are significant for tachycardia to 103 otherwise satting 100% on room air. Physical exam without tongue edema throat swelling, lung sounds without wheezing.  She was given additional 25 mg of IV Benadryl, however developed another episode of chest tightness in her tongue discomfort with tachycardia and elevated BP to 150/70s.  Re-examination also benign, patient had intermittent elevated blood pressure to 150/70 that spontaneously resolved. Patient remained asymptomatic for the remainder of her emergency department course.  She states understanding of likely similar reaction for future COVID vaccinations.  She states that she has Benadryl and EpiPen at home.  She was given the option for short 3day course of steroids for anaphylaxis however she declined.  She was given strict return precautions and discharged in stable condition.  3rd ED: MEDICAL DECISION MAKING:  30 year old female with no significant PMHx presenting with tachycardia. She was recently seen in the ED on 11/12 and 11/13 for anaphylactic reactions after the COVID booster on 11/12. She self-administered Epi on 11/12 and 11/13 and was started on Prednisone yesterday. Concern for delayed anaphylactic reaction, possible response to multiple Epi administrations with initiation of steroids, or underlying arrhythmia. Vital signs were stable upon arrival with her physical exam unremarkable. CBC and CMP were obtained and were unremarkable. Troponin was ordered per patient request with no reports of chest pain. TSH was normal. Zio patch was ordered upon discharge. Patient was then stable for discharge.  Patient to follow-up with Allergy immunology to assess for component of vaccine the patient is allergic to and how to approach future vaccinations.  At this time patient should avoid any further COVID immunization
Significant unexplained weight gain (over 15 lbs in 2-3 months) in extremely active individual (workout 5-6 days/week) with no change in prior habits. Removal of ovulation and alteration in menstrual cycle and unexplained sudden issue with low progesterone.  Vaccination series dates: 7/21/21, 8/11/21, 1/27/22
Product leaked out from his left arm at injection site; A spontaneous report  was received from a nurse concerning a 53-year-old, male patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced some of the product leaked out of his left arm at the injection site.   The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) on (date of vaccination not provided) in the left arm for prophylaxis of COVID-19 infection.   A nurse called to report that a patient who had received their first dose of the Moderna COVID-19 vaccine, experience some of the product leaking out of his left arm at the injection site. Nurse stated that the patient did not receive a full dose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The events, some of the product leaked out of his left arm at the injection site, was considered resolved.  The reporter did not provide an assessment of the events, some of the product leaked out of his left arm at the injection site.; Reporter's Comments: This case concerns a 53 year old male patient who experienced a non-serious unexpected event of Vaccination site discharge.
Information has been received from a registered nurse concerning her approximately 16 year old sister in law's daughter who on an unspecified date was vaccinated with a dose of GARDASIL (Lot number unspecified). The registered nurse reported that the patient was diagnosed with Non-Hodgkin's lymphoma after vaccination with GARDASIL. At the time of the report the status of the patient was unspecified. The patient sought medical attention. Upon internal review, Non'Hodgkin's lymphoma is considered to be an other important medical event. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Information has been received from a physician concerning an approximately 15 year old female patient who on unspecified dates was vaccinated with 0.5 ml 3 doses of GARDASIL (lot#'s not reported). It was reported the the patient had an abnormal PAP smear. The patient had the third injection in the series. At the time of the report, the patient had not recovered. It was unknown if the patient sought medical attention. Additional information has been requested.
Vaccine was administered on 05/17/2023, but had expired on 05/11/2023.  Nursing staff noticed after administration when entering vaccine information into the system.
pt recv vax 25AUG97 & 28AUG pt exp h/a, severe rt sided neck pain, & extreme dryness of eye, causing immed disposal of contact lens;29AUG PM taken to ER w/rt sided facial paralysis to r/o stroke;rt ear extremely sensitive to sound. It was reported that the patient recovered from this experience without any sequalae
Fever (103), nausea, tachycardia (130 resting HR), muscle aches, headache All resolved after 48 hours
Appearance of 4-5" diameter circular bright red rash on lower abdomen accompanied by an odor.  It did not itch or swell. There were no other symptoms.  I did not relate this rash to the shingles vaccine until I received the 2nd dose on 12/20/21 when the exact same circular bright red rash appeared at the same location.  The first dose rash disappeared in about 5-7 days. I washed it frequently, thinking it was caused by sweat and some type of bacteria.  The second dose rash is still present on this date, 12/23/21, and is starting to diminish. There are no other symptoms, again, no itching or swelling or other symptoms other than soreness at the injection sight which was not present with the first dose.
SIDE EFFECTS TURNED OFF SOME PEOPLE; This solicited report received from a pharmacist via an agency: COVID 19 Booster Exploration concerned multiple patients. No past medical histories or concurrent conditions were reported. The patients initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin Unknown, batch number: Unknown, expiry: Unknown) doses, start therapy dates were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. During qualitative research interview, on an unspecified date, multiple patient experienced side effects (unspecified) that turned off some people. The reporter described general perceptions of the JnJ COVID-19 vaccine and said that "side effects "turned off" some people and immunizers from JnJ COVID-19 vaccine. Also mentioned general perception that immunity does not last as long." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects turned off some people was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and side effects "turned off" some people and immunizers from j&j covid-19 vaccine as related. Company causality between covid-19 vaccine ad26.cov2.s, and side effects "turned off" some people and immunizers from J&J covid-19 vaccine was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220139723-COVID-19 VACCINE AD26.COV2.S- Side effects "turned off" some people and immunizers from J&J covid-19 vaccine. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Mom states that 3-4 hours post vax, the pt developed a fever of 105. Pt given Motrin and fever dropped to 102. Mom states pt did fine with Motrin. Pt had febrile seizure with temp. A seizure later was also related to fever.
pt rcvd 3rd dose of vax; pt exp eye watering, lip lesion, left sciatic nerve discomfort; continuing leg & foot pain;
Since I got the vaccine I'm allergic every day; I have hives all over my body, huge, red, itchy bruises; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Since I got the vaccine I'm allergic every day"; URTICARIA (non-serious), outcome "not recovered", described as "I have hives all over my body, huge, red, itchy bruises". Therapeutic measures were taken as a result of hypersensitivity, urticaria.  Additional Information: Everyday patient needed to take anti-allergic.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt c/o nausea & vomiting onset 4-11PM & cont on 12APR & also c/o temp 100, chills, diarrhea, joint pain;some discomfort @ inj site also on these days;pt is concerned about whether to recv hep B #3;
This spontaneous report was received from a pharmacist referring to a 70 year old female patient. The patient's historical drugs included PREVNAR at least 1 year ago. The patient's had no allergies. On 06-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, intramuscularly (also reported as subcutaneously), in the left deltoid, lot # N019348 with expiration date 08-Feb-2019, for vaccination (route of administration was not reported). Other suspect therapies included FLUAD, in the opposite arm. The patient's concomitant medications (reported as "a ton of medications) included budesonide, formoterol fumarate(SYMBICORT), unspecified blood pressure medication and unspecified eye drops for glaucoma. On 08-OCT-2017, the patient presented to the pharmacy with a cellulitis type reaction described as swelling and a wet, blistery, awful looking rash from the site of injection on the left deltoid down to or past her elbow (injection site cellulitis). It was stated that the patient was referred to her physician or hospital but the pharmacist was unsure if she went or not. It was reported as a "horrifying reaction" with "really bad symptoms". At the time of reporting, the outcome of the adverse event was reported as not recovered. The causality assessment between cellulitis type reaction and PNEUMOVAX 23 was not provided. The reporting pharmacist considered cellulitis type reaction as medically significant event. This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1710USA005880:
PATIENT WOKE IN THE MIDDLE OF THE NIGHT WITH A FEVER, CHILLS, NAUSEA, AND CONFUSION/DELIRIUM (GENERALLY NOT FEELING RIGHT). HER HUSBAND CALLED AN AMBULANCE FOR HER AT 4AM AND SHE WAS TAKEN TO THE ER WHERE THEY RAN TESTS THAT WERE INCONCLUSIVE. SHE RECEIVED A DOSE OF ZOFRAN FOR NAUSEA AND TYLENOL FOR FEVER. SHE REPORTS THAT SHE FEELS FINE TODAY AND THAT THE SIDE EFFECTS HAVE RESOLVED.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Selective IgA deficiency" (unspecified if ongoing), notes: Selective IgA deficiency; "Dairy and eggs allergy" (unspecified if ongoing), notes: Dairy and eggs allergy; "Dairy and eggs allergy" (unspecified if ongoing), notes: Dairy and eggs allergy. Concomitant medication(s) included: VALTREX; LEXAPRO; WELLBUTRIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient received Covid treatment. COVID 19 Treatment start date was 08Jun2022. The patient received other medication in 2 weeks. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & had local rxn; pain & swelling; redness; heat; pain from shoulder to elbow; also noticed small lumps; cysts still present;
PT REPORTS FLU-LIKE SYMPTOMS FOLLOWING THE VACCINE AND IN THE EVENING, STATES HE DEVELOPED A SEVERE HEADACHE. HIS ARM WHERE HE RECEIVED THE VACCINE HURT CONSIDERABLY, BUT HE ALSO DEVELOPED CHEST TIGHTNESS AND MUSCLE TIGHTNESS AROUND HIS NECK THAT HE SAYS MADE IT DIFFICULT TO BREATHE. BY THE MORNING SYMPTOMS HAD NOT IMPROVED SO HE WENT TO THE EMERGENCY ROOM WHERE HE WAS ADMITTED. PER PATIENT, CARDIAC TESTS INCLUDING AN ECHO WERE "FINE" AND THE PAIN RESOLVED AFTER SEVERAL DOSES OF TORADOL AND ANOTHER PAIN MEDICATION.
This spontaneous report was received from a female patient of unknown age referring to herself. On 12-NOV-2013, the patient was vaccinated with ZOSTAVAX vial, dose: standard/single dose, route: injection (lot number was not reported). No concomitant medications were reported. On 13-NOV-2013, one day after receiving ZOSTAVAX, the patient experienced injection-site redness, lump, soreness, swelling and warmth. The patient did not seek medical attention. The outcome of the events was reported as not recovered. Additional information is not expected.
Intense whole body aches, some chills, started at bedtime, lasted until next midmorning.  Self treated with OTC NSAID plus CBD.
Patient is  experiencing extreme arm pain down arm.   This has been occurring for over 3 weeks.  Have tried Tylenol, ice pack, lidocaine patch, still hurting
Red arm day after and swollen. Used ice pack and IBU. Swelling and redness went away. Where injected arm has a dull ache where injected and when you push on that area it feels like lump is there under the skin. Hurts when moving at the point of injection.
Arm pain starting on 12-11-20. Severe aches (headache, neck, arms, shoulders, legs, fingers) starting in the middle of the night on 12-12-20. Tiredness.
Pt recv vax in 4/98; in 9/98 pt exp right side weakness w/ inability to hop on one foot; dx=multifocal inflammatory myopathy
Patient complained of blistering reaction to face, arms, chest, and torso the day after the vaccine and continued for 2 weeks afterwards. Patient did not go to doctor/hospital. Patient made the determination on her own the rash was a result of the HD vaccine as it was the only change in patient history. Daughter also noted this is the first time patient had HD, she's received the standard vaccine in the past with no issues.
Right arm has began numb from her right elbow down since she left the Health unit last friday after her shot on 07/31/2003.  Actual date.  The girl gets on the phone when requested to talk to her.  States her right arm has been numb from her elbow down since her injection and her left hand was swollen Saturday for one and one half days.  I told them to see their PCP they have recently moved here.  I told them they need to go to hospital to have the arm evaluated.  Lady wanted to know if it was normal for the arm to be numb.  08/08/2003. Patients mom did not go to hospital with client due to lack of transportation.  She said she may take her to another clinic.  I gave her the phone # and asked if she would call me with the results. 08/14/2003: Spoke with patients mom-states she called the clinic.  Explained situation.  She was told to go to hospital.  She took her daughter to ER.  Was told her reaction was normal she was given an injection in her hip for pain and was told to take Aleve for pain and guaranteed mom that her daughter would be better.  Mom said daughter only slightly better.  She plans to call hospital for an appointment tomorrow.
2 minutes Post vaccination, client experienced a syncopal episode lasting approx. 5 sec. While walking to the observation area. No injury occurred on site.  Client was placed on the floor, legs elevated, vital signs initiated, cool packs provided. When in seating position water and lollipop was offered. Client stated to have an empty stomach.  Observation extended for an hour. Symptoms fully resolved when pt left the site. Oriented x4 and ambulatory.
2 days after being vaccinated the glands under my right arm was swollen. My obgyn sent me for an ultrasound 01/19/2022 and it was normal.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's weight was 188 pounds, and height was 65 inches. The patient's concurrent conditions included: penicillin allergy, alcohol user, and non smoker. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
fever of 101.0; Chills; Body aches; Extremely tired; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 36-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL 3247), via an unspecified route of administration, administered in arm left on 25Feb2021 at 13:00 (01:00 PM) (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient had no allergies to medications, food, or other products. The patient concomitant medication included rosuvastatin calcium (CRESTOR) at a dose of 20 mg daily taken for an unspecified indication, start and stop date were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 04Feb2021 at 01:00 PM as dose 1, single for COVID-19 immunization. On 26Feb2021 at 09:00 AM, the patient experienced fever of 101.0, chills, body aches, extremely tired. The patient underwent lab tests and procedures which included fever was 101.0 on 26Feb2021. AE: Body aches and run down <12 hours from injection. 18 hours after, fever of 101.0 and chills. Extremely tired and body aches also continuing. Query response received and confirmed (the patient) confirmed the adverse events on 26Feb2021 and submitted the report on the 27Feb2021. The patient did not receive treatment for the events. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
pt recv vax & became somewhat apneic approx 2-3hrs p/vax;adm to hosp,still in NICU;
4MAY92 recvd 1st dose of Engerix-B in the PM exp feeling as though could not breathe; pt recovered w/o tx; following 2nd dose of vax pt was grasping for breath, had cramps, 4JUN92 h/a, exhausted;
was hurting on every single part of her body; she threw up all night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (was hurting on every single part of her body) and VOMITING (she threw up all night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VOMITING (she threw up all night). On 10-Jan-2021, the patient experienced PAIN (was hurting on every single part of her body). At the time of the report, PAIN (was hurting on every single part of her body) and VOMITING (she threw up all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Intense itching and redness of the skin mostly on back, buttocks, upper legs, especially after exposure to hot water
She developed an allergic reaction with a rash; She developed an allergic reaction with a rash; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter called for information about if the treatment she was receiving for the management of an allergy could interact with the administration of the second dose of the Pfizer's COVID-19 vaccine on 03Mar2021. The consumer reports that she developed an allergic reaction with a rash on unknown date and she was received treatment for this condition. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.