chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has been passing out after she received the the third dose; has a brain bleed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 85 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), notes: Verbatim: Autoimmune disorder. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 immunization; Bnt162b2 (Dose 2, single), for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "has been passing out after she received the the third dose"; CEREBRAL HAEMORRHAGE (medically significant), outcome "unknown", described as "has a brain bleed". Clinical course: The patient has an autoimmune disorder and has been passing out after receiving the third dose. The patient found out that has a brain bleed and needs more testing but never has had anything like this before. The patient stays at home and passes out a lot. The patient has been at home and will not leave her house now because she has passed out in a parking lot. The patient needs to report this since it hasn't happened before she got the vaccine. The investigation assessment was not provided. The patient taken all the three doses and information about dose was not provided. The reporter declined phone number, address, and email.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Noticed two days post vaccine - C/O sore throat and no other symptoms - symptoms about two days and then improved - OK now.
This is a spontaneous report from a noncontactable consumer (patient). A 39-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 39, via an unspecified route of administration, left arm, on Apr 8, 2021, at 15:00, single dose, for COVID-19 immunisation. Medical history included latex allergy. The patient previously received Celexa (citalopram hydrobromide), for an unknown indication from an unspecified date; and experienced drug allergy. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EP7534) via an unspecified route of administration, left arm, on Mar 17, 2021, at 11:30, single dose, for COVID-19 immunisation. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 9, 2021, at 04:00, patient experienced flu-like symptoms (nausea; headaches; fatigue) 12 hours after the shot, which lasted 4 days. The fatigue lasted 7 days after shot. No therapeutic measures taken as a result of reported events. The outcome of flu-like symptoms 12 hours after shot (nausea and headaches) recovered on Apr 12, 2021; while fatigue: recovering (at the time of this report). No follow-up attempts possible. No further information expected.
Tested positive for COVID after the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID after the first dose of the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (Tested positive for COVID after the first dose of the vaccine). At the time of the report, COVID-19 (Tested positive for COVID after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) positive.     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.   Treatment information were not provided.  Concomitant medications were not provided. This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.
Patient stated that throat sore initially and 25 mg of Benadryl was administered; checked on patient a few minutes later and stated her throat was tightening and 25 mg Benadryl was given again; 911 was called and patient was taken by EMS
pt recv vax AUG95 & on approx 15MAR96 pt devel a full body rash;sx were exacerbated by cold, heat, pressure & exercise;which resulted in hives;
Approximately 9 hours after receiving vaccine, patient complained of pain in left shoulder.  A large, red, hard raised bump was noted.
Swelling of lower left leg; hard and painful occurred within 7 days of initial injection unprovoked
Hives, hoarseness, shortness of breath, hives under arms, below eyebrows, at catheter sites for insulin pump around waist. Diagnose by nurse prac w/poison ivy!
Received vaccine at 1:30, then ate at 2:30. Went home by 4:00 and had a stroke at 4:30 while on the toilet. Was weak going into home and up stairs at 4:00.
Pt has swelling at injection site, it is warm to touch, and is about the size of golf ball and kind of painful, patient is also experiencing fatigue and has cited sleeping almost the entire past 2 days.
Started with chills right before bed, developed a fever overnight, woke up with headache, dizziness, nausea and fever. All symptoms continued through the day. Fever got up to 102.2. Woke up today (12/3/2020) with most symptoms gone except the dizziness
This spontaneous report as received from a physician assistant refers to a 23 months old female patient. The patient's medical history included contact dermatitis. Patient had no drug reactions/allergies. On 14-JAN-2014 the patient was vaccinated with VARIVAX (Merck) dose 1, subcutaneous injection for routine immunization. Dosing information and lot number were not provided. No concomitant medication was used. On 22-JAN-2014, the patient experienced vesicular rash. Patient visited the office for medical attention. The event was treated with nystatin cream for diaper area. No lab diagnostics studies were performed. The outcome of vesicular rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Received a 3rd full dose of Moderna after getting Sputnik V primary series; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Previously administered products included for Product used for unknown indication: Sputnik V (Dose 1, Batch number-1012977) on 27-May-2021, Sputnik V (Dose 2 and Batch number-006H21A) on 15-Oct-2021. Past adverse reactions to the above products included No adverse event with Sputnik V and Sputnik V.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series). At the time of the report, ACCIDENTAL OVERDOSE (Received a 3rd full dose of Moderna after getting Sputnik V primary series) outcome was unknown.            No concomitant medication information was provided.  It was reported that patient was not immunocompromised.  No treatment medication were provided.   This case was linked to MOD-2022-525755, MOD-2022-525740 (Patient Link).
History 39-year-old male patient with a past medical history significant for obstructive sleep apnea and anxiety presents with chief complaint of feeling dizzy, chest burning, and lightheaded shortly after receiving his first Covid vaccine here in the hospital.  He states he waited for the designated amount of time to be observed and then walked out of the hospital and got into his vehicle.  As he was leaving the parking lot he felt like he was going to pass out.  He states things were spinning and he felt lightheaded.  He developed a warm feeling from the lower abdomen up into his chest.  He states he felt like he had some chest pressure.  States he continues to feel lightheaded and has burning in his chest. Pati
About an hour after vaccination, Mother contacted the clinic and sent a photo of a rash on the BACK of leg - not at the injection site.  She was examined by Drs.   Accurate injection site (left vastus lateralis) confirmed .  A couple of hours later the rash resembled a tree, as though it were along a nerve patch, again, on the back of her left upper thigh.   Received oral benadryl administered by the doctors.
Great than 12 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Great than 12 hours at room temperature) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Great than 12 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Great than 12 hours at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. Pharmacist states that they administered Moderna COVID-19 vaccine that has undergone a temperature excursion to 3 patients. The punctured vial was placed at room temperature yesterday at 3:58 pm and was administered this morning at 10:09am 11:17am, and 11:22am. Administered this morning 11:17am, 11:22am, 10:09am. Treatment information was not provided.
Instant dizziness, lasting one day.  Site injection arm pain persistent to present day. Shortness of breath periodically.  Radiating pain to rest of arm.
Mass; Bone Pain, headache, pruritus, rash, musculoskeletal pain, warm sensation - Information has been received from female consumer who is a registered nurse who on 31 May 2000 reports recent exposure to several adults with shingles and several children with chicken pox. On 09 Jun 1999 the patient was vaccianted with one dose of varicella virus vaccine live (site unknown).  On 30 May 2000, the patient experienced a terrible headache and bone/spine pain.  On 31 May 2000 the patient reported that she developed 3-6 lesions on her back and she stated that it feels like her back is on fire and is very itchy.  She reported that she also has a rash on her upper truck under her breast which is new.  She stated that this was very unsual for her and she is going to call a pysician to schedule an appointment.  The patient sought unspecified medical attention.   Additional information has been requested.
Left Shoulder pain, upper arm swelling, and decreased range of motion. October 2018 went to Center and received steroid injection. 6-17-19 Continues to left shoulder pain, left upper arm swelling and decreased range of motion.
Feeling weakness on legs; Nervous feeling; Both legs and arms started shaking and twitching; Both legs and arms started twitching.; Pins and needle sensation in body and face.; Feeling of shakiness; Feeling of shakiness and rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 09:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to almonds, soybeans and hazelnut. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included rhamnus purshiana (CASCARA SAGRADA) from 28Apr2021 for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat. On 29Apr2021 at 23:45, 3 days after vaccination, the patient experienced both legs and arms started shaking and twitching which subsided about 20 minutes later. On 30Apr2021, in the morning the patient experienced no muscle twitching but felt weakness on legs and nervous feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both legs and arms started shaking and twitching was recovered on 30Apr2021, after the duration of about 20 minutes. The clinical outcome of the events pins and needle sensation in body and face, feeling of shakiness and rapid heartbeat, weakness on legs and nervous feeling was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recv vax; 22jan96 pt exp a low grade fever. 24jan96 spots that were mostly raised were noted on the abd.  25jan96 the rash was found on entire body; the child was fussy, but taking fluids and eating well; MD stated sx were rxn to M
presented to ED with c/o increasing SOB, confusion, cough, orthopnea, DOE and fatigue; on NRb 15 L/M; found to be hypoxic, A Fib with RVR; pt's condition worsened and he required intubation with ventilator; treated with dexamethasone and bronchodilators; living will of do not ventilate, family made pt comfort care and he died in the hospital
got the influenza A; Initial information received on 23-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an adult male patient who experienced got the influenza a after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant disease or risk factor and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient got the influenza a (influenza) (unknown latency).  It is unknown if there were lab data/results available.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the influenza A).  At time of reporting, the outcome was Unknown for the event got the influenza a.
2 hrs after the shot: fever, chills 3 hrs after the shot: allergic reactions, hives
Severe dizziness within 5 minutes of receiving vaccine. Dizziness continues currently. Was ill the entire weekend after injection.
Large red circular spot below injection site. Red area is approximately 3in in diameter, hot to touch, sensitive and hard.
pt recvd vax 7JUN93 & 9JUN93 pt devel mumps w/a fever of 39.5; No further details were provided;
A non-serious spontaneous report of gave H1N1 LAIV to a 59-year-old was received from a nurse concerning a 59-year-old female. On 29-Oct-2009, the patient received single dose H1N1 2009 MONOVALENT Vaccine Live, Intranasal. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
she?s had blood clots and has had surgery 3 times, she is unconscious at the moment. the whole left side of her brain has been removed and she is paralyzed on the left side. this is definitely from the shot.
Patient received Typhoid vaccine on 02/13/2006 in right arm puritis, erythema, edema, increased pain, macular rash.
SEVERE CHILLS STARTED AY 3:00 AM FOLLOWED THEN BY NAUSEA, VOMITING, DIZZINESS AT 4:00 AM. THESE SYMPTOMS LASTED FOR A FEW HOURS.  CHILLS, FATIGUE AND HEADACHES LASTED FOR MORE THAN 24 HOURS AFTER BOOSTER SHOT. HEADACHES AND FATIGUE LASTED FOR MORE THAN 3 DAYS.
Patient has had muscle soreness in flu shot arm since date of vaccine.  He saw his orthopedic doctor and they said he had a deltoid muscle injury. He has been using ice and diclofenac for pain.
c/o generalized itchy; 50mg benedryl PO given. c/o throat and tongue swelling; 0.3mg epi IM admin and EMS called. handoff EMS
Regular symptoms; A little redness in her arm with swelling which became bigger with time; A little redness in her arm with swelling which became bigger with time; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), ERYTHEMA (A little redness in her arm with swelling which became bigger with time), PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time) and VACCINATION COMPLICATION (Regular symptoms) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Regular symptoms). On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 28-Aug-2021, the patient experienced ERYTHEMA (A little redness in her arm with swelling which became bigger with time) and PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), ERYTHEMA (A little redness in her arm with swelling which became bigger with time), PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time) and VACCINATION COMPLICATION (Regular symptoms) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant product use was provided by the reporter.   No treatment medications were reported.
ADACEL shot given right arm 2/15. 2/17, soreness at site, lump at site of injection, warm to touch, swollen. Temp 99'.
allergic reaction; Itching in the tongue; White blisters; General malaise; the child was crying; This spontaneous report was received from a consumer via Pfizer, regarding to a 4-year-old female patient. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On an unspecified date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). Also the patient received an unspecified measles vaccine.     On an unspecified date, the patient experienced a severe allergic reaction (hypersensitivity). Also, since the vaccination, when the patient ate some things, she developed itching in the tongue (itching), white blister (blister), general malaise (malaise). Additionally, since an unspecified date, the patient was crying (crying). By the time of report, the outcome of severe allergic reaction, crying, malaise, blister and tongue pruritus was unknown.  The reporter did not assess the relatedness between the severe allergic reaction, crying, malaise, blister and tongue pruritus and varicella virus vaccine live (oka/merck)(manufacturer unknown).
In evening of 11/3/07, pt noticed itching & hives on upper body & face.  No breathing or swallowing difficulty.  Seen in ER and Rx'd w/ Benadryl.
Hot red itchy swollen rash (COVID arm) on arm lasting 5 days. Minimal discoloration of skin remaining after 5 days but swelling and itching resolved.
Localized redness warmth at injection site noticed 2 days after injection. Also reports cough and vomiting.
Fine tremors in hands and feet, constant, 8 days following vaccination, paroxysmal generalized body jerking. Also nocturnal. Body jerks resolved in 4 days without treatment, fine residual tremor still persist in hands.
Red swollen arm, painful. 5 days after vaccine arm is still red and swollen. patient had headache and body aches.
Information has been received from a consumer mother concerning her 24 year old daughter with no pertinent medical history or drug/reactions and allergies who in December 2006, was vaccinated with her first dose of Gardasil (lot# unknown). Concomitant therapy included medication for migraine headaches. In February 2007, the patient was vaccinated with her second dose of Gardasil 0.5mL IM in the deltoid muscle and developed flu like symptoms. Medical attention was not sought. The reporters daughter plans on receiving the third dose. At the time of reporting the patient recovered. Additional information has been requested.
Patient is a DNR, currently tolerating BiPAP.  Started on IV steroids, bronchodilators.  Respiratory panel negative for influenza, positive for COVID-19.  Sputum culture ordered.  Check urine antigens for Legionella and strep.  Empiric treatment for CP with azithromycin and cefepime.
Dizziness, upset stomach, Sensitivity to light and sound. My face began to tingle and so did my extremities. My eyes began to bulge and I felt very tired but my face especially felt different.
This spontaneous report was received from a pharmacist, referring to a 25 year old female patient, who was non-pregnant and had human papillomavirus infection since an unspecified date. The patient's concomitant therapy, drug and allergy history were not provided. On 04-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, lot number L040054, expiration date 26-DEC-2017, for prophylaxis (strength, dose and frequency were not reported). On 05-NOV-2017, the patient had her menstrual cycle, which was two weeks earlier than she expected. It was also reported that she had always had "very regular" menstrual periods, so she felt that getting her menstrual period earlier than expected was abnormal for her. Treatment was not given and lab diagnostics or studies were not performed. The outcome of menstruation irregular was reported as not resolved. The causality assessment between the event and GARDASIL 9 was not provided.
Area of injection is sore, "like any shot". No lump or bump, area warm or red. SQ injection given as IM.
Sudden onset of intense rush of heat through body, intense increase in heart rate and inability to swallow,  trembling and shaking.  Employee was in car, returned to hospital ER.  ER administered fluids, and diphenhydramine.
Pt recvd a series of 3 Engerix-B vax 14JUL90, 13AUG90, & 28JAN91 & was a non-responder;