chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache at the base of my skull; Face pain; Heart racing with minimal movement/heart palpitations; Fatigue; Significant increase in pre-existing tinnitus; Overall feeling of "not feeling well".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jun2021 09:15 (Lot number: EW0187) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D3; B12 [CYANOCOBALAMIN]; L-LYSINE ACETATE. Vaccination history included: Bnt162b2 (Product- COVID 19,, Brand-Pfizer,, Lot Number- EW0183,, Lot unknown- False,, Administration date- 16May2021,, Administration time-01:00 PM,, Dose number- 1, Vaccine location- Left arm), administration date: 16May2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Headache at the base of my skull"; FACIAL PAIN (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Face pain"; PALPITATIONS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Heart racing with minimal movement/heart palpitations"; FATIGUE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Significant increase in pre-existing tinnitus"; MALAISE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Overall feeling of "not feeling well".".  No follow-up attempts are possible. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included Heart valve replacement. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMINS NOS for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Right side of his face was numb), DIZZINESS (Dizziness), ASTHENIA (Weak all over), RASH (Rash) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use included blood pressure medications. No treatment details were provided.
This spontaneous report as received from a nurse refers to a 17 years old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Severe itching for several days on torso upper legs and arms followed by rash outbreak yesterday 03/17/2021
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not reported) one year ago, in approximately August 2011. No other co-suspects were reported. No concomitant medications were reported. On 27-AUG-2012 the patient was getting the second dose of GARDASIL. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Pt had an episode of syncope. He was sitting in his car at the time and did not fall or hit his head. He momentarily lost consciousness but came to after being  physically tapped on shoulder.  He reported having similar episodes when he has had his blood drawn. EMS was contacted and his blood pressure was 70/40 and pulse was 90. EMS was unable to get a blood glucose reading, Pt fully recovered and was picked up by his wife.
The adverse event is that the patient is 17 years of age and the Moderna vaccine is only recommended for those ages 18 and above.  At the time of completing this report patient has not had to seek any treatment or has had any issues.  The patient did sit the whole 15 minutes after receiving the vaccine and did not have any concerns when he left.
Pt reports fever, chills and body aches that resolve when she takes Tylenol, but return when she does not take Tylenol. Onset started day after vaccine received.
Coughing, not sure about fever has no way to check, NO sob, nausea and has not eaten, head congestion, body aches (can not lay in bed without being in pain), Sinus pain and pressure, and has a sinus headaches and it is here whole head and feels like her head is in a vise.
24x11 cm Redness and Swelling Extending Below the Elbow with Pain.
Dural venous sinus thrombosis left and L internal Jugular vein thrombosis, caused severe headaches, causing patient to be hospitalized for management and treatment.  hospitalized for 5 days for IV anticoagulant before being discharged on Pradaxa
Joint pain, nausea, migraine, blurred and distorted vision, confusion, fatigue, chills, memory, severe disorientation, loss of motor skills
1 of 4 pts vaxed from the same lot exp an adverse event; pt exp h/a, & stomach cramping w/in 24 hrs following vax; treated w/APAP; pt recovered;
Baseball size red, warm, swollen area left arm, treated with cool compresses and Benadryl.
acute cystitis with hematuria; hematuria; neuralgic pain; periorbital cellulitis; 6th nerve palsy of the left eye; high suspicion of shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 12-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a painful burning sensation to the right lateral mid and right mid anterior torso. The patient was diagnosed with acute cystitis with hematuria and neuralgic pain, with high suspicion of shingles. Shortly thereafter, the patient's left eye started to have pain and swelling and she was diagnosed with periorbital cellulitis and 6th nerve palsy of the left eye.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, 6th nerve paralysis and periorbital cellulitis were determined to be medically significant.
Narrative:  Covid + complicated by dementia/depression, Pfizer 2/19/21 and 3/12/21-2 separate admits 10/13-received remdesivir in ED, d/c home and 10/19/21-observation only, d/c home
Just started getting short of breath and lightheaded. Diagnosis with irregular heart beat and enlarge heart. I had to have a pacemaker put in.
Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination.  Medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name.  She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a nurse practitioner who heard that a female who was vaccinated with a dose of hepatitis B virus vaccine (manufacturer unknown) and had an unspecified "allergic reaction". At the time of the report, the patient had recovered. Additional information has been requested.
Information has been received from a physician concerning a 6 year old male who on 8/3/1999 was vaccinated with a dose of varicella virus vaccine live. The patient reported to the office on 3/10/2005 with about one dozen pox. The mother noted that he was exposed to real chickenpox. No prescription was necessary. No product quality complaint was involved. The patients brother (WAES0503USA04739) also had Varicella after vaccination with varicella virus vaccine live. Additional information has been requested.
The patient received the smallpox vaccine on 5 Feb 2003.  Patient complained of muscle pains in the shoulders and legs.  Also noted fatigue and nausea.  Symptoms began 1 day after having vaccine.  The patient responded after 2 days to rest, fluids, and tylenol.
Shortness of breath, feels like esophagus is closing in; Weakness; Aches; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nausea). On 12-May-2021, the patient experienced DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath, feels like esophagus is closing in), ASTHENIA (Weakness), PAIN (Aches), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved.            No relevant concomitant medications were provided.  The action taken for mRNA-1273 was not applicable.
THE PATIENT COMPLAINED ON 10/21/2020 TO ME AT THE PHARMACY THAT SHE HAD PAIN AND NUMBNESS AT THE INJECTION SITE THAT STARTED THE NEXT DAY AFTER THE IMMUNIZATION. SHE ALSO SAID THE NUMBNESS THEN WENT TO HER FINGERS AND FEET IN THE FOLLOWING DAYS AND  WEEKS. SHE VISITED HER DOCTOR ABOUT IT.
Site of injection is sore, red, itchy, slightly warm, and swollen. Soreness and swollen feels similar to the day I got my shot.
RACING HEARTBEAT; DIZZY; CHILLS; WEAKNESS; HEADACHE; FEVER; MUSCLE ACHE; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced racing heartbeat. On 01-APR-2021, the subject experienced dizzy. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced weakness. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced muscle ache. On 01-APR-2021, the subject experienced nausea. On 01-APR-2021, the subject experienced fatigue. Laboratory data included: Heartbeats increased (NR: not provided) 144 /min. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) 21 BMI. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from racing heartbeat, weakness, fever, muscle ache, and nausea on 02-APR-2021, and headache on 03-APR-2021, was recovering from chills, and had not recovered from fatigue, and dizzy. This report was non-serious.
An 18 month old female pt, with no past medical history, had received a SC, left arm, third dose injection of Ipol, lot number Y1051; an IM, left arm, fourth dose injection of Tripedia, lot number U1387CA; and an IM, right arm, first dose injection of hep A vaccine, lot 0511F; on 20Jun06. Twenty four hrs later, the pt experienced swelling of her hands and feet. She had no pitting edema and no edema elsewhere on her body. The event required a doctor's visit. At the time of this report, the pt had recovered.
Headache, nasal congestion, Dry mouth, dizzy, muscle ache, body ache, fever
Information has been received from a RN concerning a pt who between 22Oct04 and 25Oct04 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot647655/0869N). Subsequently, the pt experienced an injection site reaction. Unspecified medical attention was sought. The pt recovered. It was also reported that 4 out of 5 pt's (WAES0410USA04112, 0410USA4303, 0410USA04304) have had reactions after receiving pneumococcal 23v polysaccharide vaccine from the same vial. The doctor questioned the vial and lot number since all doses were from the same one. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
received 2nd dose today, received 1st dose more than 6 months ago; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on October 2020).   On 21st January 2022, the patient received the 2nd dose of Shingrix. On 21st January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient self-reported the case. The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Greater than 101 degree F fever within an hour, vaccine injection site Pain/Swelling. Arm swelling and decreased range of motion. Upper chest pain.
Approximately seven days following vaccination, the pt developed elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase). The pt sought unspecified medical attention. No further information is available.
c/o increased anxiety/panic attack.  Syncopal feeling after Covid-19 Vaccine.  Refused transport to ER
Numbness in leg; Numbness of limbs; Flu like symptoms; Chills; Ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in leg), HYPOAESTHESIA (Numbness of limbs), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache). On 28-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in leg) and HYPOAESTHESIA (Numbness of limbs). At the time of the report, HYPOAESTHESIA (Numbness in leg), HYPOAESTHESIA (Numbness of limbs), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and PAIN (Ache) outcome was unknown.
covid arm that is not going away down to her elbow; Red; Hot; Peeling; Burning; Night sweats; Throat dry; Can't really eat; Mouth dry; feels like there are blisters in her mouth; Nauseous; Mild fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm that is not going away down to her elbow), ERYTHEMA (Red), FEELING HOT (Hot), SKIN EXFOLIATION (Peeling) and BURNING SENSATION (Burning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021, 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 SITE REACTION (covid arm that is not going away down to her elbow), ERYTHEMA (Red), FEELING HOT (Hot), SKIN EXFOLIATION (Peeling), BURNING SENSATION (Burning), NIGHT SWEATS (Night sweats), DRY THROAT (Throat dry), DYSPHAGIA (Can't really eat), DRY MOUTH (Mouth dry), BLISTER (feels like there are blisters in her mouth), NAUSEA (Nauseous), PYREXIA (Mild fever) and CHILLS (Chills). At the time of the report, VACCINATION SITE REACTION (covid arm that is not going away down to her elbow), ERYTHEMA (Red), FEELING HOT (Hot), SKIN EXFOLIATION (Peeling), BURNING SENSATION (Burning), NIGHT SWEATS (Night sweats), DRY THROAT (Throat dry), DYSPHAGIA (Can't really eat), DRY MOUTH (Mouth dry), BLISTER (feels like there are blisters in her mouth), NAUSEA (Nauseous), PYREXIA (Mild fever) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Received notification from pt, reporting "a pretty good local reaction to my flu shot that I got yesterday.  It don't hurt.  My whole delt is swollen and itches so bad.  I have had issue with preservatives before but my concern is maybe its related to my alpha gal.  I have alpha gal and read the insert that said this vaccine has Madin-Darby canine kidney cells. By the time I got to my car it felt itchy but I just thought it was my shirt or something.  It just got worse and by the evening my delt was a little swollen.  By the next morning my full delt on right side was twice the size warm to touch and still felt itchy."  She reports she call PHN left message on number, and also messaged the nurse case manager.  She reported she took Benadryl 50mg, placed a cool pack, takes Zyrtec daily and swelling is much less today.  She reports "I got the shot Tuesday.  I don't have egg allergies.  I have a sensitivity to preservatives but staff told me it was preservative free.  The only thing I can think of is the MDCK.  I have never reacted like this to a vaccine or medication injection.  I have been more sensitive in recent months to mammalian products.  I just don't want to have a worse reaction/anaphylaxis with next one.  At first I just thought it was a normal local.  As it got worse I started asking questions about the vaccine because it was the only thing different and that had been in or on that delt.  I was hoping it was just a latex bandage but it didn't start getting better until I took the benadryl."  Pt denied seeing provider. Observed vaccine was administered on 10/18/2022 in the clinic.
The area around the shot is large, puffy and hurts. I'm worried it might be infected.
Patient received the Janssen COVID-19 vaccine on 7/17/21 at roughly 4:35 pm and shortly after felt hot, sweaty, and faint. Patient was given apple juice and laid on the floor for several minutes before feeling much better. She was then able to leave on her own.
day post vax-sore throat;chest congested-coughing up green phlegm;
pt recv vax & from the time of shot until 4AM pt cried, screamed intermittently; 25AUG 4AM dry heaves, very pale, legs went limp, staring, jerky, talking weird;  25AUG026AUF fever 101  only tx APAP;