chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history included being diabetic. The patient did not have any drug reactions or allergies known by reporter. No concomitant medications were reported. On an unknown date, the patient was vaccinated with a 0.5 ml dose (also reported as "one shot") of PNEUMOVAX 23 (route of administration, lot# and expiration date were not reported). On an unknown date, reported as "the day after" vaccination, the patient experienced soreness at the injection site. It was unknown whether the patient sought medical attention. No lab diagnostic studies were performed. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
SEVERE NOSE BLEED, after 45 mins it stopped. 1-2 days later 2nd nose bleed, and so on to a total of 6-7 nose bleeds. It was severe.  the nose bleed was mixed with mucus, tilted back of head and it went away
Onset dizziness when turning to the left or going from  laying to sitting / standing. Does not occur sitting to standing; Onset dizziness when turning to the left or going from  laying to sitting / standing. Does not occur sitting to standing; This is a spontaneous report from a contactable nurse (patient).  A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number not provided), via an unspecified route of administration on the left arm on 26Dec2020 10:00 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history included psoriasis.  Concomitant medications included adalimumab (HUMIRA) and famotidine (FAMOTIDINE).  It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 26Dec2020 17:00, the patient experienced onset dizziness when turning to the left or going from laying to sitting / standing but does not occur sitting to standing. The patient did not receive any treatment for the events. Outcome of the events were not recovered.   Information on the lot/batch number has been requested.
Arthralgia, Fever, lymphadenopathy unilateral  Narrative:   Other Relevant History:
Abdominal muscles pain only in left side; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history included lactose intolerant. Concomitant medication included pseudoephedrine hydrochloride; cetirizine hydrochloride (ZYRTEC D) for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. On 23Mar2021 at 11:00, the patient experienced abdominal muscles pain only in left side. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event abdominal pain. The clinical outcome for the event abdominal pain was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a medical assistant via a company representative referring to a patient of unknown age and gender with an unspecified cancer. Drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) (Medication error). Concomitant drug was not reported. On an unknown date the patient developed shingles. Outcome of shingles and the relatedness between shingles and ZOSTAVAX were unknown. Additional information has been requested.
Case number PHHY2015US134239 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 572838) on 05 Oct 2015. This report refers to a 53 year female patient. Her current conditions included rheumatoid arthritis (RA) and celiac disease. Her concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) on an unknown date. On an unspecified date after vaccination, the patient experienced hives and swelling. The events outcome, seriousness and causality were not reported. No further information was provided.
syncope; autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Following vaccination, in 2013, the pt experienced syncope, orthostatic intolerance, autonomic dysfunction, fatigue, headache, and dizziness. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.  Upon internal review, Syncope was considered a medically significant event.; Sender's Comments:  US-009507513-2301USA006946:
Patient was given an expired Moderna vaccine lot # 041C21A expired on 11/1/2021. Clinical went by the label expiration date, which was sent to us with the vaccine shipment. Some of the labels were printed with wrong expiration date. Clinician gave vaccine then tried to click administer and that is when she caught the error. Database didn't let her click administer and a window popped up stating she was giving an expired vaccine.
Felt like I had a fever but I didn't.  Achy muscles, run down, tired.
REDNESS, SWELLING, EGG SIZED LUMP AT INJECTION SITE.  EXAMINED BY MD.  GAVE ZYRTEC.  TOLD PATIENT TO START ANTIBIOTICS IF SIZE OF LUMP INCREASED.
Arm is red (about 2 inches at this time), warm to touch, knot in arm, very sore. I am treating it with cold press and moving often. The area has increased in size since last night (it was about an inch). I do not feel sick. This is the same reaction I have had in the past when I would take the regular flu shot.  This is not intolerable.
Body ache; Fatigue; Chills; Sweat; missed period over a week and is still missed which is unusual for me; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16May2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Apr2021 at 14:00 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced body ache, fatigue, chills, sweat, missed period over a week and is still missed which is unusual for the patient, but all other side effect only lasted two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body ache, fatigue, chills and sweat were resolved on 18May2021 and the clinical outcome of the event missed period over a week and is still missed which is unusual was not resolved at the time of reporting.   Information on lot/batch number has been requested.
Pin point rash progressed to cover most of body in 7 days. Began to resolve 3/27/03. Almost completely resolved by 3/31/03. Accompanied by H/A, extreme itching, no fever. 3/18/03, 10am approximately 29 hrs after vaccination, pt presented with diffuse rash extending primarily over face, neck, trunk and thighs. Rash was very red, fine (pin point) and itchy and progressed over the next several days to the arms, axillae, legs, ankles and genitalia. He did not have fever, respiratory symptoms, or myalgia at any time. Pt noted a cropping aspect to the rash where it improved in the evenings, then was worse the next day when tiny painful scabs formed over the pin-point rash (no notable vesicular or pustular stage). Rash was accompanied by persistent headache lasting throughout the period of rash. Pt was treated in the ER on 3/18 with 150mg Prednisone and 150mg Benadryl immediately after rash was noticed. A closer review of medical history included the following: past allergies to "-zines," such as Compazine, dust, mild and guinea pigs. His TST always displayed erythema without induration; he can eat seafood (saltwater) but can't eat fresh fish (freshwater). Freshwater fish causes systemic anaphylaxis with the following symptoms: itching, tongue,  lip and pharyngeal swelling. Pt had been taking antibiotic Clindomycin until 3/19 or 3/20 ro cervical lymphadenitis. A TST was administered at same time as the vaccinia vaccination (3/17/03). The rash first appeared and first cleared in the face, neck and chest. The rash last appeared and last cleared from his axillae. He received limited relief from diphenhydramine, hydroxyzine and cimetidine. On 3/25/03 pt was given Doxapin x 1 for extreme itching and related distress. On 3/26/03 pt felt much better and seemed to "turn a corner" and get better over the next few days. His rash was 99% resolved by 3/31/03 per pt. Residual skin discoloration/scarring on trunk (4/18/03).
The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022; Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna COVID19 vaccine 10 days after the 30-day use-by-date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The vial was initially stored in the refrigerator on 10-Jan-2022 and administered on 18-Feb-2022. It was reported that the vial had not undergone any temperature excursions.   This case was linked to MOD-2022-500959 (Patient Link).
Pt recvd MMR vax & w/in 24 hrs to 48 hrs following vax pt devel t103 w/enlargement of occipital lymph nodes; sx resolved next day; approx 10 to 14 days following vax; devel small pinpoint rash primarily on chest & trunk;
Patient received vaccine. Patient then sat down for the required 15 minutes. Patient got nauseous and went to the bathroom. After several minutes in the bathroom, patient passed out or fainted and fell on the floor. Patient was able to get up with help from our associates. Patient then was able to leave on her own.
Encephalopathy, decreased consciousness, immediate warm rush sat. Syncope, (Slow moving, pressure on ears, unable to focus on task on hand, easily confused, short term memory loss, trouble focusing eyes, left whole let and foot tingling, personality change, agitated, back of head felt like it smacked hard as in a fall. Symptoms very bad x2 days, third better, ok in one week.
3 pm uncomfortable but still awakening to feed but seems to suckle for comfort but not making gulping sounds or emptying breasts felt warm to touch ax temp 99 7 pm 101.9 temp ax Nurse advised take to ED due to chapped lips, sunken fontanel decreased wet diapers IV bolus and TYLENOL given in ED, labs drawn.
MODERNA COVID-19 VACCINE EUA  ;  BODYBONE PAIN, FEVER, CHILLS, HEADACHE, VOMIT, TIRENESS, INJECTION SITEHARD/SWOLLEN/HOT, LETHARGIC FOR 14.5 HOURS (FELT LIKE I DID WHEN I HAD COVID19 IN OCTOBER); SYMPTOMS EASED UP AFTER 24 HOURS.. I AM CONCERNED ABOUT GETTING SECOND DOSE
Initial report received from the patient on 28 April 2011 via a Company-sponsored web site. Follow-up information received the following day via telephone contact to the patient. This is a case of misuse where the patient received 2 doses of Tdap vaccine 10 months apart. A female patient (date of birth not reported) had received a dose of Tdap vaccine (trade name, manufacturer name, lot number, route and site of administration unknown) on 25 February 2011 in the ED (emergency department) following an accident (type of accident not reported). The patient had received a dose of Tdap 10 months prior. At an unspecified amount of time after receiving the Tdap on 25 February 2011, the patient reported having swollen joints in the feet and knees requiring an ED (emergency department) visit where she was treated with 40 mg of prednisone. Per the patient, some tests (not identified) are pending. At the time of this report, the patient had not recovered. Documents held by sender: None.
Ongoing gum bleeding, abnormal nails, continued bleeding after recent OB GYN visit
Case number PHEH2013US024300 is an initial spontaneous report received from a nurse on 18 NOV 2013 and a follow up report from the nurse received on 10 DEC 2013. This case refers to female patient of unknown age. Past medical history and concomitant medication were not reported. She was vaccinated with expired FLUVIRIN 2012/2013 (batch number: 1207101 and expiry date: JUN 2013) at dose of 0.5 ml in the right arm intramuscularly on 15 NOV 2013. No adverse event was reporting following this administration error.   Follow up report from the nurse received on 10 DEC 2013., Patient initials and site of vaccination was updated.
WAKE UP FEELING BURNING ALL OVER THE BODY; HAD NOT SLEPT IN WEEKS DUE TO ITCHINESS; EXHAUSTION; ALLERGIC REACTION; SEVERE SUDDEN RASH ALL OVER THE BODY (BOTH ARMS, BOTH LEGS, TORSO, BACK AND SHOULDERS BUT MOSTLY ON THE UPPER BODY) WHICH THE DOCTOR WAS REFERRING TO IT AS AN ALLERGIC REACTION WITH ECZEMA,; OLD POLIO VACCINE SCAR ON THE LEFT SHOULDER HAS BLOWN UP AND BLISTERED; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with polio vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021, the patient experienced severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema. On 07-JUL-2021, the patient experienced old polio vaccine scar on the left shoulder has blown up and blistered. On 07-JUL-2021, the patient experienced allergic reaction. On 10-JUL-2021, the patient experienced had not slept in weeks due to itchiness. On 10-JUL-2021, the patient experienced exhaustion. On 14-JUL-2021, the patient experienced wake up feeling burning all over the body. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from old polio vaccine scar on the left shoulder has blown up and blistered, exhaustion, wake up feeling burning all over the body, severe sudden rash all over the body (both arms, both legs, torso, back and shoulders but mostly on the upper body) which the doctor was referring to it as an allergic reaction with eczema, had not slept in weeks due to itchiness, and allergic reaction. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
On June 4, 2022 I had cough and slightly elevated temperature, I took a home test and it was negative. On 06/05/2022 my symptoms got worse and I had an appointment to be at on 06/06/2022 so I tested and it was immediately positive. I contacted my doctor on 06/06/2022 and received a prescription for Paxlovid from her. I have now finished my medication and having no muscle aches or fever still having a little bit of cough. I did test this morning and it was a faint positive line.
Nauseous starting approximately 17 hours after shot; still nauseous 15 hours later
No adverse event- expired vaccine administered 06/09/2023. Expiration date 06/06/2023
Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD21-087488, US-MODERNATX, INC.-MOD-2021-109680 (E2B Linked Report).; Sender's Comments:  MOD21-087488:crosslink-wife US-MODERNATX, INC.-MOD-2021-109680:
Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad). At the time of the report, FEELING ABNORMAL (Feeling bad) outcome was unknown. Not Provided          No concomitant and treatment medications information was reported. The patient feeling bad post second dose.
The day after the first dose, my knee had swollen to the size of a grapefruit. I was unable to walk for days, and required the use of crutches. After two weeks I visited an orthopedic doctor who was going to drain my knee and give me a Cortizone shot, but chose not to when he realized I was scheduled for a second dose to in two weeks. With little-to-no improvement, my doctor scheduled a surgery. Assessment: torn Medial meniscus, loose body (5 x 8 mm) notch, medial tibial spine osteophyte ( 8 x 8 mm), arthritis right knee
This is a spontaneous report from a contactable consumer who reported 2 cases, this one of the 2 cases. A 66-year-old female patient received PREVNAR 13 (Lot# R12276, Exp date Feb2018, NDC 0051971-02), via an unspecified route of administration in left deltoid, on 20Jan2017, at 0.5 ml single, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 30Jan2017 with outcome of unknown, redness on 24Jan2017 with outcome of unknown and swelling on 24Jan2017 with outcome of unknown. Therapeutic measures were taken as a result of cellulitis and included treatment with KEFLEX.
The day following my inoculation with flu vaccine (above) and polio vaccine (S51635 X10/18) I was unable to move. I ached all over, got out of bed with great difficulty, was unsteady walking in my apartment, could not engage in my usual activities or eat, found it difficult to lower myself onto the toilet seat and spent much of the next 24 hours in bed for the relief of just lying down or napping.  Although I did not detect a fever through hand on forehead, I seemed to be very heated internally, my breath came up very hot. The next morning I had lost two pounds but in every way felt energetic and fine, back to normal, taking my usual exercise class, walking outside at least 4 miles to shop. I have been getting the flu shot every year for many years and have never had such a reaction.
received the second shot in the other arm at six weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second shot in the other arm at six weeks apart) had resolved.            No concomitant medication was provided. No treatment information was provided.  The patient had no problems after receiving the second dose.   This case was linked to MOD-2021-306141 (Patient Link).
Information has been received from a registered nurse concerning a 4 year old female with no medical history and no allergies who on 03-AUG-2007 was vaccinated with a first 0.5ml subcutaneous dose of PROQUAD (Lot #