chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient unknown age. On 16-OCT-2013, the patient was vaccinated with ZOSTAVAX VIAL 19400 PFU (dose, route and lot number were not provided). No concomitant medications were reported. On 16-OCT-2013, the patient received less than full dose of ZOSTAVAX when the needle came loose from the syringe during administration and some of the ZOSTAVAX leaked out. No adverse symptoms reported. Additional information has been requested.
Rapid Response team called for C/o  dizziness, lightheadedness, weakness and numbness in all 4 extremities. She was admitted to ED
Pale, dizzy, almost fainted, use ice packs behind neck, got better in 10 min.
expired doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses were administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses were administered) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.   This case was linked to MOD-2021-354462, MOD-2021-354659 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received: Added Patient details.
Shoulder pain and loss of range of motion starting right after vaccine administration and still present after 1 month.
Flu like symptoms; Fever; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms), the first episode of PYREXIA (Fever) and the second episode of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced the first episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the first episode of PYREXIA (Fever). In August 2021, the patient experienced the second episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the second episode of PYREXIA (Fever). In August 2021, last episode of INFLUENZA LIKE ILLNESS (Flu like symptoms) and the last episode of PYREXIA (Fever) had resolved.            Concomitant medication was not reported.  In 2021, patient received 1st dose COVID-19 vaccine manufactured by Moderna. In 2021, patient received 2nd dose COVID-19 vaccine manufactured by Moderna. On 18-Aug-2021, patient received 3rd dose COVID-19 vaccine manufactured by Moderna. The patient had Moderna twice a month apart in 2021 and stated that most of them with Rheumatoid arthritis taking a biologic qualify for the third booster as immune suppressed. The patient got a note from Rheumatoid arthritis doctor stating that and four days ago on 18-Aug-2021, the patient got their third Moderna booster. Symptoms experienced were like the second shot. The patient had flu like symptoms and a slight fever for 24 hours. The patient glad they did this and still were a mask when they were in crowds. Treatment details were unknown.  It was unknown if patient was enrolled in a COVID-19 vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
24OCT97 nausea, dizziness, thought process was inhibited, could not form complete sentences, disoriented, thought & coordination severely inhibited for day;
syncope; fell from standing; hit head on table; This is a spontaneous report from a contactable health professional. A 27-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EW0164), intramuscular in the left arm on 15Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccinations within 4 weeks of the vaccine. On 15Apr2021, immediately after the vaccine, the patient experienced syncope due to which he fell. He fell from standing and hit his head on a table. There were no signs of soft tissue injury. The patient was brought into the emergency department from the vaccination room. The patient was not treated for the events. The clinical outcome of syncope, fell from standing and hit head on table was resolved on Apr2021.; Sender's Comments: A contributory role of  BNT162B2 to the reported events cannot  be excluded based on temporal association.  Case will be reassessed if additional information is received.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Lymph-node pain under arm (same as injected arm), radiated from underarm to under left breast; duration from 04-03-2021 through 04-07-2021  Metallic taste in mouth.  Intermittent from day of injection to current date of this report (04-20-2021).
Varicella vaccine 10/12/95. Acute onset varicella with > 50 pox in first 24 hrs on 11/4/02.
Hot flashes; Diarrhea; Vaccine was administered too high in the upper arm; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal disorder and Pain. Concomitant products included ETODOLAC (LODINE) for Pain.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Feb-2021, PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm) had resolved. At the time of the report, HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided  by reporter.   Reporter did not allow further contact
Fever; Initial information received on 11-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves an adult patient (unknown age and gender) who had fever (pyrexia), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fever (pyrexia) (unknown latency) following the administration of INFLUENZA VACCINE.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
blood in stool with less amount; diarrhea (7-8 times) with signs of bright red blood; Lower abdominal cramping; extreme pain; severe abdominal pain/cramps; extremely tired/ little exhausted feeling comes and go; body weakness; slept all day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ASTHENIA (body weakness), SOMNOLENCE (slept all day) and ABDOMINAL PAIN LOWER (Lower abdominal cramping) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Prostatic disorder. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, LISINOPRIL for Blood pressure high, TAMSULOSIN for Prostatic disorder.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go). On 21-May-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), ABDOMINAL PAIN LOWER (Lower abdominal cramping), PAIN (extreme pain) and ABDOMINAL PAIN (severe abdominal pain/cramps). On 22-May-2021, the patient experienced HAEMATOCHEZIA (blood in stool with less amount). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at a dose of OTC, 2mg. On 06-May-2021, ASTHENIA (body weakness), SOMNOLENCE (slept all day) and FATIGUE (extremely tired/ little exhausted feeling comes and go) had resolved. On 22-May-2021, PAIN (extreme pain) had resolved. At the time of the report, DIARRHOEA HAEMORRHAGIC (diarrhea (7-8 times) with signs of bright red blood), HAEMATOCHEZIA (blood in stool with less amount), ABDOMINAL PAIN LOWER (Lower abdominal cramping) and ABDOMINAL PAIN (severe abdominal pain/cramps) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 06May2021, patient got blood work done. No results was given. Patient was in an extreme pain from 7pm and it last all night This case is linked case to Original Case : MOD-2021-162193 Action taken with mRNA-1273 in response to the event was Not Applicable  Very limited information regarding the events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events have been provided at this time. Further information has been requested.
swelling  where  shot was  given and could not lift my arm for 2 days. Nausea for 2 days and really tired.
Took unrefrigerated dose of Vivotif; Spontaneous report received on 06FEB2020.  A male consumer reported that he "took unrefrigerated dose of Vivotif" (PT: Product storage error). He was receiving Vivotif for immunisation. The consumer finished his last dose of Vivotif but, the vaccine was exposed out of the refrigerator for a total cumulative time of 16 hours. He could not confirm the temperature. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of  product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took unrefrigerated dose of Vivotif (Product storage error). Vivotif was exposed out of a refrigerator for a cumulative time of 16 hours and Vivotif should always be stored inside refrigerator at recommended temperature. Considering the nature of the event, the causality of  product storage error is assessed as not applicable to Vivotif.
Excruciating pain in right shoulder; zero mobility. Patient said, this is the worst pain I have ever experienced in my entire life. Improved slightly over 72 hours.
One day post vax, the pt experienced pain, redness and swelling. The pt described a raised area approximately 5-6 across. The second day the pt experienced a temp of 102. Pt took Tylenol but did not seek medical care. The pt also reported nausea.
Right thigh where she receive DPaT/IPV has been turning red and swollen some itching(?). Tenderness noted.
Information has been received from a medical assistant concerning a 17 year old female who on 16-JAN-2008 was vaccinated with a second dose of GARDASIL vaccine (yeast). The patient developed a rash, unspecified, after the second dose and went to an urgent care center but was not hospitalized. The doctor's office was notified of the rash when the patient was called by the doctor's office on 17-JUN-2008 to schedule her third vaccination. The doctor's office is awaiting records. At the time of the report, the outcome was unknown. Additional information  has been requested.
c/o severe burning in arm p/vax;2min later c/o chest pain;SOB, fainted shortly afterward;BP 90/56-P57;woke w/bad h/a that cont until the following day;
Pt started vomiting and complaining of severe abdomen pain. Was seen in the ER twice for abdomen pain. Dr.'s counldn't find anything wrong other than constipation. She was also seen twice by pediatrician who couldn't find anything wrong with her. Constipation problem was taken care of and pt still was screaming in pain. Pt didn't sleep for 2 weeks because of extreme pain. After 2 weeks a Dr. diagnosed her as having an allergic reaction to the MMR vaccine b/c of her previous egg allergy. She can no longer have eggs or milk b/c it causes severe pain and bloating.
This case was reported by a healthcare professional via a sales representative and described the occurrence of bulging Fontanelle in a 4-month-old subject of unspecified gender who was vaccinated with PEDIARIX. Previous and/or concurrent vaccinations given on the same day as PEDIARIX included Haemophilius influenzae type B vaccine, manufacturer unspecified; pneumococcal vaccine, unspecified; manufacturer unspecified. On an unspecified date the subject received 2nd dose of PEDIARIX. At an unspecified time after vaccination with PEDIARIX, the subject experienced bulging Fontanelle. The subject required medical attention in the physician's office. It was unknown if the bulging Fontanelle was a congenital anomaly / birth defect. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event possibly related to vaccination with PEDIARIX. On 11 February 2008 follow-up was received via the healthcare professional. She reported that the 4 month old male subject received the first dose of PEDRIX on 16 October 2007 and the second dose of PEDIARIX on 07 January 2008. Concurrent vaccinations given on the same day as PEDIARIX included ROTATEQ, oral route, manufacturer unspecified, along with Haemophillus influenzae type B vaccine; manufacturer unspecified, pneumococcal vaccine, unspecified; manufacturer unspecified. On 07 January 2008, the subject experienced an inappropriate schedule of vaccine administered. Three days following vaccination with with PEDIARIX, on 10 January 2008, the subject experienced a bulging Fontanelle and an unspecified adverse reaction. The subject was seen by the physician. A spinal tap and unspecified laboratory tests were performed and all results  were normal. The healthcare professional noted that the events were not serious and she considered that the bulging Fontanelle and unspecified adverse reaction were possibly related to the use of PEDIARIX. The healthcare professional noted that the bulging Fontanelle  was not associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent via medicinal product. On an unspecified date, the bulging Fontanelle and unspecified adverse reaction resolved.
Beginning the day after the vaccination pt states her arm was sore and swollen. Pt continues to have soreness and a golf ball sized lump at the site of the vaccination one year later. Pt states physician recently prescribed Diclofenac sodium topical 1% gel and that has relieved the pain but not the swelling.
Patient states he had mild to moderate discomfort in my L arm (injection location), it has continued for approximately 12hrs, along with my hands feeling numb and cold, patient  also felt a bit lightheaded.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after getting the booster shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she's 73 y/o and she has Covid after getting the booster shots. Clinical course: Caller wants to know where she can get the medication Paxlovid. Was not able to transfer to PRIVATE, caller disconnected the call. Created a manual AE form. Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information: YES: Customer and/or medical inquiry forwarded or referred to MI. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received Pzifer vaccine, and was seated in the waiting area, flagged down a nurse, and c/o feeling lightheaded, and stomach cramps. Pt moved to enclosed area, resting on stretcher, and vitals taken, initials vitals 90, 130/79, 97%. Declined N/V. pt stated that he had not eaten during the day. tolerated clears.  Pt rested for 15 minutes, next set of vitals 69, 120/80, 99%.  Pt denied the need to go to ED, and left for home.
I had the Vaccine on 1/25/21, in my Right Arm.  I started having symptoms on 1/26/21, I worked half a day and went home with Chills, Joint pain, Headache and missed work on 1/27.  I had joint pain in my fingers and toes, but continued to work, I tried Tylenol with the pain, On 2/3/21 while at work I got the COVID Arm symptoms, Hot arm, Red rash, Huge hard knot, ( I put an Ice pack on the site while at work and took Tylenol)  I also have had more joint pain in my Fingers and Toes causing me to stay home from work on 1/4 and 1/5 and again on 1/8 and 1/9.  The Burning and Sharp pain in my fingers, toes (swelling in my toes on my Right foot) and wrist have not gone away.  I have been woken up from the Sharp pain in my fingers and toes, it is uncomfortable wearing shoes.  I still have the COVID Arm, the red rash the Hot and the swelling of my arm, the heat comes and goes in my arm, the red rash has been continuous since it first appeared, the knot has shrunk in size.
suicidal thoughts; depression; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (age at vaccination was 41 years) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer, lot: ER2613) in left arm on 17Mar2021 17: 00 at a single dose for COVID-19 immunization. Vaccine Facility type was hospital. Medical history was none. Allergies to medications, food, or other products was no. Patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELAXA) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that 2 days post shot on 19Mar2021 09:00, she began to have suicidal thoughts. She did suffer from depression, but she was not suicidal and have never been treated for this level of depression before. 2 1/2 weeks later her mood has improved. She did not harm herself. Events were considered non-serious. The outcome of the events was recovered. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID 19.
Called 9/27/2012 reported palms of hands and bottom of feet itching. Denies any other rash. No fever. No shortness of breath - used topical cortisone and allergy med ALLEGRA x 1 resolved in 10 days.
This spontaneous report was received from a medical assistant, refers to a 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of PROQUAD (lot # M043306, exp. date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored under temperature from -14 degree Celsius (C) to -10 C with timeframe of 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of 11 reports received from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-1708USA001338: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820.
1324h COVID vaccine administered  1338h pt reported wheezing, difficulty breathing to nurse who notified MD 1339h pt reports h/o CHF, MD advised pt to take his nitro 5 mcg, pulse ox 88% 1341h no improvement of sx, MD administered EpiPen 0.3 mg/0.3 mL, L lateral thigh, 15L of 02 administered by rebreather mask, pulse ox 98% 1347h BP 148/84 1349 diphenhydramine 50mg IM administered by MD, L arm 1351h paramedics took over care of pt, transported by ambulance to nearest hospital