chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He also has Diarrhea for the last 5 days; Rash after booster; Swollen esophagus after booster; Acid reflux after booster; Itchy all over body, mainly in the bottom of feet and hands and groin area after booster; Hives after booster; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and DIARRHOEA (He also has Diarrhea for the last 5 days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A, 01DM20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, the patient experienced OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster) and RASH (Rash after booster). On 15-Jan-2022, the patient experienced DIARRHOEA (He also has Diarrhea for the last 5 days). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Oesophageal inflammation, at a dose of UNK, prn. At the time of the report, OESOPHAGITIS (Swollen esophagus after booster), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux after booster), PRURITUS (Itchy all over body, mainly in the bottom of feet and hands and groin area after booster), URTICARIA (Hives after booster), DIARRHOEA (He also has Diarrhea for the last 5 days) and RASH (Rash after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had visited the doctor and was given a Steroid shot and pack treatment. And was also prescribed with Zyrtec, Benadryl liquid PRN for esophagus.  Concomitant medication information was not reported
On 06/08/21, I felt dizzy and fainted hours after I received the second dose of Pfizer COVID-19 vaccine.   On 06/11/21, I started experiencing shortness of breath  On 06/12/21, I continued to have shortness of breath and felt swelling on the left chest and felt the shape of my heart. On 06/12/21 evening , I checked into ED, lab was drawn, chest xray, CT chest was completed. CT showed right lower lobe pulmonary embolus extending  into multiple segmental branches. On 06/13/21, I was started on blood thinners
On Sat. 12/1/18 pt. came to pharmacy and reported 2 issues: 5 days of soreness in L arm (injection arm), starting day of injection, reaching down to elbow area. This has resolved as of today 12/1. No further soreness or pain. No medical treatment by patient, she reduced activities involving sore L arm. L arm injection site itching and redness. Pt. presented today 12/1/18 with redness and inflamed area beyond injection site, roughly a 4"x6" area of redness, with warmth to the touch. Pt reports this started afternoon of 11/30 and continues today, duration about 20 hours as of this report. Pt showed Clotrimazole Cream as OTC treatment "because I had it at home and it said for itching." I recommended pt. use Hydrocortisone Cream (OTC) as better treatment option, and report to pharmacy or medical provider for further evaluation if condition worsens with time.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 05-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Information has been received from a woman concerning her 7 year old female relative with asthma, reflux and an allergy to a liquid medication for reflux who on 08/16/1995 was vaccinated with the first dose of varicella virus vaccine live IM. There was no illness at the time of vaccination. Concomitant therapy included Ritalin, Advair, montelukast sodium, bethanechol CI, Prilosec, Zyrtec and Sudafed. On 02/03/2002 the pt "came down with 40-50 lesions." Follow-up info reported that the lesions were chicken pox lesions on the trunk. The pt had no complications and was treated symptomatically with no diagnostic tests or labs performed. No further info is expected.
short of breath; wasn''t feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "short of breath"; MALAISE (non-serious), outcome "unknown", described as "wasn''t feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the blood work was unknown results.  The lot number for bnt162b2 was not provided and will be requested during follow up.
REDNESS, SWELLING, HOT, PRURITUS ON AREA OF VACCINE INJECTION.
Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; Palsey on left side.  Watering left eye.  Numbness on left side around mouth and cheek.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 29Mar2021 10:00 (Batch/Lot number was not reported) at the age of 51 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included warfarin taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline hydrochloride (DOXYCYCLIN) and experienced allergy. The patient previously received first dose of bnt162b2 on 09Mar2021 09:00 AM at the age of 51 years old for COVID-19 immunization (vaccine location: right arm). No other vaccines received within 4 weeks prior to COVID vaccine. On 05Apr2021 07:00, the patient experienced Palsy (palsey) on left side, watering of left eye and numbness on left side around mouth and cheek. No treatment was received for the adverse events. The patient recovered from all the events on unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  Information on the lot/batch number has been requested.
Extreme fatigue beginning 7 hours post vaccination (booster #2). Fever, chills. Fatigue continued for 36 hours post vaccination. Armpit swollen & painful. Experienced similar symptoms post booster #1.
MODERNA COVID VACCINE WAS GIVEN OFF LABEL.  THE MANUFACTUER AND BUREAU OF IMMUNIZATIONS WERE CONTACTED AND THE PATIENT REPORTS NO ADVERSE REACTIONS.
No adverse event.  15 year old received Booster dose & is under the approved age of 16 and up to receive booster.
pt recvd vax & on 17NOV94 pt exp 2 szs;f/u from the MD indicated that pt had 2 episodes of passing out, but an EEG was neg for sz activity;pt recovered;
Vaccine admin on 12/29/11. On 1/07/12 developed low grade fever & red raised area noted to left upper arm. Fever x 2d, then resolved. Red raised area decreased in size within 2 days. Pt currently has fine red rash on face, trunk & legs. See attached note. Came w mom, (L) upper arm raised area (got varicella in that arm). No has rash. Of note: has previously been referred to allergist due to hx of erythema multiforme/urticaria evolving over 3 days 1 weeks after being in AUGMENTIN for otitis. Was subsequently demonstrated to have metapneumovirus infection.
Lymphadenitis; Lymphadenopathy in her axila; Injection was not properly administered, it was given to low in the arm / administered in a lower part of the deltoid; This case was reported by a nurse via sales rep and described the occurrence of lymphadenitis in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced lymphadenitis, lymphadenopathy axillary and vaccine administered at inappropriate site. On an unknown date, the outcome of the lymphadenitis, lymphadenopathy axillary and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the lymphadenitis and lymphadenopathy axillary to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient was in her fifties at the time of reporting. It was reported that a patient received the 1st dose of Shingrix a week and half ago and right away developed a lymphadenopathy in her axila and lymphadenitis. The symptom was localized and it was resolved at the time of reporting.  It was mentioned that the injection was not properly administered and the patient considered that the injection was administered in a lower part of the deltoid, which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020161273:FU1 deleted
Vaccinated on 9/3/02. Did not report any problems until 9/6/02 at 11:56AM. Patient states received Hepatitis B vaccine at 4:30PM while waiting in lobby waiting on her ride. Started itching around eyes, then up forehead, about 10 minutes after injection. Cleaning lady was cleaning lobby at time. Patient did not report to anyone at health department but left department building around 7 PM. Cheeks started itching around 8-830PM. Nasal itching and swelling which continued around 12:30PM. No other swelling were noted. 9/6/02 at 12:15 itching is better today, but feels achy body, no energy; took Benadryl 75mg. Patient at 6:30PM on 9/5/02 will go to MD.
A swollen, sore spot appeared in the left armpit; Large and painful swollen lymph node; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient 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 09Apr2021 at 11:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, days after receiving vaccination, the patient experienced a swollen, sore spot that appeared in the left armpit. It was reported that the spot had continued to swell, and it was then very, very painful and continued to grow and it was then nearly the size of half a golf ball.  She had been told that it looked like a swollen lymph node, but was shocked at how large and painful it was. The fact that it continued to grow in size concerned her. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events a swollen, sore spot appeared in the left armpit was and large and painful swollen lymph node was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Swelling at injection site; Flu symptoms; Terrible headaches; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Flu symptoms), HEADACHE (Terrible headaches) and VACCINATION SITE SWELLING (Swelling at injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA (Flu symptoms) and HEADACHE (Terrible headaches). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, INFLUENZA (Flu symptoms), HEADACHE (Terrible headaches) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .Relevant concomitant medications were not provided.  Treatment medication was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Pt has a red lightly blistered rash on her face. Patient went to doctor and he gave her VALTREX 1gm. She was taking VALTREX 500mg on 03.22/2018 but indicated that she never got shingles before.
Pt was noted to have eyes roll up, then have tonic-clonic movements of upper and lower extremities. Pt was brought to ER via EMS where he was given multiple doses of Atavan and eventually dx'd as status epilepticus. Pt was in status about 2-3 hours per history.
This serious initial spontaneous case was received on 23-Nov-2017 from a Pharmacist, concerns a 16-year-old, female patient. The patient did not have medical history. Concomitant medication included Doxycycline for an unknown indication. On 09-Nov-2017, the patient was administered with influenza vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, trade name, manufacturer and expiry date: not reported). On 10-Nov-2017, one day after vaccination, the patient experienced bloody stools and her stomach hurt for 2 days. The patient did not take any treatment measure for the events. On 12-Nov-2017, the patient recovered from the events. Case  Comment:  Based  on  the  available  information,  the  company  assesses  the  events  as  related  to  vaccine  considering  the  close  temporal  relationship.  The  event  bloody  stools  can  be  due  to  any  other  medical  condition  or  infection,  but  considering  the  close  temporal  relationship  the  role  of  vaccine  cannot  be  ruled  out.  The  events  will  be  reassessed  upon  receipt  of  further  details.  The  event  haematochezia  was  considered  medically  significant.
Tightness in chest, asthma-like symptoms, congestion. Received the vaccine on 2/27 at about 5:10 and woke up the next morning with these symptoms.
5 am - sore arm - a little swollen. That evening of the second day at about 7 pm - I had body aches and a low grade fever.  The third day, I felt back to normal and my arm was back to normal. The following week, the day after I tested positive for COVID, so that was January 7th. The arm was itchy and burny. It had a big rash on that area. (January 6 My upper back was hurting really bad and I had a fever. I wasn't feeling good at all. Had shortness of breath. So I went for a COVID test.) The rash lasted for about 48 hours and then it was gone. I didn't take anything for it. My other COVID symptoms lasted for about 6 days. I still didn't have taste though. I got that back on about day 10. I had the shortness of breath (feeling out of breath) which lasted a week and a half longer than when I felt better from the other COVID symptoms.  I treated COVID symptoms with VIT C; Vit D3 and tylenol.
headache; chills; dizziness; vomiting; hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: ENG203, Expiration Date: 30Jun2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid", start date: Oct2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; VOMITING (non-serious), outcome "unknown", described as "vomiting"; FEELING HOT (non-serious), outcome "unknown", described as "hot". Additional information: The caller was calling about the Pfizer covid vaccine, the caller just had covid back in October, the 8th or something like that, it was a very mild case. The caller got the first dose of the vaccine this past Tuesday 02Mar2021. The problem was the caller got hit pretty hard with the first shot. It was not horrible, she had headache, chills, hot, no fever, she knows it's to be expected, she vomited a couple of times. The caller woke up dizzy then it went away. The caller heard that the people who have had covid were the ones who get hit with the hard punches, she was scared of the second shot because she heard it was worse than the first one. Does she have to get the second dose for immunization? The caller mentions she couldn't see anything anymore when looking at the vaccination card. Lot number captured as provided. No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a 78 year old female patient referring to herself. The patient's concurrent conditions included Diabetes Mellitus, artificial heart valve, immunodeficiency, Stage 4 kidney disease, Arthritis and drug hypersensitivity (reported as allergic to Sulfa and KEFLEX). On an unknown date in 2014 (reported as about two years ago), the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dosage, frequency and route of administration were not provided). This information was reported accordingly to the patient's chart record, however, the patient stated that she did not recall ever being administered with the vaccine. No other suspect or concomitants therapies were reported. In March 2016, the patient developed pneumonia described as she was coughing several times a day and each coughing episode would last up to 10 minutes at a time. Then she was twice admitted to the Hospital because of pneumonia complications for about 4 days in both hospitalizations. Additionally, the reporter stated that pneumonia was treated with unspecified antibiotics and an unspecified nebulizer. It was also reported that Blood work test was performed, however, the result was not provided. At the time of the report, the outcome of pneumonia was recovering as the patient stated that she was almost recovered but she still had some residual coughing and phlegm occurring. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. No product quality complain was involved. Additional information has been requested.
Minor fainted after receiving vaccines. Child was taken to emergency room due to child fainted after vaccines, child fainted and hit face. As per PCP minor was send to ER via ambulance. During ER evaluation EKG was performed and vitals are normal. Child stated pain decrease and he feels better. Dx: Fainting, Vagal Reaction. Child was discharged on 10/4/2021. No prescribed medications. Follow up with PCP in 1-2 days for reevaluation. Child is stable.
Varicella Information has been received from a physician and a school nurse concerning a 10 year old male who on 24-JUL-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 22-AUG-1995 and 06-MAY-1999. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesions. Unspecified medical attention was sought. The outcome is recovered. A product quality complain was not involved. It was also noted that the patient's brother was vaccinated with varicella virus vaccine live (Oka/Merck) and developed chickenpox (WAES#051USA08932). No additional information is expected.
Right Lymph node breast swelling; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL1283, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 for COVID-19 immunization. Facility Type Vaccine: Hospital. The patient had no relevant history and had no known allergies. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient did not have Covid prior vaccination. There was no other vaccine given within four weeks; and no other medications given within two weeks. On 19Jan2021 09:00 AM, the patient experienced right lymph node breast swelling. No treatment was given for the adverse event. The patient was not Covid tested post vaccination. The patient recovered from the event on an unspecified date in 2021.
weight loss, nausea & vomiting, malaise. 5/20/08 Office records received including vax record.  Seen for sick visit 5/01/08 with c/o nausea, vomiting, and stomach feeling whoozy x 1 month.  Impression Nausea & Vomiting. Tx with metoclopramide. Seen again 5/5/08 with c/o sore throat, nausea, back pain. Impression: N&V, Bilirubinuria, pancytopenia. Referral made to Oncologist. 07/01/2008 MR received for DOS 05/7-31/2008 with D/C DX: Acute Myeloid Leukemia. Pt presented with pancytopenia for eval to r/o acute leukemia. Bone marrow bx confirmed AML. Started on chemo which initially was well tolerated but later developed severe abdominal c/o with hematochezia.  DX with pancolitis, likely infectious. Pt had intermittent high fevers and hypotension.  Pt developed a clot in her PICC line and it was removed. Blood counts somewhat recovered and pt d/c 5/31/08.