chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2017, the patient was vaccinated with a dose of ZOSTAVAX for immunization (dose, route, lot # and expiration date were not reported). It was reported that after vaccination the patient experienced infection around the injection site. It was stated that the patient went to her physician's office and was treated with an unspecified antibiotic. At the time of reporting the outcome of the event was reported as fully recovered. A product quality complaint was not involved. The causality assessment between the adverse event and ZOSTAVAX was not provided. This is one of two reports from the same reporter.    Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004653:
Had temp to 103 48 hours after and with continued redness upper arm > one week with no sign of infection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus-like auto immune disorder" (unspecified if ongoing).  No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2023) Negative, notes: tested covid negative 3 days after completing  Paxlovid, Covid rebound symptoms 5 days after finishing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headache, Arthralgia, trouble moving right arm, chills/sweats Narrative:  Other Relevant History:
Within 24 to 48 hours, the pt developed an elevated red knot measuring 4 cm to 5 cm at the injection site, and severe nausea and headache which resolved within 3 days.
Arm is hurting; Arm is hard to bend; A spontaneous report was received from a consumer concerning a 29-year old, female patient who received Moderna's COVID-19 vaccine and experienced arm is hurting and arm is hard to bend.   There were no medical history and concomitant medications reported.  On 28 Dec 2020, approximately 6 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH # 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Dec 2020 at 6:30 pm, the patient reported experiencing pain in her left arm and difficulty bending the arm. This pain is located on the left arm in the middle muscle between area between the shoulder and elbow and right in the middle, per the patient, and was still ongoing at the time of report.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm is hurting, and arm is hard to bend, were unknown.; Reporter's Comments: This case concerns a 29-year old female who experienced nonserious events of arm is hurting and arm is hard to bend. The events occurred approximately 6 hours after she received the first of two planned doses of mRNA-1273 (Lot # 037K20A). The patient's past medical history and con meds were not provided. Very limited information regarding these events has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.
Mild to severe headache, bulls eye rash at injection site; bullseye rash on chest, left side.  Treatment - Tylenol.
***Please ignore 2nd vaccine listed. Dont know how to delete it. Only recieved 2nd dose covid 19 vaccine on 6/30*** Heart inflamation with chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat.
Extreme fatigue.   Body aches, joint aches, muscle aches.   Feeling of being very sick.  Chills and nausea
Patient admitted with submassive PE requiring thrombectomy. He did not have acute respiratory failure but did have RV strain. His SEROVITAL supplement was evaluated by endocrinology and not determined to increase risk of thrombus. He did have a mild left calf strain, but insufficient provocation found for VTE
Pt received ZOSTAVAX on 1/6/16. Pt came in on 1/10/16 - saying arm - hurt. Arm more red and slightly swollen and warm to touch. Advise pt to take BENADRYL and be seen by MD to rule out infections. Pt already applying ice.
worsening symptoms; continued soreness and pain on the arm; numbness on the arm; Feverish; nausea; pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;; soreness in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish) and NAUSEA (nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ASCORBIC ACID, BIOTIN, TOCOPHERYL ACETATE (BIOTIN GUMMY) for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (soreness in the arm). 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;). On 29-Apr-2021, the patient experienced PYREXIA (Feverish) and NAUSEA (nausea). On 12-May-2021, the patient experienced HYPOAESTHESIA (numbness on the arm). On an unknown date, the patient experienced CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm). The patient was treated with IBUPROFEN for Pain, at a dose of 800 milligram three times a day. At the time of the report, PAIN (soreness in the arm), HYPOAESTHESIA (numbness on the arm), VACCINATION SITE PAIN (pain on the arm where he was injected the second dose of the Moderna Covid-19 vaccine;), PYREXIA (Feverish), NAUSEA (nausea), CONDITION AGGRAVATED (worsening symptoms) and MYALGIA (continued soreness and pain on the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-138849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up document uploaded on 21-MAY-2021, Events updated.
36 y/o/m presents with tingling/numbness and tightness to arms and feet that came on today. Recently seen for dehydration a couple of days ago after walking for a long period of time in the sun. After that episode he was having trouble ambulating and does not have muscle control. He states since then he has been relaxing and sleeping but continued to feel the tightness in his extremities.  Having a harder time speaking. He was able to eat and drink normally. No pain. Denies vomiting. He continued to become weaker over the course if the following day and was crawling.  LP was performed and CSF studies revealed high protein and normal cell counts, surmised to be consistent with Guillain-Barre or variant. IVIG was started via PIV on the evening of HD 1.  On HD 2 he was assessed to be generally weaker, breathing faster (RR in 20s), phonating less well, swallowing weaker, and having more trouble managing his secretions. He was stepped up to ICU for monitoring. IVIG was continued.  After two days, weakness was stable/mildly improved and he was stepped down. Patient finished 5 days of IVIG therapy on 7/24. Slow recovery of strength. Pt had asp episode on 7/23 and required BiPAP. CXR showed RLL infiltrate. Empiric Rocephin started for 5-day course.
RASH DEVELOPED ON LOWER PORTION OF NECK AND BACK, SIMILAR TO THAT OF A ZOSTER INFECTION.
suicidal during most of 2020 and 2021 because of the isolation; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was concerned about increase in price for the COVID vaccine, because not enough people were vaccinated already. No concomitant product was reported. Patient received Moderna COVID-19 vaccine before 2021 in a study. She thought that she got the actual vaccine sometime in October and she was in the placebo group before that. She was suicidal during most of 2020 and 2021 because of the isolation. No treatment information was reported.; Reporter's Comments: Company comment: This spontaneous case concerns an adult female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Suicidal ideation which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Latency cannot be determined as the date of vaccination and onset of event are not reported. Other details are not available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report
4 days after second short arm of shot ballooned such that no features can be distinguished.    Visited Doctor twice but they had not seen anything like this. They ordered scan on left arm for possible blood clots; negative.  Prescribed Benadryl every 8 hours, taken for thee days but no relief from sever swelling.   It is now 7 days since the arm first swelled up.
Slight chills; Joint pain; Gastrointestinal gas; Gastrointestinal cramps; Looser stool; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 09Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alfuzosin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took 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 19Mar2021 at 18:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 10Apr2021 at 12:00, the patient experienced slight chills, joint pain, gastrointestinal gas/cramps and looser stools. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event's slight chills, joint pain, gastrointestinal gas/cramps and looser stools was unknown at the time of this report.    No follow-up attempts are needed. No further information is expected.
Diarrhea; Stomach is upset; He's got a cold; On-and-off fever; Chills; Runny nose; Body aches; Hot-and-cold sweats; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0162) dose 2 via an unspecified route of administration on 22Apr2021 as single dose for covid-19 immunisation. Medical history included single functional kidney (one kidney absent). The patient's concomitant medications was not reported. Historical medication included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: not provided) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunization. The patient experienced diarrhea, his stomach is upset, he's got a cold, on-and-off fever, chills, runny nose, body aches, hot and cold sweats. Patient asked how long do these last. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Around 9pm on date of vaccine severe chills, teeth chattering, nausea, headache. Saw HCP. Next day PT felt no better. Went to two urgent care that would not see her.  Went to Med center. She had severe back pain and ringing in her ears at this point. They left her in a room for 30 minutes to go consult with a doctor after she told them she had the J&J vaccine. They came back and told her she had fluid in ear from pollen and back pain was caused from the chills and shaking. She still has a sharp pain in her ear and ringing in ears is still present.
pt recv vax 23JUL98 & 29JUL98 pt devel fever & abd pain;appendicitis was r/o p/a work up;pt is still sick;
On 11/10/98, sudden onset of loss of feeling right side of face with right sided facial muscle paralysis. Dx as Bell's palsy. Treated with tapered course of oral Prednisone. Symptoms improved gradually over the next several months. Still with residual symptoms that when tired.
Patient diagnosed with COVID19 After full vaccination.  Vaccinated 2/12/21 and 3/921.  Symptom onset 5/9/21.  Symptoms included fever, chills, fatigue.  Symptoms are improving as of 5/13/21, not yet resolved.
PATIENT RECEIVED SHINGRIX VACCINE ON MORNING OF 12/19/19 AND DID EXPERIENCE MUSCLE SORENESS ON SAME NIGHT.  THE FOLLOWING MORNING PATIENT HAD RASH IN SAME ARM BUT NOT AT INJECTION SITE.  PATIENT TOOK UBER TO HOSPITAL WHERE SHE WAS ADMITTED FOR 3 DAYS.  SHE WAS TREATED WITH ANTI-VIRAL.  BOTH PATIENT AND HOSPITAL BELIEVE REACTION WAS NOT FROM VACCINE BUT SOMETHING SHE MAY HAVE CAME IN CONTACT WITH.  PATIENT WAS TREATED WITH VALTREX 1000MG BY MOUTH THREE TIMES A DAY FOR 7 DAYS.
In April 2023, I had a cough and mucus. I went to the urgent care clinic and I was told it was allergy or viral.  I was given a ZPack and cough syrup. The next Monday I was not getting better and went to the doctor. I received TRELEGY and a nebulizer with Albuterol. Those two seemed to work. As of today, I still cough up mucus, but it may just be allergy related. I was unable to breath properly before and now I am better.
sore arm where the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm where the needle went in) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for Paracetamol.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm where the needle went in). At the time of the report, VACCINATION SITE PAIN (sore arm where the needle went in) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As per client on 05-Aug-2021, MI error in DOB capture as --1-JAN-1900   Reporter did not allow further contact
Lump in my arm at the injection site. Couldn't see. Seizure at home. Another seizure at ER. High blood pressure.
3-1 11:35 AM patient stated slightly itchy, no treatment, observe for longer duration. 3-1 11:40 AM patient stated feeling better, cannot stay any longer need to get to program. 3-1 12:10 PM patient did not complain of any sym/signs until she saw me. 3-2 Pt came into pharmacy and said she needed to go to ER for hives, BENADRYL.
Information has been received from a licensed practical nurse concerning a 4 year old female with a history of occasional otitis media and no known drug allergies who on 01/04/1999 was vaccinated with the first dose of varicella virus vaccine live, SC in the left thigh. Concomitant therapy included unspecified antihistamines and decongestants as needed. On 02/26/2002 the pt developed chicken pox with approximately 20 lesions and a temperature that ranged between 99-101deg F. The pt was treated with Benadryl as needed. It was reported that the pt recovered after five days. It was also noted that the pt and her siblings did not have any adverse events following prior vaccinations. The pt sought unspecified medical attention. The nurse also reported that the pt's brother developed varicella post vaccination with varicella virus vaccine live (WAES0202USA02799). No further info is expected.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned an 82 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 30-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309987, 20220309972, 20220310363, 20220310548, 20220310590, 20220310306 and 20220310631.
Patient presented to our primary care office 10 days after her Pfizer COVID booster shot was administered.  She started with hives over her torso, arms and legs the day prior which was 9 days after her booster vaccine.  Patient was placed on benadryl and pepcid for urticaira.  Her symptoms progressed over that day with difficulty breathing, vomiting and syncope.  She was taken to the emergency department.  She was observed and placed on 5 days of oral prednisone.  SHE DID NOT REQUIRE ANY EPINEPHRINE and was observed in the emergency department for hours prior to discharge.  Symptoms resolved fully.
Received a varicella vaccine on 10/4/23 in the left arm, posterior upper arm. Had redness and swelling this AM on left arm, about a quarter in size at 0830. At 0930 the swelling increased to about the size of a palm, with patient report of itchiness when touched. Redness was warm to touch. While walking down to employee health, was experiencing slight shortness of breath. Brought back to room by RN. Employee health APP and MD to room to assess.  Gave Benadryl IM, vital signs stable, took cab home
Patient received 2nd Hep A & 1st VARIVAX in office on 2/4/13. In less than 5 minutes after immunizations given patient turned pale, eyes rolled back into head & he passed out. Did not regain good color, no palpable pulses in extremities. He regained consciousness with a 1 minute color poor vascular collapse until epinephrine was given.
rash; itchiness; Severe joint pain; nausea; stomach pain; This is a spontaneous report from a contactable Other HCP reported for herself. This 32-year-old female (no pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on 19Dec2020 18:45 at single dose for COVID-19 immunization. Medical history included Auto immune disorder, high-risk medications, asthma, and allergies: Spectrum hand sanitizer. Concomitant medication included adalimumab (HUMIRA) received within 2 weeks of vaccination. No Covid prior vaccination, No Covid tested post vaccination. No other vaccine in four weeks. On 19Dec2020 11:00 PM, the patient experienced severe joint pain, nausea, stomach pain the same day as vaccine. The next day (on 20Dec2020) patient experienced rash and itchiness. No treatment received for the events. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Patient is a 94 y.o. female with CKD 3, hypertension, mild cognitive impairment who presented to the hospital for evaluation of abdominal discomfort and loss of appetite.  Her son has been home sick with COVID-19 infection, approximately 3 days ago she developed abdominal discomfort across her abdomen and has had poor appetite with little to no oral intake since that time.  She denies nausea, vomiting, diarrhea.  She is not short of breath or coughing.  She has received x2 doses of Pfizer COVID-vaccine and has not yet had her booster.  SPO2 89% documented in the ED; at the bedside her oximetry has a poor pleth, when she holds still and has a good waveform she is persistently 97-100%; patient remains on 2L NC, desatted to 83% eating breakfast without oxygen.
Pt. states on 11/30/09 that she has rash and itching at site of shingles vaccination. Started on 11/19 and continues. Rash hard to visualize. She visited physician office-nurses there recommended Calamine lotion during the day and Benedryl at night.
AXILLARY ADENOPATHY, NECK SWELLING, THYROID ENLARGEMENT, PROGRESSIVE WITH SECOND DOSE, LONG-LASTING, EASY BRUISING
pt c/o tingling in B/L arms and head. pt stated she was a "bit" dizzy at first but sx subsided. Pt sat in view of Rn for extended time period. VS 198/108 HR92 SPO2 97. Pt VS rechecked BP 148/90 SPO2 97 HR 94 pt stated she felt better. Pt ambulated independently, RR even and unlabored, NAD noted, Skin NFR. Pt declined transport to ED.
Ten minutes post vaccine, I developed pulsitile tinnitus. The pounding was very harsh and frequent for months, and has slowly been decreasing. However, I still have pressure in my ears and periods of the pounding as well as ringing tinnitus.