chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pneumonia; COVID on April 2nd, 2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia) in an 83-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Apr-2023, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (COVID on April 2nd, 2023). On 26-May-2023, PNEUMONIA (Pneumonia) had resolved. At the time of the report, COVID-19 (COVID on April 2nd, 2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2023, Chest X-ray: still showed pneumonia. On 26-May-2023, Chest X-ray: that showed he was cleared of the pneumonia..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. It was reported that patient got exposed to COVID on 30-MAR-2023 and got COVID on 02-APR-2023 during a trip. Pneumonia was diagnosed. It was reported that after four antibiotics patient got over it by 26-MAY-2023.  Company comment:  This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious (medically significant)  event of Pneumonia and non-serious event of COVID-19. The events occurred about 7 months after the administration of mRNA-1273 BIVALENT .222 vaccine, used as a fifth dose. Two chest x-Rays were done with about one month in between showing current and posterior resolution of the pneumonia. It was not reported if pneumonia was secondary to current COVID-19 infection. No further information on clinical course or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 BIVALENT .222 Vaccine is not affected by this report.
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 09Jan2021 as dose 2, single (Lot number: ET1686), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 12May2022 at 12:00 as dose 4 (booster), single (Lot number: FJ1685) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sesame, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Adverse event: Rebound Covid. Recovered quickly while on Paxlivid tested negative on day three. Initial main symptoms were sore throat and body aches and fatigue. four days after completing packs with it she had a little bit of a sore throat then the next day had a profound runny nose and tested positive. she had major sneezing congestion body aches and headaches. I tested negative on day six  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event, vaccination failure and Covid 19 and the role of suspect drug cannot be ruled out. The case will be reassessed once new information is available.
autoimmune disorder which is Poly myalgia Rheumatica; having discomfort in my shoulders/started started noticing discomfort in hips and thighs; mostly about discomfort in lower extremities; Could not even get out of my bed at one point a; Joint pain; A spontaneous report was received from a physician concerning himself, a 65-years-old, male patient who experienced joint pain, having discomfort in my shoulders, started noticing discomfort in hips and thighs, mostly about discomfort in lower extremities, autoimmune disorder which is poly myalgia rheumatica and could not even get out of my bed at one point.   The patient's medical history included neurological issues. Concomitant product use was not provided by the reporter.  On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 lot number 012L20A for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient reported discomfort in his shoulder and discomfort in his hips and thighs. Patient found out that it was an autoimmune disorder which was polymyalgia rheumatica.  Treatment for the event included high dose steroid.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of all the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Extreme menstrual irregularity and menorrhagia. Start of symptoms on April 12 cut short average 28-29 day cycle to only 21 days (March 22 to April 11). Cycle starting April 12 began with 6-day period, and full cycle only lasted 10 days ? including 2 days of spotting during the 4 non-period days. Following cycle began April 22 with a 6-day period, but full cycle extended to 32 days. Following cycle began May 24 with a 12-day period with extreme heavy bleeding, and full cycle was short at only 23 days. Most recent cycle began June 16 and currently on Day 10 of an extremely heavy period. On Days 7-9 of the current period, I would estimate blood loss of at least 70-100 grams each day, given usage rate of feminine hygiene products.
Information has been received from a physician concerning a patient who 3 weeks ago on approximately 12-MAR-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced a local injection site reaction after the vaccination was given. The reaction was 2 inches in diameter. Medical attention was sought, the patient spoke to the nurse. It was unspecified if lab studies were performed. The reaction lasted for 2 days. The patient recovered on approximately the 14-MAR-2008. There was no product quality complaint involved. Follo up information was received which reported that the physician had no additional infomation. Additional information is not expected.
Vaccine given - obs x15 w/o complaint. Shortly after c/o frontal H/A - Sec r/s, no paleness, no dizziness. Obs x30 min w/o change. Spoke with mother via phone. Hx of H/A for varied reasons - nothing specific.
pt recvd vax 20FEB96 & devel nausea, vomiting & h/a the next 2 days;swelling painful lt upper arm @ inj site noted;
Flu shot administered in the AM on 10/24/2006 at NIOSH by the facility nurse. Around 2:30 pm patient felt light headed, tightness in chest, sore ribs, lymph node soreness, stiffness in neck, tightness of throat and headache. As of 7:20 PM patient is lying down and still complaining of chest tightness. States does not feel well at all.
Transverse myelitis and resulting paraplegia, urinary retention, bowel incontinence. No definitive cause identified despite a very thorough work up and treatment. Suspect vaccine as a probable cause. Treatment included high dose IV steroids, several rounds of plasmapheresis, IV acyclovir without improvement in symptoms. Currently still paraplegic, inpatient rehabilitation with unknown prognosis.
soreness of the upper arm where the injection site occurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Soreness of the upper arm where the injection site occurred"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Soreness of the upper arm where the injection site occurred". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness of the upper arm where the injection site occurred".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201296760 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296757 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296758 same patient/event, different vaccine doses/event;US-PFIZER INC-202201296272 same patient, different vaccine doses/event;
Information has been received from a physician via a company representative referring to a 80 years old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot# were not reported) to prevent shingles. On 08-AUG-2015 the patient experienced an "outbreak of varicella". The patient went to an unspecified urgent care facility for medical attention. The patient was treated with prednisone and sent home. The outcome of the event was unknown. Causality was not reported. Additional information is not expected because the physician would not like to be contacted.
Took Zostavax, since then the shingles outbreak has increased every 4-5 weeks vs. 2-3 times a year.
Initial unsolicited report received from a consumer on 26-Dec-2015. This case involves male patient (age was not reported) who was vaccinated with a dose of ACAM2000 (manufacturer: Sanofi, batch number was unknown and route was not reported) in the left arm on an unspecified date. Patient illness at the time of vaccination was reported as unknown. Other medical history and concomitant medications were not reported. On an unspecified date after vaccination (reported as few days ago), patient had a cut in his right finger then touched the smallpox site. The right finger was swollen and "infected looking". He also touched his eyes which got itchy, red and swollen. He went to the ER in his town. He felt that his symptoms were worsened. Patient required ER/doctor visit. Lab tests were not reported. Patient received pain medication in emergency room. Patient had not recovered from the events and advised to go back to the ER. Upon internal review, case was considered as serious due to important medical events: infected looking finger, right finger swollen, itchy eyes, swollen eyes and eye redness. Documents held by sender: none.
Client called and stated she had difficulty breathing with wheezing started in the even after receiving the flu shot.  She stated that she also broke out in hives and rash the following day.
Patient received Pfizer COVID vaccine out of state on 2/6/21 and 2/27/21. On 9/5/21, patient admitted to our facility for acute hypoxic respiratory failure due to COVID pneumonia. As of 9/9/21, patient is in CCU sedated on BiPAP.
A non-serious spontaneous report of uncontrollable laughter, uncontrollable crying and pupils were constricted has been received from a nurse/health professional concerning a ten-year-old male, subsequent to H1N1, Intranasal. No medical history was reported for this patient. The patient's concomitant medications included amphetamines. On 15-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 15-Dec-2009, five minutes after vaccination the patient had an uncontrollable laughter with crying at the same time, and patient's pupils were constricted. The outcome for the reported events was unknown.
infection; A spontaneous report was received from a 65 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed infection (infection).   The patient's medical history was not provided. Concomitant medications included glipizide.  On 09-FEB-2021, 8 days prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (lot#: 025L20A) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.    On 16-FEB-2021, the patient developed infection and was subsequently hospitalized for three days. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, infection, was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Since the vaccine on that date I have been experiencing a feeling of my finger on my left hand feeling swollen,  and when I bend my fingers they sometimes get lock in that bend position., for a short period. Systems are still goi g on today.
made me sick; have a cold from time to time; Initial information received on 16-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) whom made sick (illness) and cold from time to time (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   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 fell sick (illness, non-serious) and cold from time to time (nasopharyngitis, non-serious) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Some people would drink manure tea if told, have not had a flu shot in over fifty years, the one I had made me sick and other who got it were sick too, I may have a cold from time to time but not the flu, must not really work cause they keep pushing one every year."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There would be no information on the batch number for this case.
Patient walking through waiting room after receiving flu immunization. Patient felt faint - eyes rolled back in head per mother. Placed in lying position then hydrated with water after faintness resolved. Assisted to sitting position. Doctor notified and examined patient.
pt was exp back pain @ the time of vax;the back pain worsened post vax;
This patient received a ZOSTAVAX immunization in Nov. 2009 and experienced an adverse reaction consisting primarily of significant pain in the area of injection that persistent in the area of injection for ten moths according to the patient. The patient characterized it as carrying a leaden weight. The pain slowly improved and was a non-factor until 12/20/15 when she noticed a dull aching sensation in exactly the same place with progression of a rash that resulted in a clinical diagnosis of shingles on 12/21/15. There was no blistering or itching. The distribution was the C5 dermatome of the left arm. She was treated with acyclovir and otc analgesics. The pain in now only a dull ache and doing well. I have previously reported the first part of this case to Medwatch (no, I don't have a file number).
Muscle pain in arm; arm red; "no reflexes in legs"; "severe muscle pain".
About 45 minutes after injection I had tingling lips, the first inch of my tongue felt numb, and when I licked my lips there was a tinny, metallic taste.  These symptoms lasted approximately 15 minutes. I was able to swallow and drank water.
PATIENT REPORTS HAVING SIGNIFICANT ALOPECIA SINCE VACCINE.  PATIENT REPORTS NO OTHER CHANGES AT THE TIME.  INCIDENT REPORTED TO MYSELF (SHOT ADMINISTRATOR 7/8/2019)
Pt. received COVID-19 vaccine on 06/05/21 and developed a mild fever on 06/06/21, but had not had a fever since that day when coming to the ED on 06/10/21. On 06/07/21 while the pt. was at school pt. became dizzy and  pupils dilated. Pt. was picked up from school and rested for 3 hours and she did not remember how she got home or how she got to the school nurse..Pt.in ED for similar symptoms 6/7/21 and 6/9/21 before coming again on 06/10/21 with a negative work up. Pt. has been on school zoom meetings and has been looking at pillows and thinking they are people and they were moving and talking to her. Pt. walking into walls, trouble walking and intermittent confusion and multiple episodes of conversations that she does not recall and time periods which she can not remember. Pt. was transferred to a higher level of care in another facility.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient without a pertinent medical history or drug reactions/allergies. On 22-MAY-2013 the patient was vaccinated with ZOSTAVAX (vial, lot # H019092, 0.65 ml once, subcutaneous in the left triceps). Concomitant therapies included NEXIUM, simvastatin (manufacturer unknown) and estradiol (manufacturer unknown). On 24-MAY-2013 the patient experienced a "tennis ball size red area" on the back of her arm at the injection site, the area "does not hurt all the time but tender when touched, the area is itchy and the area is warm to touch". The patient sought medical attention by seeing the pharmacist. No treatment was given for the events. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. Additional information has been requested.
On 08/13/2000 the patient developed an eruption of chickenpox which continued to appear 7 to 3 pox each day until 08/24/2000. It was noted to be itchy. On 08/15/2000 the patient was seen in the physician's office to confirm chickenpox and was noted to have a few red bumps. Follow up information received 09/27/2000 from a physician indicated that on 08/30/2000, the patient recovered. No further information is expected.
One week after receiving the shot I woke up with a swollen left arm where the shot was given. It was moderately sore. Then I developed a rash near the site of the injection. I took one Benadryl on 1/13/21  which did not help. The infectious disease doctor recommended I take Claritin. I took one on 1/14/21. The rash  subsided and swelling decreased.  On 1/15/21 I took another Claritin and the redness and swelling  had mostly cleared.
Vaccines given 5/29/07 and "blistering" rash appeared on L back and L abdomen on 5/30/07. Exam consistent with Herpes Zoster
died 2 days after the second vaccine; This is a spontaneous report from a contactable consumer reporting for his/her father. An 87-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and was fine. The patient died 2 days after the second vaccine. The reporter stated patient death due to the Pfizer Covid vaccine. The patient had autopsy. The outcome of event was fatal.   Information about lot/batch number has been requested.; Reported Cause(s) of Death: died 2 days after the second vaccine
at 25th hr after receiving vaccine, pt caregiver reports high fever, nausea, diarrhea, chills and hot flashes. inquired about taking tylenol and caregiver reports patient is unable to-reports extreme nausea
Severe chills was initial symptom, followed by moderate temperature (99 - 103), general fatigue & body ache, loss of appetite.  Symptoms sustained for 48 hours.
Same day post vax, the pt began to have an upset stomach. The next day, the pt vomited at noon and again about 2 pm. He also had a low grade fever.
Diarrhea and vomiting for 28 hours - started 4 hours after receiving vaccine.
pt recv vax  17OCT97 by MD w/low grade fever 101, not eating, congestion & cold s/s;MD is reporting this as a vaccine rxn;pt had DTP/HIB/OPV between 1115 & 1210 15OCT97;fever 99.5 & cold s/s;motrin brought temp down from 102;;
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 09-AUG-2013, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The VARIVAX (Merck) had been stored at -10 C (Celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Left upper arm red, swollen, hot to touch starting on Sat. By Monday, redness is much better, itching improving, chart note attached.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Given epipen after allergic response in waiting area in pharmacy 0.3 mg dose called 911 pt was consious when left , she gave medical history to rep that she is diabetic
Patient is an 80-year-old man with past medical history of RLE DVT on Coumadin who is fully vaccinated with Pfizer SARS-COV-2 Vaccination in 02/2021, presented with 7 days history of generalized fatigue, malaise and lethargy as well as cough.  Patient was seen in urgent care where he tested positive for COVID-19.  Patient was found to be hypoxemic saturating 87% on room air, with temp of 39.3°.  Chest x-ray was patchy opacification of the right lung base.  Given hypoxemia, patient was admitted and started on Decadron.  Patient's respiratory status significantly improved and remained stable off oxygen.  Patient was able to ambulate in his room without any difficulty.  Patient was provided with dexamethasone prescription at discharge.  Patient received dexamethasone during the hospital stay but was discontinued at the time of discharge.  INR was therapeutic and patient was advised to resume warfarin per home regimen. Patient was discharged to Home without services in stable condition.