chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling / in the lymph node in the injection arm; This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received Shingrix (intramuscular). In September 2020, 24 hrs after receiving Shingrix, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported.  The patient received Shingrix in deltoid muscle. After receiving dose of Shingrix, the patient experienced swelling of the size of a golf ball in the lymph node in the injection arm. The reporter reported that, she was not sure if the symptoms were resolved. She did not provide more details. The reporter consented to follow up.
fever, h/a, back & neck pain, malaise, sore arm beginning that noc p/vax & lasting 48 hrs;
This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 14Apr2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunization. Medical history included ongoing type 2 diabetes mellitus (Diagnosed 1 year and a half or 2 years ago), ongoing hypertension (Diagnosed 1 year and a half or 2 years ago Blood pressure was 130/90 and it used to be a lot higher), ongoing blood cholesterol (Diagnosed 1 year and a half or 2 years ago), He threw his back out (He threw his back out when he worked at a nursery in the 1980s), back pain (He has not missed work due to back pain in 15 years) ongoing Herniated disc, His A1c was 9.3, now it is down to 6.1. Concomitant medication included metformin taken for type 2 diabetes mellitus, chlorthalidone taken for hypertension, rosuvastatin taken for blood cholesterol, hydrocodone taken for an unspecified indication. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17 Mar 2021 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization and tetracycline and Got knots in his stomach. On Apr 2021, the patient experienced back ache/couple or three days after the vaccine he had pain. it was a gradual pain that got worse/he has to pick up his left leg; if he lifts it on his own it hurts his left lower back, his back was totally wrenched. he feels the vaccine aggravated an old back injury on an unspecified date, his arm was sore for one or two days on Apr 2021, his blood sugar yesterday was 144 on 29Apr2021. Patient visited physician for back pain. Patient stated he has not missed work due to back pain in 15 years. a couple or three days after the vaccine he had pain. It was a gradual pain that got worse until he had to miss work for a couple of days. States this was after the second dose of the vaccine. Says it was back pain. States it took him 10 minutes to get out of bed, his back was totally wrenched. He feels the vaccine aggravated an old back injury. States it wasn't like when he threw his back out because that pain was immediate. States this was a gradual pain that got the point he couldn't work with it. Patient believes the vaccine caused 2 weeks of back ache. The patient underwent lab tests and procedures which included blood glucose: 144 on 29Apr2021. The action taken in response to the event for BNT162B2 was not applicable. Outcome of event His back was totally wrenched. He feels the vaccine aggravated an old back injury, His blood sugar yesterday was 144 was unknown, His arm was sore for one or two days was recovered and for Back ache/Couple or three days after the vaccine he had pain. It was a gradual pain that got worse/He has to pick up his left leg; if he lifts it on his own it hurts his left lower back, His back was totally wrenched. He feels the vaccine aggravated an old back injury it was recovering. No Follow-up attempts are needed. No further information is expected.
ALTE - acute onset of limp/apnea 24 hours after vaccines, 10 hours after eating. Hosp w/u, incl. blood, urine, chest nl. EEG nl without movement artifact. H/O benign sleep movement d/o 6/13, with (-) o/a EEG.
asymptomatic COVID-19 infection Narrative:  Patient completed 2 dose COVID Vaccination Series with Pfizer with first dose on 1/20/21 and second dose on 2/9/21. On 3/26/21 the patient presented to the ED after a mechanical fall resulting in hip fracture. COVID-19 testing is mandatory prior to admission to hospital. Patient was tested per protocol and resulted as positive. Patient completely asymptomatic from COVID-19 standpoint and no treatment for disease was indicated. Positive result was incidentally found and did not add to or prolong hospital stay.
He began feeling fatigued, tired and kind of lethargic. He then developed a runny nose, cough and other respiratory symptoms like dry mouth. He received over the counter MUCINEX which helped which did help with his symptoms. I gave him rapid COVID-19 home test on December 26, 2022. He remained isolated for a full 14 days. He has since fully recovered from his symptoms.
Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder (past medical history not provided) and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ATORVASTATIN and MELATONIN for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues). At the time of the report, VACCINATION SITE URTICARIA (Hives that itch on her arm, they started on the shoulder and spread to the arm and still continues) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender'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. Further information has been requested.
Patient had almost completed observation period when she ambulated to the observer and stated she felt dizzy. She was observed by clinical staff to also be cool and clammy. Staff immediately placed patient in a supine position with legs elevated. Patient stated she had only eaten a few blueberries at breakfast and had been very nervous about getting the shot. Patient was provided with gatorade and snacks and rested a few more minutes under the watch of clinical staff onsite.  After about 15 minutes, patient stated she felt better and was released from the vaccination clinic to return to class.
Patient states she recieved Zostavax 12/10/08 and developed Zoster 12/13/08. Location of Zoster was on scalp
Breathing difficulty within 2 hours required increased inhaler usage. More tightness overnight requiring dr visit. Nebulizer Rx/ chest X-ray/ antibiotics/ new inhaler
Patient reported during her 15 minute observation to the medic that she is feeling dizzy and her heart is racing.  Patient was taken to the medic location.  VS= 192/116, HR 152, O2 sat=99%
Progressive weakness poor appetite and falling   HISTORY OF PRESENT ILLNESS:Patient is a 77 y.o. female with past medical history of peripheral artery disease, oxygen dependent COPD, hypertension and depression, who presents to the Emergency Department with chief complaint of as mentioned above.   The patient reportedly has been progressively ill for about a week.  Reportedly her husband brought her in by private vehicle to the ambulance bay tonight due to her declining condition.  Husband has left by the time I interviewed the patient.  Reportedly patient was reluctant to come to the emergency department.  Her emergency evaluation showed marked abnormalities including signs of sepsis with a high fever, marked leukocytosis and lactic acidosis.  In addition she tested positive for Covid and was noted to be anemic and in acute renal failure with heme positive stools.  Intent was to transfer the patient to a higher level of care for critical care services, however all area hospitals have no bed availability so the patient is being admitted in the ICU here.   The patient states she does not feel well.  She has mild shortness of breath.  She has had very poor appetite and has been weak.  She said she is fallen several times this week.  She has had some mild abdominal pain and also describes some mild dysuria.  She is unaware that she has had a fever.  She said she has been drinking water.  She said she has had some diarrhea but denies seeing any blood in her stool and her stool has not been particularly black.
Parent said the child's arm was swollen, red, and hot to the touch.  She said the child also had some behavioral issues.  They took her to the ER on 12/02/2020 and the ER said she had an allergic reaction and cellulitis.
Tachycardia  pulse 130's, palpation, lymph node swelling, brain fog ( difficulties concentration)
fuzzy head. right leg thigh itching, first 1-1/2 hrs.  went to bed at 9:30pm, restless night (woke up 30 plus times night long) after waking up next morning at 7:00am, no desire to eat, no energy and all around weakness, stiff neck, stomach cramps, dizzy-light headed,  went back to bed at 8:30am, could not sleep, got up at 9:30am, felt almost normal again.  Normal again at 10:00
Uncontrollable shivering that turned into shaking, fever, weakness, coughing, difficulty breathing, and  nausea, I did not go to the hospital as I was afraid an ambulance would bankrupt me, as it got worse I changed my mind but was unable to pick up a phone and I was home alone. These symptoms started at 2 AM and continued for a few hours until I passed out. In the morning the shivering and coughing was gone but the fever and weakness remained for the rest of the day up until around 5 PM when I was able to get up and move around.
At around 1:30 AM, I had to get up because I had diarrhea. Immediately following that, a horrible head ache began and uncontrollable shaking/chills with fever and nausea. Muscle aches that were worse than any flu I have ever had. I felt unable to function and had to call off work. I slept on and off the entire day on 12/9/21 and was lethargic. I had pain in my left breast and lymph nodes under the left arm were swollen. I was unable to stand for long periods of time d/t not feeling well. I woke up on 12/10/21 feeling better, but left with residual malaise and slight head ache at the base of the back of my neck and back of my head.
Patient reports severe fatigue/ exhaustion and lack of appetite for one week after first dose. Symptoms resolved on their own. Patient had plasma for COVID on 3/27/2021. Her PCP recommended to hold off on receiving 2nd dose for now.
This spontaneous report as received from a pharmacist refers to a 63 year old patient of unknown gender. On 20-MAR-2013 the patient was vaccinated with ZOSTAVAX (19400 PFU) lot # 0240AE (expiry date 15-MAR-2013), 0.65 ml, subcutaneous. Dose number was not reported. On 20-MAR-2013 the patient was administered an expired dose of ZOSTAVAX. No adverse effects were reported. The patient did not seek for medical attention. Additional information is requested.
Received Heplisav-B That Was Not Stored Properly; Initial Report Received on 11-Mar-2020  This report was received from the supervisor of a health center.  The reporter stated that on 11-Mar-2020 a 52-year-old female patient received HEPLISAV-B (lot # 933621, expiration date 26-Jul-2021) in the right deltoid.  The vaccine was reported to have not been stored properly and reached 48 degrees Fahrenheit for 13.5 hours.  The patient had not reported any adverse reactions at the time of report.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
In May I had and am currently suffering from severe joint pain and fatigue. I have seen 3 different doctors for this and have been prescribed different meds or treatments. I have had numerous blood tests and antibody tests to check for  what this cause is. I have not felt the same since my second Covid vaccine.
I had a little tenderness in the arm for about a day. I tested positive for COVID-19 on 12/05/2022. I had a massive runny nose, congestion, fatigue and cough. I reached out to my doctor but never heard back from her. I stayed home isolated, rested and stayed hydrated. As of today, I do not have any lingering COVID-19 symptoms.
Case previously recorded as MA2009-3691. Initial case report received from a pharmacist, via Novartis Medical Communication on 04 NOV 2009. A patient under 1 year-old was vaccinated with S-OIV FLUVIRIN  (batch no. unknown) i.m. No adverse event was reported. MedCom reference no.: NA09-007554.
Arm swelling - 1 1/2 cm circumferential difference, irritable. Shoulder --> wrist, dorsum of hand slight edema.
c/o pain in lt knee also red & swollen from ? DTP shot on 21UAG; awoke several times through the noc; did not want to walk on leg; limping; restless also last noc; knee looked swollen; crepitus, effusion & minimal tenderness, knee effusion;
tested positive for Covid; tested positive for Covid; fever 101°F; 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.  An 85-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "highly allergic to lactose" (unspecified if ongoing), notes: caller states that she is highly allergic to lactose and would like to know if there is lactose in paxlovid, or if lactose has been used as the source of binder? (she has not yet taken the medication). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset May2022, outcome "unknown", described as "fever 101°F"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: Body temperature: (May2022) 101°F, notes: fever 101°F; SARS-CoV-2 test: (26May2022) positive, notes: Caller is a consumer stating that she has tested positive for COVID this morning.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Information has been received from a physician assistant concerning a 51 year old male with hypertension, first degree atrioventricular heart block and hypercholesterolaemia and a history of positive PPD skin test who on 24-JAN-2007 at 12:40 PM was vaccinated SC in the right upper arm with a dose of Zostavax (lot # 656413/1477F). There was no acute illness at the time of vaccination. It was noted that the vaccine was stored at above recommended temperatures. On 26-JAN-2007 at 06:30 AM, the patient experienced mild to moderate localized inflammation at the injection site and also complained of mild to moderate itching at the affected site. The symptoms resolved on an unspecified date without the need for medical intervention. Additional information is not expected.
3 weeks later he contracted COVID; it has been 90 days since his 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (3 weeks later he contracted COVID) and PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose). On an unknown date, the patient experienced COVID-19 (3 weeks later he contracted COVID). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) had resolved. At the time of the report, COVID-19 (3 weeks later he contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (3 weeks later he contracted COVID) and PRODUCT DOSE OMISSION ISSUE (it has been 90 days since his 1st dose) to be not applicable.    Concomitant information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received. The reporter reported that the patient did not receive vaccination at their covid clinic.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Lot number: gn-9693) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: FR8783), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: 301308-A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "depression/anxiety" (unspecified if ongoing); "2 colon cancer (2021)", start date: 2021 (unspecified if ongoing); "Known allergies: Z-pack antibiotics" (unspecified if ongoing), notes: Known allergies: Z-pack antibiotics; "Known allergies: ginger" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine"; Iodine, reaction(s): "Known allergies: iodine"; Betadine, reaction(s): "known allergies: betadine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment on 18Aug2023 to 23Aug2023.
This spontaneous report was received from a nurse and refers to a 3 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The patients received improperly stored (in refrigerator) PROQUAD lot # N010115, expiration date 24-SEP-2018, therapy type: rHA (dose and route of administration were not reported). One was administered on 11-SEP-2017 and two were administered on unspecified dates. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion from 15 to 46 degrees Fahrenheit for unknown length of time. Data logger was involved. There were no previous excursions reported.
itchiness at injection site; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 86 years old female patient who experienced itchiness at injection site (vaccination site pruritus), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the right deltoid.  On an unknown date, the patient developed a non-serious itchiness at injection site (vaccination site pruritus) (since last week) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Final diagnosis was itchiness at injection site.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from itchiness at injection site.  Information on batch number is requested.
Red raised rash all over body with fever. Serum sickness reaction. No urine output >12 hours.  10/19/09 ED records received service date 9/15/09. Assessment: Hives, urticaria. Patient presents with hives in various parts of the body.  ICD-9: 708.9 Urticaria NOS, 305.1 Tobacco use disorder.   12/30/09 DC summary and H&P received for DOS 09/18/09-09/19/09. DX: Serum sickness.  Pt presented with h/o fever, rash arthralgias, hives for 14 days. Tx in ER and PCP office: Benadryl, Prelone, Atarax. Hives resolved and returned again. Pt seen by allergist who diagnosed Pt with serum sickness. Pt experienced increased discomfort, fever, vomiting, puffy face, painful hands and feet.  Treatment continued with Benadryl, Votrin and hydrocortisone cream. Hives migratory and pruritic in LE, abdomen, chest and back. Pt discharged home in stable condition.