chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via a company representative refers to a 66 year old female patient. The patient's medical history included mild hypertension. Four years ago (estimated as December 2009) the patient was vaccinated with ZOSTAVX, administered via injection. In the first week of December 2013 (reported by the physician as last week), the patient presented at the physician office with shingles on the right side of the neck and chest wall. The onset date of shingles on the right side of the neck and chest wall was reported as four years ago (estimated as December 2009). It was also noted that the patient had been in general good health. As treatment for the adverse event, the patient received unspecified antiviral and pain medication. The action taken with ZOSTAVAX was not applicable. ZOSTAVAX was not reintroduced. The outcome of the adverse event was unknown and the causality assessment was not provided. Additional information is not expected.
This spontaneous report was receive from a pharmacist and refers to a female patient on unknown age. The patient's medical history. drug reactions or allergies and concurrent conditions were not reported. On 20-FEB-2015, the patient was vaccinated with a dose of GARDASIL, then, on 15-JUL-2015, the patient was vaccinated for her second dose of GARDASIL 9; (dose, route, anatomical location, lot number and expiration date for the above vaccines were not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Tinnitus - started ~4 days post vaccine administration.  Still occurring 8 days later but lessening in severity of symptom
The injection site is swollen and red after feeling fine for four days after my initial vaccine symptoms subsided. This has lasted for 22 hours already, and the diameter of the swollen and red area is about two inches across with the injection site in the middle of the red circle. The swollen area is tender and painful to touch, and it feels as though there is an elongated flat-ish hard lump under the skin where the injection went in. It does not itch. I regularly take claritin for my allergies, which I continued to take as I read that may help with this.
27 patients received expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (27 patients received expired doses) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.
Fall 2/4 hospital admission 2/7/21 with death on 2/8/2021.  Patient continued to decline on Bipap he was a DNR/DNI and family decided on comfort measures and he expired 2/8/2021.
Headache no relief with Motrin lasted a continuous 13 days with varying intensity. Fever (101) trtmnt- Motrin. Followed by swelling at vaccine site - iced unable to move arm for 2 days.  Telephoned VAERS told to see urgent care - 06/22/2011 seen for reaction and told adverse preservative reaction should resolve itself. 06/28/2011 seen by primary MD blood work as headache still an issue - results show inflammation will redo bloodwork in 4 weeks.
approx 4min p/vax coughing & tightness in chest began;pale became flushed, felt hot;went to MD directly waited until 3:00 to see MD;
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 29th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461: case
AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine
light headed, arm tingling, difficulty moving lips and hands.  hyperventilation.  evaluated by EMS, recovered and sent home
Very swollen and sore lymph node in left underarm; started two days after injection and had continued for three days (so far). Also experienced fatigue and headache the day after the injection, lasting one day.
Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.  Action taken with the product in response to the event was not applicable.
W/in 10 minutes of administering Tdap she became tachycardic, pale, red blotches & difficulty speaking & breathing.
2 days after I received the vaccine, I broke out with a rash. This rash spread to other parts of my body. I went to my GP. She diagnosed chicken pox. It lasted 2 1/2 weeks.
Fever; Headache; Tiredness; Swollen lymph nodes under left arm, left side of neck and base of head on left side; This is a spontaneous report from a contactable consumer, the patient. A 51-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 01Apr2021 at 10:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia syndrome. The patient did not receive any concomitant medications. The patient was allergic to nonsteroidal anti-inflammatory drugs (NSAIDs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 22:00, the patient experienced fever, headache, tiredness swollen lymph nodes under left arm, left side of neck and base of head on left side for extended time (7 days). The clinical outcome of fever, headache, tiredness, swollen lymph nodes was unknown at the time of this report.  No follow up attempts are needed; Information about lot/batch number cannot be obtained.
Arm very warm, sore and extremely sensitive to touch for 3 to 4 days after receiving vaccine, then after 3 days the arm began to itch
Sinus infection; Laryngitis; This spontaneous case was reported by a nurse and describes the occurrence of LARYNGITIS (Laryngitis) and SINUSITIS (Sinus infection) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H21A, 008B21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterol.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced LARYNGITIS (Laryngitis). On 04-Dec-2021, the patient experienced SINUSITIS (Sinus infection). At the time of the report, LARYNGITIS (Laryngitis) and SINUSITIS (Sinus infection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 02Dec2021, the nurse reported the patient got sick and was diagnosed with laryngitis and placed on "steroids" and an antibiotic. The nurse reported over the weekend, the patient was still sick and went to an Facility and was diagnosed with a sinus Infection. The nurse reported that the patient was not given another antibiotic from facility because the Facility reported they could not give an antibiotic to a patient until 2 weeks out from the Moderna booster dose. The nurse reported the patient takes medications daily to treat diabetes (past medical history) and cholesterol (past medical history)  No Concomitant medications were reported.  Treatment information included steroids and an antibiotic (unspecified).  The nurse reported that the patient was not given another antibiotic from facility because the Facility reported they could not give an antibiotic to a patient until 2 weeks out from the Moderna booster dose.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31May2021 as dose 1, single (Lot number: EL9262), in right arm, on 30Jun2021 as dose 2, single (Lot number: EN6201), in right arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 301358A), in right arm and on 09Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" , notes: other medical history: Depression; "herpes" , notes: other medical history: herpes; "high cholesterol" , notes: other medical history: high cholesterol; "obesity" , notes: other medical history: obesity; "asthma" , notes: other medical history: asthma. Concomitant medication(s) included: BUPROPION; ZETIA; NALTREXONE; VALCLOVIR; VITAMIN C [ASCORBIC ACID]; CRANBERRY; ASPIRIN (E.C.); VITAMIN D [COLECALCIFEROL]; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022 at 09:00, outcome "recovering" and all described as "COVID-19".  The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative, notes: Tested negative for Covid four days after the Paxlovid; (21Jul2022) Positive, notes: then tested positive again for Covid four days after testing negative. I have continued to test positive for the last three days. Therapeutic measures were taken as a result of covid-19. Treatment included Paxlovid. No follow-up attempts are possible. No further information is expected.
2011 - Received Tdap on 9/19, 9/20 hands swollen and had hives on abdomen and left flank/buttocks, on 9/21 feet/hands started itching, on 9/22 swelling in hands less.
RN administered two vaccines in the same deltoid muscle per patient preference. The seasonal flu and the Tdap. He was seated in a tall exam chair. RN left the room within seconds of administering the vaccines to make a copy of his covid vaccination card. As RN went to open the door within seconds of leaving him, he had lost consciousness and fell off the table on to the floor. Pt was easily awoken. His pulse was 72 and his O2 sat was 100 %. He spoke within 30 seconds of falling and said "i should have sat in a lower chair, I can't believe that happened so quickly."  FNP  completed a neuro exam on the patient, WNL. RN checked blood pressure twice, gave him some juice to drink. Pt had an abrasion on his right knee and his left ankle. RN cleansed. he denied need for bandage. he has two quarter size contusions on his forehead. he says he thinks he hit his left knee too. after 20-30 of observation and assessment, sent him home. he has a follow up appointment to recheck his blood pressure on 1/4/2022 with provider.
5 cm in diameter indurated, raised, red area noted at Tdap injection site, tender to touch, skin was firm underneath area.
Paleness & lethargy x 2 lasting for 15 min each episode during evening p/1st TOPV, DTP, & HIB titer; This was administered in another MD office mom gave hx of rxn when reporter inquired.
AFTER ADMINISTRATION OF IPV AND VARICELLA PATIENT STATED THAT SHE HAD TAKEN 2 POSITIVE PREGNANCY TESTS AT HOME THE NIGHT BEFORE.
Related to my flu shot reaction last year they kept me in the clinic for 30 minutes I got itchy during that time, about an hour after the injection I developed a rash, I took two courses of Benadryl throughout the day the rash improved. As well as the itching the following day. I?ve had a pounding headache for three days, now. For 3 days after my injection, my joints hurt excessively bad I developed swollen lymph nodes under my armpit of my left arm. My arm was so sore I couldn?t sleep on it it would wake me up if I rolled on it.  I have been extremely fatigued (Friday and Saturday, so far better today, but remains present).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fNHL" (unspecified if ongoing). Concomitant medication(s) included: XARELTO, stop date: 15Jul2022 (Other medication in 2weeks product).  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 treatment from 15Jul2022 to 20Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
productive cough, fever, nasal congestion, runny nose. starting 1/2/22
about 48 hours after immunization patient stated he started having blisters on back, fever, chills and headache. Then he started having light sensitivity in his eyes. Patient was tested for COVID 19 about 72 hours after symptoms started which was negative.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored M-M-R II (therapy type, lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster.  In 2012, he was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Redness, flushing, tachycardia and hives within 5-10 minutes of receiving vaccine.
Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bit of throat scratchiness, took 50mg of Benadryl and two Tylenol pills for my arm soreness and went to bed. When I woke up the next morning it was resolved.
A report has been received from a physician concerning a 4 year old, female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 18-Oct-2013. The patient received first half of vaccine on 18-Oct-2013 but moved their head for second half and vaccine sprayed into her eye and did not go into nostril. The outcome of the event of vaccine sprayed into her eye is unknown. The report was considered to be non-serious.
Awakened from a nap happy. Proceeded to vomit bile twice. Then began having respiratory difficulty with grunting; poor perfusion, pale and mottled. Eyes rolling back then closing and opening and closing to sleep repeatedly. When eyes open not engaged or tracking. Limp, listless, barely responsive for 45 minutes. Resolve spontaneously. Temp max 100.5. Pulse weak. Poor capillary refill.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.          On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.
Diarrhea; Sore lymph node under left side; Very nauseous, no vomiting; Fatigue; Body aches; Fever; Chills; Stiff neck on left side; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck on left side), DIARRHOEA (Diarrhea), LYMPH NODE PAIN (Sore lymph node under left side), PAIN IN EXTREMITY (Sore arm) and NAUSEA (Very nauseous, no vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 30-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck on left side), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 01-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), LYMPH NODE PAIN (Sore lymph node under left side), NAUSEA (Very nauseous, no vomiting), FATIGUE (Fatigue), PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck on left side), DIARRHOEA (Diarrhea), LYMPH NODE PAIN (Sore lymph node under left side), PAIN IN EXTREMITY (Sore arm), NAUSEA (Very nauseous, no vomiting), FATIGUE (Fatigue), HEADACHE (Headache), PAIN (Body aches), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9263), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Vascular issues with stents" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Thyroid issues" (unspecified if ongoing); "seafood" (unspecified if ongoing). Concomitant medication(s) included: TOPROL; SYNTHROID; LISINOPRIL; BABY ASPIRIN; Z-PAK. Past drug history included: Known allergies: mycins, reaction(s): "Drug allergy". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Patient not been received any other vaccine in four weeks.
I had a localized skin reaction for 2-3 days after receiving vaccine ( redness, itching, swelling at and around injection site), which went away after a few days. Today (9 days after vaccine) my skin reaction has returned and is more prevalent than it was the first time. It is very red, swollen, itchy, and hot to the touch.
Lip tingling, swelling and redness. No respiratory distress. No further signs of mucosal swelling. Benadryl 50 mg po given x1. Lips remained same to slightly improved. Normal vitals. No epinephrine given. Discharged after 50 minutes.
On 9/6/00, the pt broke out in red papular rash on face. No fever or other symptoms.