chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received the Moderna monovalent instead of bivalent as his 1st booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose).    No concomitant medications were reported. No treatment details were reported.
Redness swelling and warm to the touch. ER - gave rx of prednisone. - Agency - No rx given.
Right sided shoulder blade pain 9/10 and breast pain min severity; onset 4/23/07. On 4/24/07, rash noted posterior at shoulder blade (fist-sized area) and approx 2 lesions on (R) breast. All lesions itchy.
Large (about 1.75" by 2") red area of redness and mild induration right thigh at the site of DTaP vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 15-SEP-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a hospital for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Was taken to the ER. She felt like she was having a heart attack. Her heart wouldn't stop pounding and she had a sensation from her fingertips up to her chest.
Patient checking out at front desk and fell backwards. Hit head on floor. Cool compresses applied to back of head, given juice, vital signs (BP 139/83 HR 97) and assessed patient mental status.
The practice was out of Daptacel and the MA got confused and instead administered Adacel /No AE; Initial information was received on 24-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional. (Inquiry number: 00533623).  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA).(Suspension For Injection) was administered to a 3 years old female patient, instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 11-Mar-2021 via intramuscular route for prophylactic vaccination (wrong product administered).  It was a case of actual medication error due to wrong vaccine administered.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received second dose early.  First dose administered on 8/23/22  and second dose administered on 9/13/22.  Patient notified of error at time of administration.
LMP  10/18/19.  EDC 7/24/20.  Patient was inadvertently given an expired influenza vaccine.  Manufacturer,  in-house pharmacist and provider notified immediately.  No adverse reactions noted.  Patient received current year influenza.
Patient began having anxiety, nausea, headache, tachycardia, elevated BP.  Patient was walked to nursing staff for further observation.
Vaccine administered 4/1/21 at 3pm.  Body aches beginnings approximately 5 hours post administration. Worsening body aches over   next 24-36 hours post administration.  Tylenol 500mg and ibuprofen 800mg taken at max doses for most of the day 4/2/21 but body aches persisted.  Lessened on 4/3/21 but one dose of tylenol taken at 0900. Body aches gone by end of day 4/3/21.  Mild headache as well starting on 4/2/21 and lingering through 4/4/21.
body aches; delayed reaction of light fever of 99.3 F; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), VACCINATION SITE PAIN (Sore arm) and PYREXIA (delayed reaction of light fever of 99.3 F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 20-May-2021, the patient experienced PAIN (body aches) and PYREXIA (delayed reaction of light fever of 99.3 F). At the time of the report, PAIN (body aches) and PYREXIA (delayed reaction of light fever of 99.3 F) outcome was unknown and VACCINATION SITE PAIN (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 99.3 (High) 99.3 F.         No concomitant details were provided No treatment details were provided   This case was linked to MOD-2021-154924 (Patient Link).
Began having vague chest pain/pressure symptoms in April, come and go.  Around August 16 began having cough, worsening chest pressure .  On August 22 noticed swelling in left calf. Went to the ER and diagnosed with pulmonary emboli in my right lung
Flushing, Heart racing, clammy, sweating, shaky, unable to concentrate
Information regarding FLUMIST (2003-2004 formula) (intranasal) was received from a consumer regarding a female patient who received FLUMIST while nursing. The patient received a dose on 13-Dec-2003. The patient had no medical history. Product was administered on 13-Dec-2003. Dose regimen was 1 dose. Concomitant therapy included MICRONOR. The reporter stated the question "Why did my doctor tell me it was OK to received FLUMIST even though I am nursing?". As of 15-Dec-2003, no adverse events had occurred in the patient or her 5-month-old son whom she was nursing. No additional information was available at the date of this report. Corrected report 30-Nov-2015: Associated case ID added.
Mother of child - noticed on Saturday, 9/13/08 large, red, warm erythematous area on child's right deltoid.  No c/o fever or pain.  Was seen by doctor 9-15-08 - see copy of office note attached.  9-19-08 P.C. w/moc.  Patient is doing fine, area fine now.
PFIZER COVID VACCINE #3 GIVEN 11/15/21, LOT #FH8028; pt brought to ED via EMS with worsening SOB; O2 saturation 60% on RA; placed on CPAP; was able to switch to O2 via NC eventually; found to be positive for COVID; admitted to hospital; given Decadron, Remdesivir, Baricitinib, Vitamin C, Zinc; ABX; bilateral pneumonia secondary to COVID-19; Atrial Fibrillation with RVR; DNR; experienced respiratory failure and passed away in the hospital
This spontaneous report was received from office manager via company representative regarding 21 year old female patient. The patient's medical history and concurrent conditions. She had no concomitant medications. The patient was administered incorrectly with doses of GARDASIL in a series (dose, route and lot numbers not reported) (prophylaxis). The first dose was given on 18-OCT-2012, second dose on 30-MAY-2013 and the third dose on 08-JUL-2013 (Inappropriate schedule of drug administration). The patient did not seek medical attention and no treatment was given. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
COVID-19 Vaccine EUA Swelling,  Redness, Pain, Bruising, Warmth at injection site 6 days after injection date Applied ice to injection site Took OTC Ibuprofen 9 days after injection the site is a little less red & swelling has increased
Swelling in joints of toes and knuckles of right hand. Swelling and pain in ankles and on toe pads of feet. All of these symptoms completely new and never before experienced. These all started within two weeks of my last vaccine and may or may not be related, but it was enough of a coincidence for me to feel compelled to report it. After approximately 3 weeks of discomfort and it becoming clear that it wasn't going away on its own, I saw my doctor on June 3. He ordered blood tests and the one for Rheumatoid Factor came back elevated. He referred me to a specialist (appointment June 9).
I´ve had all my vaccines had shingles/suspected vaccination failure; had shingles 3 times different areas on body breakouts; pain; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I´ve had all my vaccines had shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had shingles 3 times different areas on body breakouts), pain (Verbatim: pain) and rash (Verbatim: rash).The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles three times, three different areas on his/her body, three separate breakouts.  The patient had rash and pain.  The patient said that he/she had them because each and every time he/she visited the doctor. The patient had all his/her shingles vaccines. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. Note: Only one suspect coded as had all vaccine we cannot say how many doses received it could be GSK or NON-GSK or else.
On Monday morning April 19th, 2021, at around 9am I noticed that I was having irregular heart beats accompanied with low heart rates. I went to the urgent care on 04/24/21 and EKG showed bizarre readings. I was immediately referred to the ER.
Information has been received from a nurse practitioner concerning a 23 year old female who was vaccinated (date, route and site were not reported) with GARDASIL vaccine (yeast) (lot # not reported). The patient was HPV negative prior to receiving GARDASIL vaccine (yeast) and after receiving the 3rd dose the patient has tested HPV positive. The patient did not seek medical attention. Per nurse practitioner, the patient has not recovered. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a nurse practitioner concerning a 23 year old female with no known allergies who on 08-FEB-2007 was vaccinated SQ wiht the first dose of GARDASIL vaccine (lot #654885/1424F). On 09-APR-2007 the patient was vaccinated SQ with the second dose of GARDASIL vaccine (lot #656372/0241U). On 06-AUG-2007 the patient was vaccinated SQ with the third dose of GARDASIL vaccine (lot #658282/0929U). The nurse practitioner reported that the patient had normal PAP smears from June, 2001 through October, 2006 and was HPV negative prior to receiving GARDASIL vaccine. On an unknown date in October, 2007 the patient had a positive HPV test. On an unspecified date in November, 2007 it was reported the patient had a negative HPV DNA test. Per nurse practitioner, the event was considered non serious. the nurse practitioner reported that the patient had not recovered from the event. Additional information has been requested.
Mild congestion, Positional headache, and mild nausea began 3am 12/20. Headache continued throughout day, spiking when I stood up (pain scale 7 or 8), and declining or going away completely when i laid down (pain scale 0-3) . By morning of 12/21 only mild headache remained (pain 1-2). Congestion decreased but not gone and mild headache coming and going since, but not dependent on movement. Covid rapid test on 12/22 negative. Mild headache still comes and goes as of 12/24, pain ranging from 1 to 3.
Pt got FLUVIRIN shot on 10/05/2010 and came back on 10/7/10 with swelling, redness and pain at the injection site. She went to a store walk-in clinic where the ARNP told her she had Cellulitis from the vaccine and gave her Rx for KEFLEX. I have already filed report with manufacturer.
Patient received second Pfizer COVID-19 vaccine at 1:55pm. Patient was told to stay in store for 15 minutes. Patient then reported feeling nausous and headed to the bathroom around 2:00pm. Patient reports passing out in the bathroom stall around 2:02pm. Pharmacist was notified by the patient of the incident at 2:04pm. Patient reports hitting his head. EMS was called via pharmacy clerk. Pharmacist took patient's blood pressure (148/62) and pulse (68) at 2:07pm. Patient reports to pharmacist that he had not eaten anything yet for the day and does have a fear of needles as well as history of passing out when getting blood drawn. Pharmacist provided a bottle of water and a plain chocolate bar for the patient to consume while waiting for EMS to arrive. EMS checked over patient since he complained of pain at the base of skull as a result from fall in the bathroom. EMS checked blood pressure (138/74) and blood sugar (78) at 2:18pm. EMS cleared the patient but did education the patient to report any signs or symptoms of concussion. Patient was then escorted home via his girl friend.
Almost Died/I've almost died due to the vaccine; Coma; Severe low blood sugar level; Dizziness; Blood sugar level fluctuations; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness) and BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Since 12 years).    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion). At the time of the report, NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 40 (Low) in morning and 126 (High) later.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.  Patient was diabetic and the day after getting vaccine experienced severe low level of blood sugar level and didn't take insulin per HCP. Patient took 450 gram of sugar and almost died and experienced Coma and dizziness and went to urgent care and no additional medication was administered, insulin level was adjusted and also reports confusion following his incident. patient reports no other condition, medication or allergy and has HCP appointment next month. Patient thinking what happened to him is Moderna Vaccine fault and like escalate his own case and talk to supervisor and like to be contacted by safety team on that day. Medical inquiry process was explained to caller and his case can escalated once HCP calls back and was informed  go to urgent care if he has emergency medical needs.     Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Non significant follow up appended no new information.
hot to touch at injection site; Skin infection; Painful sore arm; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Painful sore arm), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and SKIN INFECTION (Skin infection) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) and Arthritis. Concomitant products included PNEUMOCOCCAL VACCINE from 01-Nov-2021 to an unknown date, VARICELLA ZOSTER VACCINE from 01-Nov-2021 to an unknown date and INFLUENZA VACCINE from 04-Nov-2021 to an unknown date for an unknown indication.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Painful sore arm), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and SKIN INFECTION (Skin infection). At the time of the report, MYALGIA (Painful sore arm), VACCINATION SITE WARMTH (hot to touch at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and SKIN INFECTION (Skin infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) 100.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Had a TIA on  day #11 after her second Moderna vaccine. Never had a TIA before. She was hospitalized for further evaluation. Could be a coincidence but I feel this should be documented and considered for review as a possible risk of the vaccine
After first dose of covid vaccine administration, patient was in the clinical services room while her brother and cousin were receiving their immunizations.  She told her mom that her arm felt a little heavy and then she fell into her arms.  The technician sat her down and called for the pharmacist.  Upon entering the room, I noticed she was a little pale so I got paper towels and soaked them in cold water and applied them to her forehead.  I asked my partner to grab glucose tablets for me.  We gave her two glucose tablets and water.  I asked her mother if she felt like I needed to call emergency services.  Her mother stated that she hadn't eaten in 4.5 hours and has a history of feeling a little dizzy or faint if she over exerts herself if she hasn't eaten.  I sat with the patient for about 15 minutes.  Her mother gave her apple juice and after another 5 minutes she felt fine and wanted to go.
Swelling of the lymph nodes in arm pit and left chest. Pain I the puncture site and swelling. Head ache, fever, sleepiness and body ache.
swollen arm; leg weakness; red arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm) in a 58-year-old female patient 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 HYDROCORTISONE for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm). At the time of the report, PERIPHERAL SWELLING (swollen arm), MUSCULAR WEAKNESS (leg weakness) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Swollen bicep and a large raised red bump at shot location. The red bump was almost 5cm in diameter.  It was also hot to the touch.
Right side face droop  -Hospital stay 2 days . Cleared on own after 4 days
Patient was administered an expired vaccine on 6/21/21.  Vaccine expiration date was 5/15/21
No adverse event reported.  Client presented to facility as first dose by mother.   Client had received 2 prior doses and  was not eligible for 3rd dose.  Mother states she needed the money provided by firs dose incentive from insurance. Client received: Pfizer COVID-19 dose #1 at Doctor's Office on 5-24-2021; lot # EW0186 L Deltoid Pfizer COVID-19 dose #2 at Pharmacy/Store on 6-29-2021; lot # EW0191 R deltoid Pfizer COVID-19 dose #3 at Public Health Facility on 8-30-2021; lot EW0172 R deltoid
Fatigue, headache, mild cramping & shivering. Became nauseous 20 minutes after returning home with episode of syncope. No vomit or incontinence. Pt stated he did not hit his head.
Severe Headache paired with full body ache, tiredness, sore arm at injection site, rash at injection site, nausea and fever of 101.4. Symptoms lasted 2 days. Took Acetaminophen  after 10 hours but it did not help very much. The second day I took 2 Ibuprofen which really helped take the edge off.  Symptoms resolved after 2 days, however Very Itchy Rash at site lasted a full week after injection.
Swelling and redness at injection site. Flu like symptoms (aching, lethargy) for 3 days.
Dizzy, lightheaded. Laid pt on cot and hydrated pt with H20.