chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 6 months old patient (gender unknown) who was given pentacel dilutent part but not the acthib portion, while received vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. On 10-Jul-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date and site of administration not reported in the left thigh. It was reported that patient was given Pentacel dilutent part but not the ActHib portion. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive  and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender- none.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 17-JUN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Left eye infection on 3/19/21,3 internal styes (lower lid); swelling, infection, pain, itching. 3/22/21 trip to urgent care-prescribed Ofloxacin sterile eye drops, both eyes 3x day.3/26/21-2 additional styes developed internal upper lid left eye. 3/27/21 trip to urgent care-prescribed 300 mg Clindamycin 3 x day for 10 days. 3/29/21 follow up with Optometrist. No further prescriptions. Infections mostly clear 4/2/21. 4/15/21-6th stye developed inside lower lid a week after 2nd dose. Treating at home with warm compresses and eye drops.
PATIENTS ARM IS STILL SORE FROM VACCINATION AS OF 1-22-2017.
patient reported redness, itching,  and swelling of her arm at her covid injection site.
42 days post immunization, pt still experiencing  sore shoulder with a swollen "bump" at injections site
Large red, sore,  itchy, hot, rash.  Size of a hand around injection site.  Fatigue. Welt like bumps.
Pt waiting shot time; became dizzy and felt like she needed to lie down; no hives noted; no shob noted; hypotensive in the SBP 89/65;; pt was assisted to room and laid down flat; retook SBP 98/68 HR 67; pt reports feeling better; BS checked 98; pt was given Orange juice; awaiting d/c ; will monitor for symotoms
12/23/20  @2320---left arm pain started with progression to antecubital and axilla and back of neck. 12/24/20 @ 0600 vomited x 2.  Headache, runny nose, fatigue,  general achiness---became worse as the day progress to include both hips and knees  becoming painful.  Shortness of breath with pulse ox levels of 91-97% on room air. Heart rate 104-124 bpm for 9 hours, Chest discomfort, cough, achy fingers, mild hand tremors, flushed face, nausea, decreased appetite, fatigue, chills . 12/25/20 @ 0120--severe muscle and joint pain---self medicated with 1000mg acetaminophen, stomach pain---used digestzen. tossed and turned until after 0428. 0920--increased area of painful lymph nodes: left arm axilla, breast and back of neck. Fatigue continues---although less than the day before 12/26/20 through 12/28/20 symptoms continue to decrease. 12/29/20----woke up feeling great. Took the stairs at work---no shortness of breath. At work received the mail out Covid test-----results were positive ( no symptoms of covid)
Patient reported he developed a rash on his left forearm (all around the forearm) from wrist to elbow approximately 10 days after his first COVID-19 shot.  He said it was extremely itchy and he applied calamine lotion to it to calm the itching.
Initial report received on 07 Oct 2005 from a patient. A 61 year old female patient with a medical history of atrial fibrillation, sino-ventricular tachycardia, osteoporosis, vertigo, ankylosing spondylitis, fibromyalgia and asthma developed chills, facial flushing, hot feeling on face, indigestion and heartburn 4 hours following the influenza vaccine (FLUZONE SV '2005-'2006), lot no: U1846AA, administration in the left arm on 06 Oct 2005. She had also experienced pounding headache, neck pain and generalized aches 8 hours following the above vaccination, among them only aches were persisting at the time of the report. It was reported that, she is taking yearly vaccination with Fluzone and was concomitantly taking treatment of Tiazac, proventil, propafenone, avista, prevacid, Claritin and xanax since an unspecified time. The patient was not recovered at the time of the report. Follow up information received on 23/Jan/2006 from a health care provider. The provider has no knowledge of the incident. Additional information is not expected.
Pt notes onset of dizziness, orthostatic changes, memory loss and lethargy since beginning Anthrax series. This pt Anthrax #1 in 1/99 and shot #5 in 1/00. Since starting the series, she records decreased memory, itching and the appearance of sores in her ear canals, rash and dry skin at the shot site plus thighs, lethargy, vertigo, chest pain, joint pain, diarrhea and sudden clearing of her vision so that she no longer needs glasses. The chest pain occurs 1-2 X per week, lasting 5-10 seconds; sharp diaphragmatic pain and the intensity is incapacitating. She has continuous joint pain involving knees, elbows, ankles and hips often with numbness and weakness of forearm muscles. Sudden movements causes perception of the world spinning around; dx'd in 3/98 with benign positional vertigo treated with meclizine and pseudoephedrine with poor response. The impression is that most physiologic complaints are probably referable to pre-existing Hypothyroidism. There is the possibility that IZ stimulated an inflammatory response which increased pre-existing symptoms or activity of pre-existing disease. Continue IZ's as indicated is recommended. IZ's may cause flu-like symptoms, which may entail worsening of other pre-existing complaints. The follow-up received on 06/10/2001 states that the pt still has he itching at site of injection, dizziness, heart flutters, occasional loss of consciousness, memory loss, and vision correction.
Adjacent gland in "my" neck has remained tender and a bit swollen; throat soreness is on the same side of "my" body as myshot, and the throat tenderness feels more like a strained muscle when "I" swallow.; sharp discomfort in "my" throat; "I" developed a Sore left tonsil during the night that persisted through the day; This is a spontaneous report from a contactable consumer, the patient. A 60-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 01Mar2021 at 12:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory arthritis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included SYNTHROID, BUPROPION, FOSAMAX, and REMICADE, all for an unspecified indication from an unknown dates and unknown if ongoing. All was well until a week after the shot and then on 08Mar2021 at 03:00, the patient developed a sore left tonsil during the night that persisted through the day, salt water gargling helped the patient with the more sharp discomfort in her throat, but the adjacent gland in her neck had remained tender and a bit swollen. The tender gland or throat soreness was on the same side of her body as her shot and the throat tenderness felt more like a strained muscle when she swallowed. The tenderness continued till the fourth day after the event occurred even on the day of report. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event adjacent gland in neck has remained tender and a bit swollen, throat soreness or tenderness, discomfort in throat and sore left tonsil was not recovered at the time of this report.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
15mins post vaccinattion, pt reported throat tightness. Vitals: @17:05 BP 104/66, HR 68, RR 18, O2 Sat 95% -- > @17:15 111/61, 76, 18, 99%  -- >@17:22 91/76, 74, 20, 97% -- > @17:24 108/68, 77, 100% 17:07 - Pt reassessment no SOB/wheezing (audiable).  Continue to monitor. VSS No temp, resp even and unlabored. 17:19 - pT STATED HER THROAT FELT BETTER.  Lungs clear to Aus. regular pulse 1725 PA cleared pt d/c to home with family. Pt d/c in stable condition
Narrative: Patient received Moderna vaccine dose #1 on 01/24/2021 and dose #2 on 02/24/2021 and 3rd dose on 11/30/2021. He presented to the ED on 12/8/2021 with chief complaint of weakness. O2 saturation as low as 91-92% and he was admitted to the hospital and started on remdesevir and dexamethasone.
Mother reports, patient developed a red raised rash on chest and stomach 1 hour after receiving a Hep A immunization. Rash lasted for several hours ad slowly resolved.
3/28/21 Great discomfort in left arm at injection site, limited mobility, unable to lift arm above shoulder for 3 weeks.   Noticed injection site was lower than it should have been.  6/30/21  Difficulty tying shoe and writing.  Progressed through out the next several weeks to months.   Symptoms progressed, weakness in hand and arm.   Significant coordination issues. Unable to drive and work.
11:45am bright red area 4"x4" at and around injection site. 12:00 noon area of redness reduced in size to 2"x2" with 1" welt noted in center. 12:15pm area reduced to 1 1/2"x 1 1/2: with 1/2" welt much less red. 12:25pm MD discharged pt from office to home. No other signs and symptoms noted. No tx given.
Whole arm swollen down to finger malaise/nausea on whole right side of body - headache. Naprosen/Vicoden
Face started swelling to the point that I couldn?t open my eyes. I also developed lesions on my face/scalp. I went to my pcp snd they sent me to the ER. The ER doc said this was a  reaction to the shot. It lasted almost 6 weeks. So much swelling in my head I had a migraine. I finally went to a dermatologist and he injected my head with cortisone and put me on a steroid/ antibiotic to help me. I was MISERABLE.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L035508, expiration date 12-MAY-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
J96.00 ACUTE RESPIRATORY FAILURE 5/12/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
@ 22:00- Resident had BP 223/105, P 103, O2 95% R18, T 100.6, BG 223. Resident is pale, shaking, keeping her mouth open and moving is around without any words coming out, having a hard time speaking and answering questions. Said her head was hurting.
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. On an unknown date the patient received an improperly stored VARIVAX (Merck) (route, dose, frequency and lot # not reported). No adverse effect reported. Additional information has been requested.
pain at base of cranium, blurry vision, beginning August 25 and progressing through August 28, Vision totally normal and other symptoms resolved by August 29
Having like weird side effects kind of my nose got runny; I have been sick; I got too hot; I am right on the bed; Having red eyes; Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night; Throat itch like it hurts; I got too hot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 (Lot number: EW0173) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: I am Asthmatic like some times I can't Breath.; "Allergies to seafood" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that; "Allergies to packaged food" (unspecified if ongoing), notes: I have allergies most like with seafood & I can't eat seafood or packaged food,I am allergic to that. The patient's concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Having like weird side effects kind of my nose got runny"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I have been sick; I got too hot; I am right on the bed"; OCULAR HYPERAEMIA (non-serious) with onset 2021, outcome "unknown", described as "Having red eyes"; EYE PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "Doctor gave me Azelastine eye drops for my eyes, it still bothers me every night"; THROAT IRRITATION (non-serious) with onset 2021, outcome "unknown", described as "Throat itch like it hurts"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "I got too hot". Therapeutic measures were taken as a result of ocular hyperaemia, eye pruritus.  No follow-up attempts are possible. No further information is expected.  Additional Information: Reason for no lot number: of Covid-19 Vaccine: Other: The patient stated, On the paper that they gave me, the person who gave it to me as PS12ER and the bottom of it LOT#EW0173. When probed for vaccine expiration date,patient stated, "There was no expiration date. When probed for patient  weight, patient stated, "patient don't know really. When probed event start date, patient stated, She took the shot and after a couple of days she started having the side effect. Patient  stated, She got too hot.When probed if still having the problem (events),patient  stated, Yes, I just took my cousin (not clarified) told me to take Azelastine eye drops. When probed for event outcome, patient stated, She don't right now and was hot under the same. The patient was  right on the bed,was right now having something like this. Right now I don't know much. The patient was  sick right now." (Event outcome further not clarified. Hence, not captured in the tab).
Patient developed rash on her left arm just below the site of injection, said that it was not too sore, no heat radiating from the site, just a little bit itchy.
One hour after receiving vaccines, patient began vomiting. Vomited several times over the next 9 hours. No fever; no rash. Patient seemed much improved the next day. Patient's sister had a similar illness 5-10-09. Both parents had similar illness later the same week.
Heavy flu like...upset stomach...headache...cold and hot sweats...shivering almost uncontrollably...extreme tiredness.. Lastedv3 days...day 4 feeling 90 percent better
Information has been received from a registered nurse and through a Pregnancy Registry concerning a 17 year old female with no pertinent medical history who on 30-JUL-2007 was vaccinated intramuscularly with the third, 0.5 mL dose of GARDASIL (Lot # "09270"). There was no concomitant medication. It was reported that the patient became pregnant sometime before she received her third dose of the vaccine series. No other symptoms were noted. The patient sought unspecified medical attention. On 01-AUG-2007, the patient had a pregnancy test which was positive with an estimated date of delivery approximately in Jan 2008. No other information was available. Follow-up information was received. The patient had electively terminated her pregnancy on an unspecified date. Upon internal review abortion induced is considered to be an other important medical event. Additional information is not expected.
Patient received the monovalent booster instead of the bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) 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 monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine on 04-Oct-2022. No treatment medications were reported. This case was for 3rd patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:patient 1 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Achilles tendonitis (left), Sought medical care March 1, 2021.  Initial treatment included stretching exercises & rest and but symptoms worsened. Additional follow-up occurred in July 2021. In July, additional treatment included physical therapy and a brace (molded ankle foot arthrosis)
Dizziness Syncopy Numbness Tingly Nausea Possible seizure
Rash and itchiness at injection site.  The rash and itch lasted for 8 days and did grow in size during that period. It started about the size of a quarter and ended up looking bruised in the middle and about 4x the original size.  I am pregnant with a due date of 6/14/2021.
pt recvd vax & had hypotonia episode lasting 4-5 mins; no loss of color or resp; no perm damage noted on clinical exam;
Information has been received from a physician assistant concerning to a 67 year old female patient who had allergy to codeine, lisinopril (manufacturer unknown) and indomethacin. On 10-OCT-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscular in the left arm (dose, lot number and expiration date not reported) for prophylaxis. The same day, in the right arm the patient was vaccinated with a dose of influenza virus vaccine (manufacturer, dose, lot number and expiration date not reported). On 10-OCT-2018, the patient started to experience stiffness of the right shoulder with pain. The patient sought medical attention. No lab diagnostics were performed. No hospitalization, overdose, cancer nor death were reported. At the time of the report the patient was recovering from 1 day joint stiffness and musculoskeletal pain. The relationship between musculoskeletal pain, joint stiffness, PNEUMOVAX 23 and influenza virus vaccine. This is one of two reports from the same patient. Sender's Comments: US-009507513-1810USA008498.
Punctured vial stored in the refrigerator more than 12 hours; Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours) in a 76-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Jul-2022 at 1:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received Moderna Covid-19 vaccine from a vial that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Punctured vial stored in the refrigerator more than 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. On 19-JUL-2022 vial was initially stored in the refrigerator. On 19-JUL-2022 at 10:00 vial was first punctured. Vial did not undergo any temperature excursion. The patient did not reported any other Adverse Reactions or Side Effects. Treatment details was not reported by the reporter.