chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter. No Treatment Information were provided by the Reporter.
A 56 year old male patient received OncoTice weekly instillations.  Within 2 hours after the 5th instillation the patient developed a fever, ranging 37.7-38.3 degrees Celsius.  The 6th instillation has been withheld.  The patient is also experiencing malaise, fatigue, and flu-like symptoms.  Tylenol or Motrin occasionally for the symptoms.
pt ran fever evening of 23AUG93 102.6A @ home; 24AUG93 tc to MD; mom put pt in bed w/her; pt woke up jerking & unresponsive for about 5 mins; 1 hr later had another sz;
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA274335. This case involves a 17 years old female patient and reported that gave the wrong vaccine to the wrong age group, while she received vaccine FLUBLOK QIV which looks like Fluzone Quadrivalent. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 01-Oct-2018, the patient received a once first dose suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1802 and expiry date: 30-May-2019) (dose, dose in series and route was not reported) in the right deltoid which looks like FLUZONE QUADRIVALENT. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. It was unknown if any adverse event occurred. 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 set out in Directive 2001/83/EC 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.
Summary of the event: Vaccine was administered after storage at room temperature for greater than 24 hours.   Summary of details: Date vaccine moved to refrigeration:01Jun2023 Date/Time vaccine was moved to room temp: 08Jun2023 12:25pm Date/time of first vial puncture: 08Jun2023 at 1:44 PM Date of administration: 09Jun2023 at 3:22 PM  Total time at room temperature: 26 hours and 57 minutes Total time since first puncture: 25 hrs 38 minutes Lot: AS7185B Next morning patient was doing well. a bit sore/fussy and some mild bruising/tenderness on the thighs
Started /w whelps on legs approx 3 hrs /p imm. spread to rest of body during the evening & night, difficulty breathing (SOB), facial swelling, low grade T, pruritis, Saw PMD 24 hrs later given Benedryl cream & tabs, felt better 48 hrs later
Patient had fever next morning with short, uncomplicated febrile seizure (first time).  No site reaction.  No therapy
On 10/03/2021, in the afternoon I noticed that I had small rashes around my ankle, and they were red and small dots. Very itchy. Also, at the back of my ears before my hairline. The ones on my head were raised white dots. I just noticed and thought maybe it was just a reaction and it wasn't bothersome. The itchy ones around the ankles seemed to heal after a week. And I still had a little rash on my head. I still had some fatigue like the other vaccines. On November 19, I woke up with my right eye very swollen and red. upper lid was very swollen. Rash was at the bottom and top and middle of the back and it was very itchy and kind of sudden. Same kind of rashes before but they were all developed and really itchy. I called my doctor and she saw me the same day because I was concerned about the rash and eye too. My doctor said it could be some sort of allergic reaction. She gave me an ointment for my eye, that is called Tacrolimus ointment 0.1% twice daily and the eye swelling was gone within 2 days. Fluocinonide 0.05% solution for head and another ointment for the body. I did them twice a day for weeks and it didn't help much. I also bought some Aveno and other products, all natural. Hydrating etc. no perfumes. No improvement, the situation seemed to get better then worsen again and had to contact my doctor again. I had stopped taking all supplements at this point and just took the basic prescriptions that I had to take just in case. She wanted me finally to see a Dermatologist. Early December, the Dermatologist took pictures and did a biopsy of a particular spot because she thought I had Celiac or some reaction. She tested for a couple of other conditions, and she told me to stay away from gluten and stayed away from foods that I could be reacting too. Tried changing diets and changing the clothes I wore and the fabric I was sleeping with. It was just me who had developed this. Received results of biopsy on 12/29/2021 was all negative. 12/30/2021 I was asked to do more blood work. Another test for Celiac was negative. Higher level of white blood cells from blood test. Could be the rash causing that or another condition but it's an immune system reaction. They also put me on Prednisone. The Prednisone doing a tapering course for 3 weeks. I noticed some mild improvement on appearance of the rashes but still having subcutaneous burning and itchiness and I can still feel it in different parts of the body.  I also noticed I have 3 inches below my rib cage on my right side - tissue is very painful to the touch. not on the other side, just a painful to the touch and pushing on it a little. I noticed while I was looking at the rashes.
swelling of the lips and redness if her face; swelling of the lips and redness if her face; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     No medical history information was not provided.  Concurrent medical conditions included Blood pressure. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"). On 04-Mar-2021, the patient experienced LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face). On 05-Mar-2021, LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face) had resolved. On 10-Mar-2021, VACCINATION SITE REACTION ("COVID arm") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure medication.  Patient went to the hospital and got her blood pressure down. At the hospital she received medication to lower her blood pressure, and an antihistamine pill.
Swelling with redness approximately 2-3" in diameter intense itching for 6 days.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 03/09/21 and 4/06/21. Presented to ED 1/30/22 with SOB, Covid+ Admitted 1/31/22 for acute hypoxemic resp failure 2/2 Covid PNA c/b 2/2 bacterial PNA, septic shock w/acute AKI. Resp status cont to decline intubated 1/31. Hospitalization c/b L internal jugular central line infection as well as fungemia, grew candida in the blood w/positive beta-d-glucan as well as +1/2 blood cultures positive for coag negative staph. L internal jugular was removed. Tx'd with vancomycin, micafungin, dexamethasone, remdesivir. Transitioned to comfort care and expired 2/15/2022.
Initial report was received from a consumer on 02 October 2012, who is also the patient. A 25-year-old male patient received post-exposure treatment for a bat bite with one injection of RABAVERT (Novartis) on 05 June 2011. The patient also received three injections of IMOVAX Rabies (Route, Site, and Lot Numbers not reported) on 08 June 2011, 12 June 2011, and 19 June 2011. Ten months later, in April 2012, the patient experienced twitching in the hand and thumb, muscle spasms, and atrophy of the thumb. The patient "has been treated" by his primary physician and also saw three neurologists and had many tests done, including EMG. The patient's past medical history and allergies were not provided. The patient's outcome was reported as unknown. Documents held by sender: None.
Patient had the COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had the COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had the COVID). At the time of the report, COVID-19 (Patient had the COVID) outcome was unknown.            Concomitant medications and treatment information were not provided.  Patient was scheduled for booster, but canceled because of COVID. Patient want to reschedule booster.; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
L Deltoid muscle was extremely painful, pain also felt in L side of neck on day of administration.     Approx 36 hours later, L deltoid reddened, somewhat swollen, in an area about 5x8 inches, and extending into armpit.   Some itching, not severe.
Metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 10:00 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included migraine, obesity, asthma and allergy to antibiotic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), naproxen sodium (ALEVE), rizatriptan benzoate (MAXALT) and melatonin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 25Feb2021 at 11:00, the patient experienced metallic taste in mouth. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event metallic taste in mouth was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt received FLUMIST at about 14:25.  No history of egg allergy.  Pt then went to soccer practice.  No Hx of trauma per parent.  At 1930 pt's mom called to say his nose was swollen and he c/o pain below collar bone.  Unable to breath through nose.  No other difficulty breathing, no rash.  Better in AM - after 1 dose oral BENADRYL.
Extreme muscle and joint pain lasting over 7 days,  including but not limited to difficulty walking and standing, extreme fatigue lasting over 5 days, migraine headaches,
large red welt 4x8 cm and  itchy pink papules to arms and legs
sniffling; lymph node under my arm is painful; lymph node under my arm is swollen; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 20-Mar-2021, the patient experienced RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue). At the time of the report, RHINORRHOEA (sniffling), LYMPH NODE PAIN (lymph node under my arm is painful), LYMPHADENOPATHY (lymph node under my arm is swollen) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
a pediatric dose of 0.2 mL from pediatric vile was given to patient instead of appropriate dose of 0.3 mL from adult vile.
Patient was vaccinated with Pfizer #1 on 3/17/2021 (lot EN6206). He received a second invitation for vaccine in error, signed up, and was vaccinated a second time with Pfizer #2 on 3/28/2021.  No adverse outcomes or symptoms reported;  counseled by doctor that he does not need additional vaccine. Troubleshooting: It appears a second account was created at screening; this may have been due to a volunteer/screener shortage and other events  particular to this Sunday. The patient did not present his vaccine card for March 17 until after he was vaccinated.
after having first dose of shingrix vax. started feeling aching around 9:00 pm same night. Woke up with aches and was shivering and couldn't reach for phone or think straight. Got out of bed at 3-5am, took temp, and it was at 104 degrees. Got into a cool shower, took tylenol and went back to bed. Got up and felt exhausted, rested and by that evening, was feeling better on 08.29.20.
pt recv vax; onset began almost immed p/ vax; feel n, weak, chills, chest tightness, body aches, too weak to get out of bed;
1wk p/vax itching of legs;rash present blotchy @ first-flat & spread over entire legs & arms;no rash on body;
Patient has, red, painful, hard bump at site of injection. It is warm to the touch. We informed patient to go to her MD to be seen as it looks like an infection.
this morning she presented pain on her right breast; she presented severe pain in the injection site, it hurts from her elbow to shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2021, outcome "unknown", described as "she presented severe pain in the injection site, it hurts from her elbow to shoulder"; BREAST PAIN (non-serious) with onset 29Apr2021, outcome "unknown", described as "this morning she presented pain on her right breast".  Additional information: the patient stated that after receiving the first dose of the Pfizer Covid-19 vaccine yesterday she presented severe pain in the injection site, it hurts from her elbow to shoulder and this morning she presented pain on her right breast. She would like to know if the pain is normal.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 month old infant presented to office on 12/29/21 for well-visit.  MD ordered Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), and DTaP vaccine less than 7yo IM (INFANRIX) to be given during visit. CMA prepared and administered the following immunizations:  Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) IM to patient's left thigh (LOT # EM2364) ,HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) IM to patient's right thigh (LOT # U013278), and DTaP vaccine less than 7yo IM (INFANRIX) IM to patient's left thigh (LOT # 7EC55). No issues documented.  Patient returned on 4/12/22 for 18month well-visit.  At this visit, parent endorsed patient had15 month old infant presented to office on 12/29/21 for well-visit.  MD ordered Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), and DTaP vaccine less than 7yo IM (INFANRIX) to be given during visit. CMA prepared and administered the following immunizations:  Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13) IM to patient's left thigh (LOT # EM2364) ,HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB) IM to patient's right thigh (LOT # U013278), and DTaP vaccine less than 7yo IM (INFANRIX) IM to patient's left thigh (LOT # 7EC55). No issues documented.  Patient returned on 4/12/22 for 18month well-visit.  At this visit, parent endorsed patient had "knot" on leg where last received vaccines.  Knot recently went away with only massaging area.  MD noted "slight hyperpigmented skin discoloration on outer left leg".  Patient was administered Hepatitis A vaccine on 4/12/22 IM via patient's right thigh with no issues noted.  System lists local injections site reaction including "Pain at injection site (41% to 57%), erythema at injection site (?32%), swelling at injection site (?22%), tenderness at injection site (children: ?20%)".
No adverse event; HCP mentioned that they accidentally administered a patient with the expired vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.).    No concomitant medication were reported. No treatment information was provided by the reporter.
Case number PHEH2015US021636, is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a 28 year old male patient. Medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with FLUVIRIN (batch number: 157601) whose pre filled syringe was out of temperature range (64 degree Fahrenheit) for 1 to 3 hours. No adverse event was reported following this medication error.
one month after second dose, left ear had ear ringing or as tinnitus and dizziness, those symptoms do not go away. Just started seeing doctor.
left supraclavicular lymphadenopathy; This is a spontaneous report from a contactable other health professional (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FK5730), via an unspecified route of administration (left arm) on 06Jan2021 03:30 at single dose for Covid-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left supraclavicular lymphadenopathy over a centimeter in diameter noticed it 10 days after injection on 16Jan2021 (16:00). There was no treatment received for the adverse event. The outcome of event was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
This spontaneous report received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The medical assistant reported that the patient received three improperly stored vaccines: VARIVAX (unspecified lot and expiry date), RECOMBIVAX HB (unspecified lot and expiry date) and M-M-R II (lot: M027637 expiry: 02-JUN-2018) on 12-DEC-2016. No adverse effects reported. The VARIVAX (lot: M005972, expiry: 02-FEB-2018, lot: M034583, expiry: 27-JUL-2018, lot: M028552  expiry: 07-JUL-2018) was stored at 0C for 6.5 hours. There was no previous temperature excursion. The vaccines RECOMBIVAX HB (lot: M026309, 11-NOV-2018, lot: M039642 expiry: 03-JUL-2019) and M-M-R II (lot: M027637 expiry: 02-JUN-2018) were stored at 18C for 6.5 hours. Additional information has been requested.