chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; The vials were in the refrigerator for over 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (The vials were in the refrigerator for over 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-338604 (Patient Link).
Rash in upper torso/neck area.  Not severe or crazy, but noticeable enough w/ raised "bumps".  Rash then spread from neck/shoulder/armpit area to upper chest/stomach area.  Eventually went to upper legs.  Started noticing it around day 5 and it slowly spread.  Not as bothersome during daytime, but at night would itch more and more.  Treated w/ hydrocortisone & calamine lotion.  It has been going on for about a month and i've gone to the doctor 2x, but trying to avoid steroids to keep from diluting immune functions.  Feel the rash
pt stated about 2 hours after getting the 2nd dose of the covid vax that she felt like she was having an allergic reaction since her face started swelling.  Pt contacted her PCP and is waiting on them to CB.  She took two Benadryl and has noticed that some of the swelling has gone down.  For now she will monitor the swelling and wait for the doctor to CB.
Woke up on Friday morning (3/5) with severe neck pain and vertigo. Tried to walk to bathroom and was falling over to the right side and felt very nauseous. Starting throwing up. Arrived at ER around9:30AM and was diagnosed with vertigo and discharged a few hours later. He slept most of the day but woke up for a few minutes to take medicine on Friday evening and told me his vision was blurry. He went back to sleep and slept until Saturday (3/6) morning around 9:30. He told me his vision was still really blurry so we went back to the ER. They did an MRI and MRA and saw that he had two strokes. The strokes have affected his vision and he still has blurry vision and is not able to see well peripherally.
flu-like symptoms, palpitations, chest pain dependent on position, mild shortness of breath that resolved after a few days
Initial headache and malaise the next day after vaccine.  2 weeks from vaccine, the arm where shot was administered had a large red patch with heat, burning, itching and pain. In addition, a headache that lasted for four days with nausea was experienced. 11/23/21 Seen by family doctor for worsening of symptoms. No medical tests were run.  I received a steroid injection at this visit. The doctor explained that I was having a moderate allergic reaction. He also recommended that I start on low-dose aspirin therapy to avoid blood clots.  The symptoms continued for at least another 2-3 days.  12/3/21 I am experiencing headaches X3 days now, which is unusual for me as I do not have any medical conditions.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. on 01-JUL-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ oral liquid (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
From initial information received on 24OCT2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 47 year old male patient received a dose of FLUZONE administered IM in the left deltoid on 22OCT2003 at 4:00pm. The next day, at 6PM , the patient developed a pruritic rash on his trunk , arms and neck. No respiratory or neurologic symptoms were present. The patient was prescribed Benadryl 25mg one to two every six hours as necessary for itching. It is not known whether the patient recovered.
Patient felt her face flush, and felt tingling in her throat, and her ears were hot. Breathing was ok.
(R) thigh (PENTACEL) very swollen, red knee to thigh. Child screaming inconsolably w/ acetaminophen. Advised cool compress and visit to ER due to reaction at child's age.
Patient called and said she can hardly raise her left arm today after getting a flu shot the day before. She said she has many shots before but this one hurts a lot.
This spontaneous report as received from a physician refers to a 15 years old male patient with medical history and drug allergies not reported, who on 18-JUL-2012, was vaccinated with first GARDASIL (lot #, dose and route not provided). On 22-SEP-2012, was vaccinated with second GARDASIL (lot #, dose and route not provided). On 12-DEC-2012, was vaccinated with third GARDASIL (lot #, dose and route not provided). No other co-suspects were reported. No concomitant medications were reported. The physician reported that there not was and adverse effect. No further information is available. Additional information has been requested.
Red spot, itchy, low grade fever, achy,  chills, quezy, tired
Initial report received from a health care professional on 25 May 2010: This patient was vaccinated with MENVEO (batch no 100004), (dose unspecified), on an unspecified date. The reporter stated that the patient was administered vaccine diluent without reconstitution. The outcome of the event was not reported.
Shortly following administration of 1st dose of Pfizer COVID-19 vaccine, pt reports developing redness and swelling to contralateral side of arm in area of biceps. Reports reaction resolved after one week then recurred one week later with no triggering event or additional vaccine given during that time.
Information has been received from a healthcare professional concerning a 72 year old white female who on 04-NOV-2007 was vaccinated on the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 658449/0989U). On 04-NOV-2007, the patient became feverish with indurated rash approximately 8 X 7 cm with pain and cellulitis. The patient was treated with AUGMENTIN. The patient's outcome was not reported. Feverish with indurated rash approximately 8 X 7 cm with pain and cellulitis was considered to be an other important medical event. Additional information has been requested.
moderate symptoms experienced- body aches, fatigue, cough, congestion starting 8/26/21.  Has not seeked medical care.  Still with symptoms 9/1/21
At the noted time for adverse onset, vomiting, fever, diarrhea, extreme headache. Lasted until midnight. The headache lasted through the 25th but not severe; leg aches have continued through the 26th.
This spontaneous report as received from a nurse to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 lot # L043213 with expiry: 28-AUG-2018, lot# M004116 with expiry: 12-OCT-2017 (dosing details and route of administration were not reported). No adverse effects were reported. It was reported that the vaccine was exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced a high fever, my blood sugar was up to 485, soreness and dizziness.
red blotch 2 in X 2 in. around the the injection site; injection site bump; injection site was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was tender), VACCINATION SITE MASS (injection site bump) and VACCINATION SITE ERYTHEMA (red blotch 2 in X 2 in. around the the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was tender) and VACCINATION SITE MASS (injection site bump). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red blotch 2 in X 2 in. around the the injection site). On 16-Jan-2021, VACCINATION SITE PAIN (injection site was tender) and VACCINATION SITE MASS (injection site bump) outcome was unknown. At the time of the report, VACCINATION SITE ERYTHEMA (red blotch 2 in X 2 in. around the the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medication was not provided.
Seizure activity for 4 days starting 1 day after the vaccine. His neurologist increased the Keppra dose. Previously had 2 seizures in the past year. Has not had EEG confirmation that these are seizures. He was doing better today, a week after the vaccine, but will have an EEG if the abnormal movements recur.
9:10 p c/o of dizziness and lightheaded, 122/78, 97, 100% given H2O, rechecked at 9:25p V/S unchanged and dizziness and lightheadedness subsided. remained on site 30 mins. no symptoms, told to follow up with PCP or 911 if symptoms return
Booster at 10 am:  by 9pm I started getting very very cold and arm was aching and tender where injection was.  By 10pm I was in bed shaking, cold; every part of my body hurt terribly.  Around 11pm I took an Advil so I could sleep.  Took an hour to take the edge off my symptoms but only barely.  Slept until 4am & then got up.  Still ached from head to toe; very very cold; took Tylenol throughout day and again it barely took the edge off.  Miserable 24 hours of symptoms.  Started clearing up after 24 hours; still cold, still achy for the next 24 hours.  Then very very tired.  By today, 10/8, I'm feeling almost normal.
GBS distal UE and LE weakness/paralysis developed w/in 3-4 days after immunization
Our doctor and my family believe that Patient has been affected by Covid and the vaccines. She has PACNS )vasculitis) in her brain. We believe this started after she was ill with Covid and worsens after each shot including uvasheld.
Scratchy throat; Shortness of breath; Hoarseness; Dry mouth; Wheezy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 66) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced scratchy throat, shortness of breath, hoarseness, dry mouth, and wheezy. The outcome of the events recovered on 07Feb2021.  Information on the lot/batch number has been requested.
Left index finger has persistent sensation in it that feels like a wooden splinter is lodged within the tip. Also I have been feeling lightheaded and low energy since the dose. No amount of coffee can lift me out of the brain fog I?m feeling.
Breakthrough COVID infection. Ground glass opacities noted on chest CT. Onset of symptoms not clear
Hives across left arm only, started about 24 hours after Hep A #2 given hives no where else on body just L arm.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 5-year-old female patient who received KINRIX (batch number 7574T, expiry date 19th May 2019). On 23rd June 2017, the patient received KINRIX (intramuscular). In June 2017, less than a week after receiving KINRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site itching were unknown. The reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site itching to be probably related to KINRIX. Additional details were reported as follows: This case was reported by licensed practical nurse. After the injection of KINRIX, the patient went swimming in a chlorinated pool. The patient experienced redness and swelling at the injection site. The site was warm to the touch and was also itchy. The patient was scheduled to be seen by the medical staff later on the day of reporting. This case had been linked to the US2017098852, reported by the same reporter.
HISTORY OF PRESENT ILLNESS:  In today for evaluation of a rash.  He was seen yesterday for his routine well care and administration of the flu shot.  Mom reports she noticed the rash between the first and second time she changed his diaper this morning.  He does not seem uncomfortable with itching.  She reports she notes it on his upper legs bilaterally, particularly on the thighs, and she thinks it is more prominent on the left side where he received his flu shot as opposed to the right.  She also notices it on his abdomen and states that it is a red raised bumps.    He is currently towards the end of a course of Augmentin for sinusitis and seems much improved and he had his flu shot yesterday, which mom is concerned that is the cause of the rash.  He is otherwise acting well.  He does not have fever.  As mentioned above, he does not seem uncomfortable with itching or discomfort from the rash.  CURRENT MEDICATIONS:  Augmentin.  ALLERGIES:  No known drug allergies.   PHYSICAL EXAMINATION:  VITAL SIGNS:  Weight was 14.6 kg yesterday.  GENERAL:  He is alert and well appearing.  A limited examination is performed.  SKIN:  He has a scattered slightly raised papular rash that is erythematous and blanches and it is fairly sparsely scattered over the front of his abdomen and down into the pubic area, also noted on his legs, primarily the anterior thighs and it seems a  little more concentrated on the left thigh compared to the right, but not greatly so. These are not typical hives.  They do blanch.  There is no purplish discoloration.  There are no scratch marks, and he does not appear to be uncomfortable.  Dr. also examined the rash.  IMPRESSION:  Rash, most likely consideration Augmentin associated or possible early allergic rash versus a localized reaction from his flu shot, but this seems less likely.   PLAN We will have at this point mom discontinue the Augmentin, since he is so close to the end of his course.  She will watch the progression of the rash and hopefully resolution of the rash over the next 2-3 days.  We did discuss dosing of Benadryl.  He could have 1 teaspoon of liquid Benadryl q.6-8h. p.r.n. for itching should he become uncomfortable, but otherwise I would simply observe the rash. We discussed the use of Augmentin or penicillin-based products in the future, and I think those could be retried with caution and close observation. Mom also asked about whether he should receive the second half of his flu shot in a month and I recommended that, again with observation, since he has no documented egg allergy.  With other concerns, she will call.  Otherwise, second half of flu shot in 1 month.
This infant had an induration on the right leg approximately 6 cm by 5 cm for 3 days, and a fever of 104 for 1 day.
10 hrs after injection arm became completely numb with no use of it for 3 hours then resolved
No adverse effects reported; The patient was inadvertently administered one dose of expired VAQTA; This spontaneous report was received from the office manager regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 05-JUN-2019, the patient was vaccinated inadvertently with expired (expired product administered) Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, one dose, lot number R013515, expiration date 30-MAY-2019 for prophylaxis (route of administration was not reported). No adverse effects were reported.
reports having no appetite starting after her first Primary Series Dose, and this continues to this day; Patient has lost 20 pounds; This spontaneous case was reported by an other health care professional and describes the occurrence of DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) and WEIGHT DECREASED (Patient has lost 20 pounds) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included CROMOGLICATE SODIUM (NASALCROM), LEVOTHYROXINE and ALPRAZOLAM for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) and WEIGHT DECREASED (Patient has lost 20 pounds). At the time of the report, DECREASED APPETITE (reports having no appetite starting after her first Primary Series Dose, and this continues to this day) had not resolved and WEIGHT DECREASED (Patient has lost 20 pounds) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2022-630610, MOD-2022-630614 (Patient Link).
Erythema of immunization area (right thigh) with warmth and mild soreness.
This spontaneous report was received from a certified medical assistance referring to multiple unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown date,  the patients were vaccinated with improperly stored doses of PROQUAD lot # M043306 with expiration date 24-APR-2018 (dosage and route of administration were not reported) for prophylaxis which were reconstituted with properly stored diluent. This vaccines were exposed to temperature excursion from -14°C to -10°C for an unknown time frame because of data logger. The previous temperature excursion was -14°C to -10°C for 21 hours and 15 minutes. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA004663:
Injection site pain; Joint pain; Swollen lymph nodes under left arm; Arm pain; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the left arm on 23Apr2021 at 15:45 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified 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 medication included unspecified birth control pill from an unknown date and unknown if ongoing. The patient previously 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 02Apr2021 at 15:45 as a single dose for COVID-19 immunisation. On 24Apr2021 at 09:00, the patient experienced injection site pain, joint pain, swollen lymph nodes under left arm, arm pain and tiredness. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with ADVIL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, joint pain, swollen lymph nodes under left arm, arm pain and tiredness were recovering 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.
Nausea and vomiting starting @ 9pm 9/16/05. Flu like symptoms. ER visit 9/18/05, RX Clinoril. 9/19/05 saw PMD states reaction to vaccine. Received anti-inflammatory.
localized swelling & redness noted in rt deltoid area & lt jaw swollen x 2 days  1 day p/vax;
Vaccines don't work; Vaccines don't work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccines don't work". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300072190 same reporter/vaccine/event, different patient;
12 hrs. after PENTACEL had fever. Later, during sleep developed muscle fasciculations. Resolve with waking. No seizures. Fevers resolved after 36 hours. Fasciculations continue during sleep.
Product temperature excursion issue; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 44-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.   Reporter did not allow further contact