chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug, Hypertension since 01-Jan-2017, Diabetes mellitus since 01-Jan-2017 and Hyperlipidemia since 01-Jan-2017.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given/ subsequently administered to 2 patients outside of the 12 hour storage window for punctured vials) outcome was unknown. Not Provided      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.   No concomitant medication provided.  No treatment medication provided.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient demographics, medical history updated.; Sender's Comments:  :MOD-2021-111481
Patient received second Moderna 6mo-5yr dose 3 weeks after their first dose. It should have been an interval of 4 weeks. Per CDC guidance, dose must be repeated 28 days after the error dose (8/11/2022). Patient has been notified.
Had to reschedule her second dose appointment because she wasn't feeling well; Had to reschedule her second dose appointment because she wasn't feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well) and PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well). At the time of the report, MALAISE (Had to reschedule her second dose appointment because she wasn't feeling well) and PRODUCT DOSE OMISSION ISSUE (Had to reschedule her second dose appointment because she wasn't feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Expired vaccine. Patient showed/reported no signs or symptoms of distress of allergic/adverse reaction after 15 minutes of observation. Patient discharged.
Patient was exposed to someone with COVID on 7/21/2021, she did not develop symptoms, she tested  positive for COVID on 7/27/2021
Pt complaining of dizziness, diaphoresis about 8 hours, post vax. Complained of chills, 24 hours, post vax with dizziness. Afebrile. Seen by PMD, 24 hours, post vax. Per employee, pain medication given and note written for 2 days off. Employee has weekend scheduled off; no lost time.
My son went to his pediatrician for his 9 month check up on Tuesday 8/5/08.  About 45 minutes before the vaccine was given I gave him 0.8 mL of Infant Tylenol.  About 4 hours after the third (and final) dose of his Hep B vaccine was given (Tuesday 8/5/08) my son came down with a high fever (about 103*), was listless, almost non-responsive, his feet turned blue, he was shaking and had the chills, he had A LOT of difficulty breathing, was weak and had a very fast heartbeat (about 174).  The symptoms came on all of a sudden; he woke from his nap in a good mood, was brought downstairs and in a matter of minutes his state completely changed.  I took him to the pediatric ER at Hospital immediately, he was given Motrin and Gatorade - and I was told he probably had a virus.  I was sent home and advised to keep giving Motrin and Gatorade.  The following day (Wednesday 8/6/08 - after the vaccine and reaction) he still had a fever, was not his usual self, and developed hives on his left thigh around the injection site.  I spoke with my pediatrician the following day (Thursday 8/7/08) and again on Saturday (8/9/08) and it was determined patient probably had a reaction to the vaccine as no one else in the home (including his twin sister) had gotten ill.  As of Saturday 8/9/08 he was well and no longer getting Motrin.  It has been two weeks (8/19/08) since the reaction and no one in the home or close to him has been sick.
Throat scratchy, fatigue, redness around site, 101 degrees F fever, congestion, soreness at vaccine site.
Headache; pain; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. Caller was calling on behalf of the patient who took the first dose vaccine yesterday 17Apr2021 and she was experiencing headache and pain right now (Apr2021). The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Can't taste or smell food; Can't taste or smell food; No desire to eat; Headache; Severe bleeding; No power; He got tested and the blood became too thick; A spontaneous report was received from a consumer concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe bleeding, he got tested and the blood became too thick, headache, no power, no desire to eat, and can't taste or smell food.     The patient's medical history was not provided. Concomitant product use was provided as anti-depressants and anti-anxiety medication but was unspecified.  On 28JAN2021 prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:030L20A) intramuscularly for prophylaxis of COVID-19 infection.    Patient received the 1st shot of the mRNA-1373 vaccine on 28Jan2021. Patient reported hearing that the vaccine could have messed with his coumadin levels. Patient got tested and reported that the blood became too thick and that after treatment to thin the blood, he had severe bleeding. Patient has a rhino rocket in his nose. About two weeks later after the vaccine, patient reported a headache, having no power, couldn't taste or smell food and had no desire to eat. Patient also reported following up with his Primary Care around about taking more anxiety medication due to this situation. The patient's doctor has provided his approval. Patient wanted to know if the side effects he is experiencing two weeks after the vaccine are normal.   Treatment information was not provided.   The outcome of the events was unknown.; Reporter's Comments: There is not enough detail in the absence of patient's medical history, onset date and list of concomitant medications to assess the events of blood became too thick and severe bleeding and can't taste or smell food. The events of headache, no power, no desire to eat are temporarily associated with the vaccine administration and a causal association cannot be excluded.
After 3 minutes of shot I felt very hot and left arm got numb; After 3 minutes of shot I felt very hot and left arm got numb; My chest was like butterflies; Felt dizzy; had to pull mask away from face as hard to breathe; Head hurt; Got leg cramps; still very tired; My eyes are reddish; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200) via an unspecified route, administered in Arm Left on 22Feb2021 at 12:00 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation. Medical history included migraine, irritable bowel syndrome. Concomitant medication included thyroid (ARMOUR THYROID, 60mg) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. On 22Feb2021 at 12:03 it was reported that after 3 minutes of shot she felt very hot and left arm got numb, her chest was like butterflies, felt dizzy, had to pull mask away from face as hard to breathe, head hurt, got leg cramps, still very tired, and her eyes are reddish. It was reported that just before the 15 minute wait was over, dizziness started to subside, got her breath back. And then she left, when driving home, got leg cramps, had to pull over and stretch. It was reported that to this day she was still very tired. Her eyes are reddish. And her legs cramp up when driving more then a half hour. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient did not receive treatment for the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Patient was inadvertently given 0.3 mL of vaccine instead of 0.5 mL. Per our regional Doctor, patient did receive valid dose since dose administered was over half of agency recommended dose. Regional doctor instructed that patient should be notified of incident but told that repeat dose is not necessary at this time.
Starting November 10th around 8 pm  patient developed fever (over 100F), extreme back pain with pain all over the body and dehydration.  She took Tylenol and Ibuprofen.  Fever did not improve . The temperature was 98.99  degree with Tylenol but  again comes back at 100.5 to 100.9 F at night .She went to the ER on 11/13 and got Toradol and  tramadol for home for pain. She also has stomach cramps , diarrhea, and loss of appetite.  She is drinking Gatorade and alternating Tylenol and Ibuprofen. Symptoms still active as of 11/16/23
Pt reports diffuse itchy red non-raised rash across chest, neck, torso, and back approximately 30-40 hrs after vaccination. Did endorse intense itching and redness around ID injection site.  Pt sought medical care and received steroid injection and symptoms have since resolved. Pt denies swelling or other notable signs/symptoms.  This RN advised pt to seek additional medical care if return or new symptoms.
The next morning of the vaccine on 1/9/2021 I started feeling fatigue, headache, chills & muscle ache. This symptoms lasted24hrs they where gone by 1/10/2021 morning.
1/5/21 developed redness, pain and warm to touch on injection site. No itchy, temperature or other symptoms.
Itchy rash on arm that is still persisting through today. I have used Benadryl and hydrocortisone cream to treat it.
multiple deep vein thrombosis of left lower leg, started on Xarelto, hematology referral, swelling improving
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment medications were not provided.   Reporter did not allow further contact
Within an hour of vaccine, almost immediately had a fever (100.4). 2 hours post vaccination, I had a fever of 102 even. 2.5 hours post vaccination full body aches and a fever of 103.2. Slept most of the day. Following day, low-grade fever. I've had shortness of breath and lethargy ever since the vaccination. I am a very healthy 30 year old female, in shape with an appropriate diet. Who has never had these symptoms prior to the vaccination.
Patient developed a bruise shortly after administration, then developed a rash on left upper arm that started around 11/26/17-11/27/17 (2-3 days after administration). The rash is characterized as dry, itchy, bumpy, and red. The rash has spread from the patient's arm to her abdomen. It has not resolved as of 12/3/17.
Injection 1: 01/30/2021 abdominal pain upper right side under rib cage. Lasted about 3 hours 02/01/2021 more accute symptoms of right abdominal pain 2 instances 1 lasting 3-4 hours and one lasting over 6 hours.   Injection 2: 02/25/2021 acute abdominal pain lasting over six hours.  03/01/2021 worst abdominal pain ever, transported to Medical Center Emergency Room.  Diagnosis: inflamed gallbladder 03/04/2021 gallbladder removed
Rash on arm where vaccination was received.4 inch round, red,  warm and itchy. Spreading  since vaccination, but most most rapidly 5 days after vaccination.
Upper lt. arm became infected on 10-10-15. Sent to ER on 10-14. On 10-16 infected to elbow sent to ER.
Swelling on her ja right below her ear; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her ja right below her ear) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Feb-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 SWELLING FACE (Swelling on her ja right below her ear). At the time of the report, SWELLING FACE (Swelling on her ja right below her ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Patient was given his first modern dose.  About 10 minutes after vaccination the patient and his wife alerted me that he was feeling like he was going to pass out.  Also reported feelings of ringing in ears, nausea, cold sweats and very pale.  I had the patient sit on the ground.  I offered him water, but his wife got him a soft drink.  He notified us that he had not eaten today.  We gave his wife glucose tablets which the patient took 2.  He took the 2 glucose tablets while we waited for EMT's to arrive.  He had more color in his face after the soft drink and glucose tablets.  The EMT's evaluated him and decided to take him to hospital out of caution.
103 temp, severe headache, eye pain, tingling in hands childrens ibuprofen administered to reduce temp.
administration of menquadfi post excursion with no adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA082416, 2023SA082675 and 2023SA082363.  This case involves a 16-year-old female patient who had administration of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 11-Jan-2023, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection at a dose of 0.5 ml total (lot U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization.  On 11-Jan-2023 the patient had administration of menquadfi post excursion with no adverse event (poor quality product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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 the 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.
The first one gave me the shingles; This case was reported by a consumer via and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself or herself. The age at vaccination was not reported. The patient reported that the first shingles shot gave him/her the shingles. The patient stated that did not believe everything you hear or see. For tolerance of 2nd dose refer case US2021AMR178120.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178120:same patient/ reporter
constant metallic taste that started approximately 1 hour after receiving the vaccine that has now exceeded 24 hours for duration.
patient had redness and swelling about 3-4 inches in diameter about 3 inches below the injection site. It is warm to the touch.
On 11/2022, I started having rectal bleeding. I mentioned it to my gynecologist and she found nothing. I then scheduled an appointment with a Gastroenterologist.  I went to the urgent care on 01/11/2023. They did Blood work and  X-ray. It didn't show anything. I went to see the Gastroenterologist on 02/09/2023. They didn't find anything wrong.  I was scheduled for Colonoscopy on  03/15/2023, the result was normal .  I went my doctor's office on 04/07/2023.  She is working with the Rheumatologist  with my issue  and prescribe me Humira and sulfasalazine. It's been 1 week and few days but haven't seen any improvements  yet. I 've communicating with  my doctor as well .  I have a follow up appointment  with  my doctor within  3 months. As of now I haven't recovered yet.
awoke during night with pain and redness at injection site.  developed fever to 101.5 and chills later in day. area of redness has continued to spread; now 16 cm in diam and blotchy despite Rx ceftin on 12/15.  today rx prednisone.  note pt had received H1N1 vax opposite arm at same time.
Child complaint of pain on both arms and itching per mom. Rash on vaccination sites only which itched on both arms. Mom reported L arm being hot to the touch. R arm was very slightly warm to the touch. Per mom child had no fever. Temp wasn't taken but mom said she didn't feel warm or hot to the touch. Mom is giving Ibuprofen for the pain.
BAD HEADACHE, NAUSEA, FATIGUE (SAME DAY & NEXT DAY), CHILLS (NEXT DAY)
Mom reports patient vomited and became pale and less responsive than normal. Entire event lasted a few minutes, and he recovered to normal level of consciousness spontaneously.
This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient of other race received PREVNAR 13, via an unspecified route of administration in the right arm, on an unspecified date, at single dose, for immunisation. The patient was vaccinated at physician's office. Medical history included diphtheria (when she was a child). The patient was basically healthy. There were no concomitant medications. On an unspecified date the patient had all the signs of lupus with outcome of unknown, extreme tiredness with outcome of unknown, arms swollen/arm next morning was swollen and red like crazy with outcome of unknown, rash with outcome of recovered, fever with outcome of recovered, couldn't move with outcome of unknown, eyes were watering with outcome of unknown, ears were running with outcome of unknown, diarrhoea with outcome of unknown, appetite was like her whole eating system was just messed up with outcome of unknown, symptoms of arthritis with outcome of unknown, feeling unwell with outcome of unknown, arm next morning was swollen and red like crazy with outcome of unknown, had a fever and chill with outcome of unknown, couldn't lift arms with outcome of unknown, white blood cells highly elevated with outcome of unknown, whole body lock down with outcome of unknown, every joint in the body was stiff with outcome of unknown, her muscles were sore with outcome of unknown, blood pressure high with outcome of unknown, weight loss with outcome of unknown. The patient underwent lab tests and procedures which included blood test on an unspecified date (unknown results). Therapeutic measures were taken as a result of rash.
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Non Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 15-Oct-2015 - 15-Oct-2015, Batch no: U56907 (expiry 30-Jun-2016), Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On Oct-2015, after starting treatment with AFLURIA the patient experienced her arm starting hurting/arm pain . On 15-Oct-2015, after starting treatment with AFLURIA the patient experienced heard a loud airy sound during administration. On an unknown date, after starting treatment with AFLURIA the patient experienced chest sensation described as shortness of breath/shortness of breath, administration of expired vaccine. For relevant test results see appropriate report section. Reporter's assessment: The reporter stated the expiration date is 30-Jun-2015. Case correction (01-Dec-2015); AE 4 (hear a loud airy sound during administration) deleted.
Tested for covid dec 22- negative, no symptoms  Vaccine taken on dec 23 Extremely sick dec 31, tested positive for covid. Sore throat,  muscle aches, cough, fatigue
This spontaneous report was received from a registered nurse via a company representative concerning 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose and route unspecified) and waited less than 12 weeks between second and third dose. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Patient started sweating , loosing consciousness, eyes open but not responding  about 5 minutes after vaccination, this happened twice before paramedics arrived. Paramedic said blood pressure was low and drove patient to ER.
Patient was possibly given the entire vial.  LPN states she measured out 0.3 ml but there was no vaccine left in vial for the next injections.  No adverse events or symptoms noted.  Patient remained in office for 15 minutes following injection.   Called patient at  3:45 pm and spoke with his wife to explain what had happened and she stated he was doing fine and he stated that his arm was "a little sore" at the injection site.