chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular menstrual bleeding; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy. The patient previously took codeine and experienced drug allergy. Concomitant medications included ethinylestradiol, etynodiol diacetate (ZOVIA), valaciclovir hydrochloride (VALTREX) and fluoxetine hydrochloride (PROZAC). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 05Mar2021 at 15:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced irregular menstrual bleeding. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event irregular menstrual bleeding was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
choking on food 4 to 5 mins next day 430P; tx CPR
Vaccine was pre-drawn into syringe on 19 October at 1030 tagged and dated with our preprinted labels with expiration of 1630.   Today's first administration of Janssen vaccine was scheduled for 1315 to 1330.  I looked at the date didn't realize that it wasn't today 20 October.  I administered the vaccine to the patient approximately 1400  20 October 2021.
very active stomach, diarrhea due to problem (nervous)/bowel movement really often; very active stomach, diarrhea due to problem (nervous)/bowel movement really often; Stool being dark is concerning; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL8982), intramuscular in right arm on 29Jan2021 at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and had insulin resistance. She had her first dose of BNT162B2 on 03Jan2021. Concomitant medication included metformin. She also mentioned 'Candistan Clotrimazole' (not clear nor clarified) something like that, and also took 'Premarin' (not clear nor clarified) it's hormone for menopause. She got the vaccine instead of 21 days it was 26 days. Since when she had the vaccine, her stomach was really active, diarrhea due to problem (nervous). She informed having bowel movements like really often. Today (Jan2021), she already went twice but the thing was she was going and it was like too dark, mentioned that stool being dark was concerning.  She took Libertrim S11 Trimebutine Simethicone, for diarrhea. The outcome of events was unknown.
This spontaneous report was received from a licensed practical nurse and refers to an adult patient (older than 13 years of age) of unknown gender. There was no information about the patient's pertinent medical history, concurrent conditions, and drug reactions or allergies. The nurse reported that her facility received a shipment of PROQUAD which was mistaken for M-M-R II, and additionally, it was improperly stored on 10-NOV-2016. The temperature was maintained between -9 and 8 Celsius degrees (with a maximum of 6 Celsius degrees) for 143 days. There was no previous temperature excursion. Subsequently on 24-JAN-2017, the adult patient was vaccinated with a dose of PROQUAD lot number: M033612, expiration date: 14-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided) for prophylaxis, which was reconstituted with a properly stored sterile diluent, instead of a dose of M-M-R II. No adverse effect reported. The call was not because of a "data logger". There was no product quality complaint involved. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA014145: US-009507513-1704USA014147: US-009507513-1704USA014146.
Information has been received from a physician concerning a teenaged female who was vaccinated with the first dose of GARDASIL.  The patient experienced dizziness after vaccination.  Subsequently, the patient recovered from dizziness.  The patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Extreme pain experienced on right side just below rib cage. Went to Emergency Room and Pulmonary Embolism in both lung was diagnosed.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's medical history or concurrent conditions were reported. On 09-NOV-2015, the patient was vaccinated with improperly stored dose of MMRII lot # L000459, expiry date 06-JAN-2017, (dose and route of administration were not provided). The vaccine was stored in temperature 46.8 F for 15 hours. No concomitant therapies were reported. No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Dose 2 given 5 days early. Dose 1 was given on 8/7/21. No adverse drug reaction.
Past polio, paralyzed from the waist down. The annual follow-up states that the pt is paralyzed permanently from the waist down.
Moderna Covid-19 Vaccine received on 3/4/21 at 10:45 am. On 3/5/21 at 3:00 am woke from sleep with extreme chills, goosebumps on the skin, and physically shaking to warm up. I had on the bed a sheet, quilt, and heavy comforter. I used the toilet to urinate and was not sure that I could walk back to my bed due to nausea and weakness. After resting, I placed another wool blanket on the bed on top of the comforter. Eventually, I began to warm up. Nausea and fever continued.  Muscles and joints ached. I slept on and off until 7:00 am. I did not eat any breakfast due to continuing nausea. I drank coffee, sat in my reclining chair most of the morning. at 12:00 noon, I ate a bowl of potatte and chicken soup.  My tempereature at this time was 99.5. I did sleep in the afternoon. Later in the evening my temperture had gone down to 99.  Today, 3/06/21 at 8:00am, I feel normal, tired but normal.
ABOUT 24 HOURS AFTER INJECTION BEGAN TO HAVE BACK PAIN AND PAIN AT INJECTION SITE - ELEVATED TEMPERATURE AND SKIN PAINFUL TO TOUCH
The patient c/o dizziness and fatigue upon leaving the vaccination room and was brought back for observation. The patient continued to have dizziness and fatigue with some nausea but no additional issues where observed for the next 2 hours.
MODERNA COVID-19 VACCINE EUA. Temp between 101 & 103.9 all evening with alternating Tylenol & Ibuprofen. Nauseated, shortness of breath are also being experienced.
About a week after my second shot I started to have a consistent haze and low grade dizziness that was about a 3/10 in severity and would increase during certain head movements. My vision was slightly affected. Barometric pressure headaches which I would get a couple a month turned into a couple a week.    Dizziness started about a few days to a week after second shot. Hard to be sure exactly when but after second shot. Had no issues during or after first shot. It?s made driving a little harder and created symptoms I?ve never had like certain motion sickness, heightened dizziness after turning my head left/right or up/down and a feeling of not as sharp concentration.
Vaccine administered at 0855, began to feel dizzy at 0906. Resp even and unlabored. Began having redness and whelps on bilateral forearms and chest. Vital signs stable. Administered Benadryl 50 mg IM. 0920 became nauseated, no vomiting. 0930 redness and whelps noted to be improving. Monitored x 1 hour. Condition improved. Declined evaluation and treatment in emergency department. Instructed to continue to take Benadryl for next 24 hours, and to add Claritin and Pepcid and to seek emergency care if symptoms worsened.
Information has been received from a health professional concerning a 30 year old female who in 1999 was vaccinated with a first and second dose of varicella virus vaccine live. The pt's daughter will be received a dose of varicella virus vaccine live. so the pt requested that titers be done. A varicella IgG titer was negative. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
I got a flu shot I got the flu the same damn day; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who got a flu shot got the flu the same day (influenza), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, the patient got a flu shot got the flu the same day (influenza).  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
had a blood vessel burst in his leg; felt he did not have any strength; pain in arm/shoulder; maybe arthritis which he never felt in shoulder; Could not raise his arm over his head; Pain then travelled to the other arm; It became so bad that he could not use his arm without pain; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder) and PAIN (It became so bad that he could not use his arm without pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 027C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history reported.  Concomitant products included ACYCLOVIR SODIUM, MELOXICAM, TERAZOSIN and ATORVASTATIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (It became so bad that he could not use his arm without pain). On 20-Feb-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), PAIN IN EXTREMITY (pain in arm/shoulder), ARTHRITIS (maybe arthritis which he never felt in shoulder), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm). On 27-Apr-2021, the patient experienced VASCULAR INJURY (had a blood vessel burst in his leg). The patient was treated with NAPROXEN for Adverse event, at a dose of 1 dosage form; ACETAMINOPHEN at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VASCULAR INJURY (had a blood vessel burst in his leg), INJECTION SITE MUSCLE WEAKNESS (felt he did not have any strength), ARTHRITIS (maybe arthritis which he never felt in shoulder), PAIN (It became so bad that he could not use his arm without pain), MOBILITY DECREASED (Could not raise his arm over his head) and ARTHRALGIA (Pain then travelled to the other arm) outcome was unknown and PAIN IN EXTREMITY (pain in arm/shoulder) had not resolved.            This case was linked to MOD-2021-100500 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Significant Follow-up :- patient confirmed regarding events that his arm is still hurting.
Pt. had difficulty putting his thoughts into words. He said his left side of head felt numb.
Six days after receiving her vaccine, she developed a larger than palm-sized raised, red, irregularly bordered area at the injection site. She said it was painful to touch. She was having no other adverse reactions.
Patient stated he felt nauseated and dizzy. When he attempted to stand up to move to the cot, he was unable to steady himself and he said he felt shaky, so RN, brought cot to him, and a few Admin staff surrounded him with drapes dividers. He laid on the cot to rest, legs elevated, and he stayed approx 30minutes. He said he was cold and he just felt "off." Today's dose was his second, and he said he had no reaction to the first dose. He said he ate today. He drank an 8oz bottle of water. Cool pack applied to back of his neck. He said he felt nausous,and was unable to sit up after several minutes of laying down on the cot. After some deep breathing exercises, and resting, he began to feel a little better. RN brought his wife into the area from the car where she was waiting. Eventually, he said he was feeling steady enough to sit in a chair. RN's, B and D helped him out of cot and into a folding chair. After a few minutes, he said he still felt "not like himself" and the decision was made to go to the urgent care. RN D and worker assisted patient to the passenger side of the car. 1500: 124/90 P99  T98.3 R16  1515: 120/70 P67 T98.3 POx99% 1530: 120/78 P80 POx 99% R1
1511 Pt c/o feeling like going to pass out, lightheaded, diaphoretic.  C/O right eye being blurry vision.  OxSat 97%, HR 92, RR 14 easy and un-labored.  States this always happens "when I get a flu shot"  Oriented x 4.  1515 OxSat 97%, HR 94, Blood sugar 110, Firefighter continued to monitor patient. @1524 states feels a litter better.  Right eye is clearing up.  States she is diagnosed with syncope.  States had tilt table test alone.  Continued to monitor pt.  Pt states takes 15 mg Clonazepam for anxiety.  Pt states mom died one month ago of COVID.  @1545 pt states feels better, right eye is no longer blurry. @1557 pt states ready to go home.  States does not need anyone to pick her up and she can drive home.  RN walked with patient to exit door.  RN stated pt had no complaints/issues.
I did not sleep well the night I was vaccinated. The next morning, 1/29/2021, I felt less and less well as the day went on. I was running a fever 24 hours after injection, I napped and the fever was gone by the evening. My left arm, in the armpit area, was sore. I went to my doctor on 2/1/2021. The doctor did an exam and said it was a reactive lymph node. The doctor said to watch it for another week. The soreness in my arm had resolved within the week.
Unknown amount of vaccine leaked out of injection site. Did not immediately revaccinate, will be revaccinating today.
Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), INSULIN LISPRO (HUMALOG) and INSULIN DEGLUDEC (TRESIBA) for an unknown indication.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Blood sugar has been very elevated/Had lots of issues bringing his blood sugar down/Seems like his insulin is no even effective since the vaccine/Increased the dosage of insulin/Cannot control) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Blood glucose: high (High) over 300.     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.  Company comment- Based on the current available information and temporal association between the use of the product and the start date of the 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 the event, a causal relationship cannot be excluded.
aching all over; shivering; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (at age 35).   On 9th January 2023, the patient received the 1st dose of Shingles vaccine. In January 2023, unknown after receiving Shingles vaccine, the patient experienced general body pain and shivering. On an unknown date, the outcome of the general body pain and shivering were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and shivering to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-JAN-2023 Reporter's comment:  This case was reported via interactive digital media. The patient reported that he/she got first dose 2 days ago, sitting here aching all over and shivering at 2:00am as speak.  The patient said but he or she remember chicken pox at age 35.  The patient did not want that hell again. Additional supportive information: Follow up would not possible, as no contact details were available.
I got the 1st dose of the Moderna vaccine on 12/28/2020.   7-8 days later I started feeling itchiness.  Rash was red, warm to the touch, and after a couple of days it spread.  At least 6 co-workers also expressed the similar symptoms 7-8 days later after administration of the shot.   No treatment done except for use of heating pad for one night.  Will set up a doctor's appt.
On 1/20/00, the pt developed a chicken pox rash. Additional information has been requested.
2 month old girl here for PE. As rotavirus vax was being administered, she had a choking spell, turned dusky and limp. Recovered in a couple of minutes with positioning and stimulation. Probably layngospasm episode.
Received flu vaccine in left arm and Pneumonia vaccine in right. Left arm swollen and sore. 8 pm felt quite ill, warm. 11:15 pm Checked Temp 100.9 BP up. Felt tired.
Swollen Left Ankle; Joints hurt; Case reference number MOD-2021-015738 is a clinical trial case report which refers to a 72 Years old Male patient.  The patient experienced Joints hurt which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   .  The patients started Moderna COVID-19 Vaccine on  .  Some  1 day  later, the patient developed Joints hurt.'  Relevant laboratory results included   and relevant physical signs .The patient experienced the following serious criteria:   The eventual diagnosis made was Arthralgia .  The patient was treated for the event . The action taken for Moderna COVID-19 Vaccine. The investigator considered the Joints hurt  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain, swelling, tenderness, warmth, erythema-left arm. Given methylprednisolone 80 mg IM.
developed hives and itching at injection site 1 wk after receiving applied OTC hydrocortisone cream once a day for 2 days. Resolved
Approx. 11-12 hrs. after vaccination, I noticed my leg muscles and back muscles were sore. Within the hour, I had developed a headache. During the night (15-18 hrs. after vaccination), I felt slightly feverish, appr. 100 degrees F.
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL (dose, site and route not reported) on unspecified date. The patient tested positive for a sexually transmitted disease after received the vaccine. At the time of reporting the outcome was unknown. No further information is available.
efrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2020SA032577, 2020SA038302, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038343, 2020SA038344, 2020SA038346, 2020SA038348, 2020SA038350, 2020SA038352, 2020SA038351 and 2020SA038345.  This case involves a four months old female patient who received 0.5 ml dose of IPV (VERO) [IPOL] (lot PIF541M, expiry date 07-Dec-2020) via an unknown route in the left thigh for prophylactic vaccination on 18-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), HIB VACCINE CONJ (TET TOX) (ACT-HIB); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised (product storage error).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder 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.