chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received dose of Moderna vaccine beyond 30-day use by date; Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator) in an 88-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date). In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up contains no new information.
ARM STARTED TO SWELL AND GOT RED WITHIN A COUPLE HOURS OF VACCINATION, IT WAS ALSO WARM TO TOUCH. REDNESS SPREAD OVER NEXT 2 DAYS AND PATIENT WENT TO EMERGENCY ROOM ON 10/14 AND WAS GIVEN A CEFAZOLIN INJECTION AND A PRESCRIPTION FOR CEPHALEXIN.
Pain in arm like a tents shot for about a day and a half; headache; dizziness; This is a spontaneous report from a contactable other hcp, the patient. This 19-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK4176) (dose #1), via an unspecified route of administration in the left arm on 04Jan2021 at 19:00 (at the age of 19-years-old) as a single dose for COVID-19 vaccination. Medical history included depression from an unknown date and unknown if ongoing, panic disorder from an unknown date and unknown if ongoing and a weak immune system from an unknown date and unknown if ongoing. The patient did not have any allergies to medications, food, or other products. 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. The patient was not pregnant at the time of vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) and an unspecified antiacid. On an unspecified date in Jan2021, the patient experienced pain in arm like a tents shot about a day and half, some headache and dizziness the first few hour. No pain or symptoms reported after 3 days following the vaccination first dose. No therapeutic measures were taken as a result of the events. The clinical outcome of pain in arm like a tents shot about a day and half, some headache and dizziness was resolved on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Pt's lungs hurt bad, hurt to breath, and then couldn't breath 2 hours post vax. Pt was taken to ER and admitted to hospital. Put tube in throat so she could breath then gave her a shot to reduce swelling. Took tube out 15 minutes after shot was given.
Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Arm started to swell, get red, throb and ache; Patient's arm itches and is spreading down the upper arm; Temperature is 99.2 F at the part on patient's arm that is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache), PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache) and PRURITUS (Patient's arm itches and is spreading down the upper arm). In March 2021, the patient experienced FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm started to swell, get red, throb and ache) outcome was unknown and PAIN IN EXTREMITY (Arm started to swell, get red, throb and ache), ERYTHEMA (Arm started to swell, get red, throb and ache), PAIN (Arm started to swell, get red, throb and ache), PRURITUS (Patient's arm itches and is spreading down the upper arm) and FEELING HOT (Temperature is 99.2 F at the part on patient's arm that is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient tried cold packs as corrective for events. No concomitants were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Events added, outcome and corrective updated.
Patient reported on 1/7/13 that his right deltoid muscle was very sore making it hard to use for 1st week after flu vaccine was given. Deltoid still hurts but is improving - almost normal now per pt.
I started having a sore throat and nasal congestion, runny nose on January 31. The sore throat was upon me waking up and on February 3 I started having a low-grade fever and chills. Prior to that I did a COVID-19 test and I was negative. On February 4, I tested again, and I was positive for COVID-19. The test I did at home was flow flex and then I was given PAXLOVID which did help. On February 11 I tested again, and I was negative.  I feel like my COVID-19 case was very mild.
little pain in his arm and it was warm, gained pain in his legs; little pain in his arm and it was warm; Friday night the caller had a reoccurrence and had a terrible pain in his left knee and radiated in his leg; This is a spontaneous report from a contactable consumer or other non HCP (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing arthritis in his right knee. The patient's concomitant medications were not reported. It was reported that, the patient was calling about the covid 19 vaccine. The patient got his first shot and had no problem. The next day, the patient had a little pain in his arm, and it was warm. Late in the day, the patient gained pain in his legs, his legs aren't good to start with. It was an uncomfortable night and then the patient was back to himself the next day as far as his legs go. The patient asked can side effects occur 8 to 9 days after the shot. Friday night the patient had a reoccurrence and had a terrible pain in his left knee and radiated in his leg. The caller has arthritis in his right knee already. The next day, the pain was gone. Sunday, the patient was cooking, and he had pain in his right knee. The pain was so bad that the caller had to stop cooking and put a heating pad on it. The pain was manageable. The patient wants to know about this because he gets his second shot next week, especially if it was a result of the first shot. The outcome of the events was not recovered.   Information on the lot/batch number has been requested. The patient received the treatment for the knee pain.
Got vaccine and now has a base ball size nodule on her arm where the vaccine was administered. she said the nursing student administered it wrong, it was not in her deltiod, where it should be, was more lower of the arm near the elbow. Reports body aches chills, fatigue, low grade fever.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-047108 (Patient Link).   Reporter did not allow further contact
Patient fainted after receiving vaccination. After a period of 15 minutes, patient was able to leave under her own power.
I woke up with pain in my left upper arm and saw a three inch circular pink/red rash where my shingles shot was given. Also, have had a slight head ache since the shot.
Stored beyond use date.  Moderna analysis revealed possible reduced effectiveness.  A third dose recommended to patient.
Pt presented for 1st dose Moderna Vaccine.   Reviewed and completed required documentation prior to administration.   Around 5 min. post immunization pt exhibited N/V, supervisor informed.  pt vitals were taken, informed provider CRNP.  instructed oral nausea medication. pt refused EMT at that time. Pt given Zofran 4mg PO.  Pt was unable to keep down.  Vitals were taken every 10 min. with elevated bp.  Informed Dr. of situation and urged pt to go to ER.  Pt agreed, EMT was contacted and arrived around 20 min. after.   Prior to EMT arrival pt C/O left jaw tightness.  EMT arrived and transported pt to Hospital
At 2:00am, I woke up with chills, muscle aches, and nausea. The symptoms kept me awake for about an hour. I fell asleep and woke up feeling fine.
The patient received their first vaccine on 1/15/21 via long term care facility and their second dose on 4/15/21 at Pharmacy. The patient then came in for an additional dose on 5/13/21. The patient's caregiver called on 12/24/21 to schedule a booster dose at which time she was told the patient had already received 3 doses and would not need an additional dose. The patient is not reporting any symptoms and is asking for a booster shot, but the 3rd dose (05/13/21) was given early.
incorrect pfizer covid 19 vaccine administered - should have been fpizer covid 19 bivalent vaccine
Erythema, induration 3x4 cm. Complaints of pruritus. No treatment.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00596556) and transmitted to Sanofi on 11-May-2021.  This case involves a two-year-old female patient who received an expired 0.5 mL dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ178AA and expiry date: 04-May-2021) via an intramuscular route in the left thigh for prophylactic vaccination on 11-May-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  The reporter requested guidance on how to proceed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.
pt recv vax & became pregnant EDC 11/9/98;pt gave birth to infant male child devel newborn jaundice which resolved p/2 days of phototherapy & dose not attribute jaundice to vax;
Tdap IZ on Wed. 11/24/10 at 4pm in (L) upper arm. Hot & swollen on Thurs eve. Seen in clinic on Sat 11/27 erythema minimal edema well demarcated 5 cm x 5 cm.
blue bruises on the outsisde of the arm and also underneath all the way down to the wrist; feeling a little bit warm on the upper side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from medical information team.  A 75-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, single (Lot number: GJ5342) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 14Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for atrial fibrillation. Vaccination history included: covid-19 vaccine (Dose 1, single, LOT#EN6200), administration date: 01Mar2021, when the patient was 72-year-old, for COVID-19 immunization; covid-19 vaccine (Dose 2, single, LOT#EN6207), administration date: 22Mar2021, when the patient was 73-year-old, for COVID-19 immunisation. The following information was reported: CONTUSION (non-serious) with onset 21Oct2023, outcome "not recovered", described as "blue bruises on the outsisde of the arm and also underneath all the way down to the wrist"; FEELING HOT (non-serious) with onset 21Oct2023, outcome "not recovered", described as "feeling a little bit warm on the upper side". The events "blue bruises on the outsisde of the arm and also underneath all the way down to the wrist" and "feeling a little bit warm on the upper side" required physician office visit. Therapeutic measures were not taken as a result of contusion, feeling hot.  Additional information: Patient received both the flu shot and the Pfizer Comirnaty 12+ 2023-2024 formulation on 14Oct2023.  A week later she had blue bruises on the outside of the arm and also underneath all the way down to the wrist, feeling a little bit warm on the upper side. The shots were given in the same arm, the left arm on the same day. Her whole arm is now a purplish black color, exactly like the color of an eggplant, from the top of arm/shoulder all the way down to the wrist. The color turned to dark purple and blackish and forearm from the top to the hand is whole black outside, inside of this still getting there. On the inside arm, the lower arm is little white there, but all the rest is purple, exactly eggplant colored. Her primary doctor said they've never seen this and didn't know. They knew all knew she was on warfarin, and they said its okay, and it was okay to take two of them together. She always followed all the guidelines. She has had all the previous Pfizer Covid vaccines before and asked if there something different in the new one. Patient is on warfarin (COUMADIN) but is a retired pharmacist and checks her blood levels (INR) for it everyday and adjusts the dose she takes accordingly.
The site ended up becoming very sore. I started getting severe muscle pain. This was like a flu I?ve never had before. The pain was in my lower back and radiated everywhere. And the highest my fever peaked was at 101.5. I was shivering but my body was also heated. High fever and incredibly uncomfortable with the body pain and body aches.
Cellulitis at injection site which is getting bigger on the day after the injection. Patient is experiencing "flu like symptoms." She went home from work due to her symptoms the day after the injection was given.
This spontaneous report as received from a pharmacist refers to a currently 19 years old, non pregnant, female patient (the pharmacist's daughter). The patient did not have any pertinent medical history and drug reactions or allergies. On an unknown dates, the patient was vaccinated with GARDASIL (dose 1, 2 and 3) (doses, routes of administration, lot numbers and expiration dates were not reported). On an unknown dates, after receiving her first two doses of GARDASIL, the patient experienced pain at the injection site. The pain resolved on an unknown dates, by the next day after each injection of GARDASIL. There was no treatment given for adverse events and no lab diagnostics studies performed. The patient did not experienced pain at the injection site with the third injection of GARDASIL. The relatedness between the events and the vaccination with GARDASIL was unknown. The patient did not seek medical attention. Additional information has been requested.
patient received first dose on 4/2/21 and received the second dose on 4/16/21 too soon
severe ringing in both ears. started 45 mins after injection. also, cold sweat for approx 5 mins after injection. to date ringing still there and very severe.
Patient woke up at 3:00 am on 6/21/12 complaining of (Rt) arm pain, back pain, stomach pain, nausea, chills. Temp at 100.5 F. Reported by father at 1:15 - 6/21/12. Denied swelling, redness or rash at injection site. Advise to see private physician, seen at 3:30 pm at dr's office with redness, swelling at (Rt) arm, shoulder. Lab indicated UTI. Tx with ATB, PHENERGAN. Pt doing better as of 6-22-12 at 10:00 am.
On April 6th, after 30 hours of receiving the first dose of the vaccine. Approximately at 5:00PM , there was a little bit of heart racing, shortness of breath and dizziness.  It lasted only 3 minutes or so.  It didn't need any medical attention. The anxiety continued till 7:00PM.   With this event, do I still have to obtain the second dose after 21 days?
Patient stated her throat started tingling and she thought it was feeling like it was ready to start closing and she usually takes Benadryl.  Administered 25mg of liquid Benadryl.  The patient waited 30 minutes and stated she felt fine.
This case was reported by a physician via call center representative and described the occurrence of chills in a 71-year-old male patient who received SHINGRIX. On 18th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 19th January 2018, the patient experienced chills, influenza like illness, general physical health deterioration and arthralgia. In January 2018, the outcome of the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain were recovered/resolved. The reporter considered the chills, influenza like illness, general physical health deterioration, arthralgia and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to manufacturer. This case was reported by the physician who himself was the patient. The patient experienced severe pain and tenderness at the injection site (right deltoid) which started the evening after the vaccination. The next day, the patient began to experience shaking chills, severe arthralgia, and stated that he felt extremely fluish, like he wanted to die and was totally laid up. The reporter gave permission to be contacted regarding his experience. He was unable to provide the lot number and expiration date for the product administered.
On the above date and time previously stated,(nine days after first vaccination) I experienced diarrhea, nasal drip, gas symptoms in addition to the urge to defecate. Rectal discharge consist of loose stool and an odorless - clear mucus concentration minus any indication of blood. Frequent toilet visits consisted of 7 to 12 times in a 24 hour period. Bowel issues appeared to be improving during the week of March 28 through April 3rd. My original symptoms have since returned on 04/08/2021 (seven days after second vaccination). I have had no fever with exception to the day after second vaccination, no weight loss, no stomach pain, no fatigue and no change in diet since the onset of these symptoms.
pt states vomited 2 days ago & once yesterday, not today at all; pt states is emotionally distraught;  pt states caught a cold-thinks has temp but hasn't taken it w/thermometer; t97.8, lungs very wheezy; SOB, poss rapid speech, & smoking;
Immunocompromised patient was given a booster dose instead of a 3rd full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029A21A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Drug allergy, Drug allergy, Drug allergy, Renal cancer (Currently receiving immune therapy treatment.), Coronary artery disease, Hyperlipidemia and Hypertension.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 15-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose). On 15-Nov-2021, ACCIDENTAL UNDERDOSE (Immunocompromised patient was given a booster dose instead of a 3rd full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  No side effects noted after administration.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant follow-up appended - Medical history is added
patient came into clinic with 103.4temp. then it went up to 105.0 temp at this time. Poor appetite and not and refusing to eat. patient sent to the hospital by ambulance.
Sore arm after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after 1st dose) in a male 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 an unknown date, the patient experienced MYALGIA (Sore arm after 1st dose). At the time of the report, MYALGIA (Sore arm after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.