chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 21-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
I was six weeks pregnant when I got my second dose. On March 19th I had an ultrasound and the size of fetus was small but there was a heartbeat. On March 24th month after vaccination  at my scheduled ultrasound my doctor could not find a heart beat. I have had five other miscarriages. I had not noticed any other symptoms in the preceding month. I did have a fever the day I received my vaccine that was 101 degrees. The fever was gone the next morning and I had taken Tylenol. My due date 10/30/2021. I must also have been pregnant when I got the first dose.
Patient did not experience any adverse events, but a newborn received adult flu vaccine instead of hepatitis B vaccine.  No adverse events.  Hep B vaccine given the next day (2/11/22)
diarrhea, headache, shoulder and upper back pain, foggy head (confusion).  Headache and light-headedness continued over the next two days.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 65-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 (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No adverse reactions were reported by patient.
On Saturday the 12th she experienced fever, chills and a slight headache. And her arm was tender and felt heavy. It was swollen and slightly red. On Sunday she started having trouble breathing. She went to a Medical Center and they checked her vitals. They gave her an inhaler (Albuterol). She used that on Sunday. She still was having issues on Monday. She took a Benadryl hoping that would help. Tuesday she was still having breathing issues. She then went to her PCP, who ordered a chest X ray. It came back normal. Her doctor was concerned it may be a pulmonary issue.  The doctor told her to continue to take her inhaler. She tried taking a shower to get steam. She then took a medicine she was prescribed for her allergies to tree pollen called Montelukast 10 MG 1x daily. She also tried a daytime allergy medicine taken during pollen season. She started feeling better.
Approximately 30 minutes after vaccine administration, I began itching intensely all over my body.  I felt like I was covered in itching powder.  I broke out in hives / raised bumps all over my body and splotches on my face.  This adverse event happened shortly after I had been dismissed from the vaccine clinic.    once I realized what was happening to me, I took an antihistamine agent for few days until the itching subsided.  The rash on my face  would come and go for several months before completely clearing.    Subsequently, I have experienced joint swelling in my hands that is painful, preventing me from wearing my jewelry or bending my fingers at times.  I had an appointment with my new primary care doctor, on April 22, 2021 and reported my allergic reaction to the vaccine to her and asked her to report it and document in my chart.  I just learned this week that she never recorded this event my chart.
Slight soreness after vaccination then injection site was normal; Injection site was normal till yesterday when it became very itchy; A hard knot the size of half dollar has developed and site slightly swollen.; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient 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 09Jun2021 at 15:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously took propylthiouracil (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. 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 vaccination. On 17Jun2021, the patient experienced slight soreness after vaccination then injection site was normal till yesterday when it became very itchy and a hard knot the size of half dollar has developed, site is slightly swollen. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight soreness after vaccination then injection site was normal till yesterday when it became very itchy and a hard knot the size of half dollar has developed, site is slightly swollen were unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My neck started getting swollen and I was having mild difficulty of breathing and it started after 35 mins after receiving the vaccine. About an hour after the vaccine and not being able to breath, I started breaking out in hives all over the body, even in my ears and along my hairline. Felt like I was baking all over. It lasts for about 35 mins and then I went back to normal. I been having this hive breakout weekly and now in the last couple of weeks it has been two till three times a week. I never had this problem before taking the vaccine. I haven't seen my doctor as of yet. My appointment is January 14, 2022.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Subsequently the patient "developed a 4 cm by 4 cm bolus lesion on the tricep area of injection site". Physician would like to know if this was due to "shingles". The status of the patient was unknown. The patient sought unspecified medical attention. Follow up information has been received from a physician indicating that the patient had a rash at the injection site. Additional information has been requested.
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 20th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 4th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that the patient received dose of Bexsero that was already expired on 20th January 2022, which led to expired vaccine used. The reporter consented to follow up.
R57.0 CARDIOGENIC SHOCK 6/24/2021 CARDIOMYOPATHY, UNSPECIFIED R57.0 CARDIOGENIC SHOCK 6/24/2021 PALLIATIVE CARE R57.0 CARDIOGENIC SHOCK 6/24/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Information has been received from a physician, via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. In 2006, reported as "about 10 years ago", the patient was vaccinated with a dose of ZOSTAVAX 19400 Y (lot #, expiration date, dose number and therapy route were unknown). Concomitant therapies were not provided. The physician reported that on an unknown date, the patient developed swelling for two weeks at injection site that hurt tremendously. The outcome of swelling at the injection site that hurt tremendously was reported as recovered at the time of the report. No product quality complaint (PQC) was involved. This is one of two reports from the same source (MARRS # 1608USA008887). Additional information is not expected as no consent to follow up was given.
Patient called it "COVID Arm": stated her arm has a red rash, swelling, and is itchy; Patient called it "COVID Arm": stated her arm has a red rash, swelling, and is itchy; Patient called it "COVID Arm": stated her arm has a red rash, swelling, and is itchy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Patient stated that she just had her second vaccine. She went online to read some other data and it was helpful to her.  She wanted to share that she has "COVID Arm" also.  She wanted to help by reporting her symptoms so other people can see that it is okay and common. Patient called it "COVID Arm": stated her arm had a red rash, swelling, and was itchy.  She got her second dose of the vaccine on 08Apr2021 but the rash started on Saturday morning, 10Apr2021. It has gotten worse since Saturday (11Apr2021).  It is not as bad as getting hives.  She has been taking pseudoephedrine hydrochloride (SUDAFED) and paracetamol (TYLENOL) like is recommended on the website and her arm has been bearable.  Stated the rash, swelling and itching has stayed just on her arm.  It's just a side effect, it's normal. Outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
TC from pediatrician office (practice name unknown).  Spoke with RN (Name unknown), who reported that client had a rash at the Pentacel injection site (LAT) that spread over entire body.  Client was seen in an ER on 12-9-14 per RN.  RN stated that client was treated with Zyrtec and prednisone.  Plan per RN is to refer client to an allergist for follow-up.  RN stated she would call me back later 12-11-14 to complete VAERS report.  Have not heard from her.
PATIENT STATED THAT THE VACCINATION WAS ADMINISTERED TOO HIGH. SHE IMMEDIATELY FELT PAIN DURING AND AFTER INJECTION. OVER THE COURSE OF DAYS, THE PAIN IN HER RIGHT SHOULDER DID NOT GET BETTER AND ONLY GOT WORSE. SHE SAW A NURSE PRACTITIONER WHO DIAGNOSED WITH PATIENT WITH SIRVA. PATIENT WAS GIVEN STEROIDS. SAID SHE HAD RELIEF OFF OF STEROIDS BUT IS NOT BETTER. SHE HAD HER ARM IN A SLING AND SAID SHE COULD BARLEY MOVE IT AND WOULD BE NEEDING AN MRI.
Her leg is also hot to touch; Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear; She began sleeping all day, only getting up to drink water.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (She began sleeping all day, only getting up to drink water.), BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear) and FEELING HOT (Her leg is also hot to touch) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 059E21A) for COVID-19 vaccination.     The patient's past medical history included Fatigue (No history of cardiac problems Cardiac related signs and symptoms: Fatigue). Concurrent medical conditions included Seizure (She had 2 shunts in her head that drain into her stomach.), Fibromatosis and Neurological disorder NOS (She had an extreme neurological disorder.They said she wouldn't live past 5 years old.).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (She began sleeping all day, only getting up to drink water.). On 14-Sep-2021, the patient experienced BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear). On 16-Sep-2021, the patient experienced FEELING HOT (Her leg is also hot to touch). At the time of the report, SOMNOLENCE (She began sleeping all day, only getting up to drink water.), BLISTER (Her leg blew up real bad from fluid/couldn't even see her baby toe/ I stuck a pin in her baby toe to burst the blister. A lot of fluid came out./Fluid still leaks out/Fluid is clear) and FEELING HOT (Her leg is also hot to touch) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
High fever, sore throat, chest congestion, cough, sinus congestion, worst headache ever, vomiting, like I got the flu. My husband got his shot at the same time and had the same symptoms. Today, we are both still sick.
PT BEGAN FEELING LIGHT HEADED WITH MODERATE CHEST TIGHTNESS AND DIFFICULTY BREATHING APPROX 20 MINUTES AFTER RECEIVING VACCINE.  WHILE ASSESSING PT BECAME LETHARGIC AND RESPONSIVE TO PAINFUL STIMILI ONLY.  INSPIRATORY AND EXPIRATORY WHEEZING NOTED TO ALL FIELDS UPON ALSCULTATION.  ETCO2 UNDERVALUE AT 17 MM/HG.   ALL OTHER VS WITHIN NORMAL LIMITS
Patient was given two vaccines(Menactra and HPV) and she looked pale after administered the vaccine, thus this nurse had her rest several minutes on an exam table and then moved her to the hallway (waiting area) into a chair.  This nurse returned to the vaccination room and heard a thump.  Client was found on the floor with an episode of syncope for approximately 15 to 30 seconds and then became responsive to verbal stimuli.  Client made to rest on the floor for a minute before getting up and then she returned to her chair for questioning.  Client hit her head on the floor during her episode of syncope and thus was taken to the Emergency Department on the second floor of this hospital for evaluation where she was released after examination by Dr.  No apparent injury noted.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient got lightheaded and fell from the chair while waiting for 15minute period after vaccination. Patient got scrap next to the left eye. Per patient and patient caregiver patient has expereienced lightheadness/dizziness with previous vaccinations. Patient informed no headache or pain afterwards
Having serious side effects; not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was having serious side effects and patient just wanted to make sure if it's normal or patient should get concerned. The patient was not feeling well on an unspecified date. The event outcome was unknown.
Nerve and Muscle pain, fatigue,  constantly getting sick. Sever muscle pain in back , calves, feet and toes
itchy rash; Hot to the touch; "lobster red" on his whole torso/bright red; blotchy rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (blotchy rash), RASH PRURITIC (itchy rash), FEELING HOT (Hot to the touch) and ERYTHEMA ("lobster red" on his whole torso/bright red) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH MACULAR (blotchy rash). On an unknown date, the patient experienced RASH PRURITIC (itchy rash), FEELING HOT (Hot to the touch) and ERYTHEMA ("lobster red" on his whole torso/bright red). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (blotchy rash), FEELING HOT (Hot to the touch) and ERYTHEMA ("lobster red" on his whole torso/bright red) was resolving and RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  HCP recommended to wait for the second dose.
Fever to 102.4.  Chills.  Shaking.  Generalized body aches.  Injection site pain down arm. Tachycardia of 120 beats per minute. Pulse ox was 96%. Weakness. Nause
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 UNK. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-025114 (Patient Link).
Normally regular menstrual cycle was irregular after receiving 1st dose - period was 7 days late
Client called to report reaction to vaccine. After she had vaccine on 1/11/21 she had soreness in the injection site which improved after a couple days. On 1/18/21 injection site had a sharp pain and a red spot that itches and continues to grow in size. She states its the site of a softball. She also developed dizziness on 1/22/21 and vertigo on 1/23/21. She had an allergy shot in the same arm 3 days after the COVID  vaccine.  She has an appt with her primary care this afternoon.
Pt. states that after receiving the 2nd dose of Moderna 08/28/2021, started experiencing symptoms 09/18/2021 of intense continuous ringing and popping in the (Right) ear. Hearing is affected with a low cloudiness sound with functionating hearing loss. No noted Primary visit/communications.
Chills, 101 fever , headache, body aches, swollen arm at injection site Symptoms present for 16 hours Tylenol taken  - 2x500mg twice at 6-hr. intervals Sore arm lasted 5 days
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. The patient was vaccinated with first dose of VARIVAX (merck) (Lot#, dose, route unspecified) on 09-NOV-2012. On 10-DEC-2012 the patient received an expired dose of VARIVAX (merck) (Lot# reported as 1695z, Exp date as 09-DEC-2012, dose, route unspecified) which was the patient's second dose. No adverse effect reported. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Swollen arm with hardened red circular area going outward around vaccine site. Tender to touch and itchy at times.
Sore arm developed on day of vaccine, and entire arm was achy the next day. Possibly mild fatigue the next day, but nothing severe.
Patient was supposed to receive the Pfizer 12+ Bivalent Booster, but received a dose of the Pfizer 12+ monovalent vaccine instead. Medical assistant accidentally pulled the wrong vial of Pfizer covid. Patient's PCP aware of the situation. No harm to patient.