chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     It was reported that patient received other vaccine in the 4 weeks prior to COVID-19 vaccine and also had received Synergist injection on 07-Mar-2023.  Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE. Past adverse reactions to the above products included No adverse event with PNEUMOCOCCAL VACCINE.    On 09-Mar-2023 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023 at 11:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered 12 hours post puncture, vial was first punctured on 08-Mar-2023 11:30 AM and was administered on 09-Mar-2023).    Concomitant drugs were not reported.  It was reported that 1 dose monovalent vial for 6 months to 5 year of unsure size 10 dose of 0.25 5 was initially stored in refrigerator on 23-Feb-2023 at 02:30 pm, was first punctured on 08-Mar-2023 at 11:30 am and was administered on 09-Mar-2023 at 11:30 am. The vial was stored at room temperature post puncture for 24 hours. The vial was not exposed to temperature excursion.   Treatment medications were not provided.
Tuesday afternoon May 31 I had a dull headache and scratchy throat. I tested positive that day. Wednesday I did not want to get out of bed. I had a low grade fever. Thursday it was pretty much the same with body aches, nausea, headache, flu symptoms and I still had a fever. Friday I had all of the same symptoms but I could feel it go into my chest. I called the doctor and had phone interview. She prescribed PAXLOVID. I began taking it on Friday. By the next morning the fever had decreased. I felt a bit better. Saturday afternoon the fever was gone and most of the flu symptoms were gone but I was very tired. Sunday and Monday I felt better and the following days I was getting better but was unable to do move about as normal without fatigue. The following week I was fine except major fatigue would hit me out of nowhere and I would have to just sit and rest for about an hour.
loss of muscle control in both arms, restless, high fever - 103.4 - 105.8 at one point, lethargic, lifeless, limp, blue around mouth, fingernails and feet, loss of appetite, fussy, easily agitated, thick green/yellow mucus drainage from nose and in back of throat
Fluzone was given 3 months earlier than indicated. RN administering thought he was giving a different vaccine. There were no adverse event as a result of this error. Patient was evaluated by a provider immediately following administration. Patient remained asymptomatic throughout. Patient left the clinic without further incident.
large local reaction (7.8cm) w/central vesicle formation; hx of large local rxn to first Hep B vax;
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 22-MAY-2015, the patient was vaccinated with GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 18-APR-2016, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) (interchange of vaccine products). No adverse symptoms were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
patient states the day after the vaccination she experienced rash and spots at site of injection and states they are painful and red but not itchy.    I followed up with her today 3 days post vaccination and she states the arm is blotchy with a red color but that it is fading and getting better.  She claims no issue with movement or pain today.
temp to 105 PM of 4FEB & off & on until 6FEB; no redness or swelling of inject site; no excessive/high pitched cry; afebrile 7FEB-14FEB; mild runny nose 7FEB-14FEB;
anaphylactic shock; severe itching; tingling in my extremities; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jul2021 07:45 (at the age of 80years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included known allergies: fish, seafood; No chronic health conditions. There were no concomitant medications.  The patient previously took Medrol, Cephalosporins, Naprosin, Celebrex, and class c cortisones (neomycin sulfate) and experienced allergy. The patient did not have Covid-19 prior to vaccination. On 14Jul2021 20:00, the patient experienced eight episodes of severe itching and tingling in her extremities over 6 days. Upon each onset she took 50 mg of Benadryl. Within a half hour she was better, but she was afraid as she gets anaphylactic shock. The patient was not tested for Covid-19 post vaccination. The outcome of events as recovering.
The site of injection was swollen, red and tender for a couple days.  Then it stayed red and itchy until March 23.
Information has been received from a physician concerning a 65 year old female patient, who on 25-OCT-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # and expire date not reported), 0.5 ml, intramuscularly. On 26-OCT-2010 the patient experienced a severe locally reaction to PNEUMOVAX 23. The patient noticed the reaction the next evening (on 26-OCT-2010). The patient was experiencing redness, swelling, tenderness and warmth. The area was approximately 6 inches wide and wrapped around her biceps. The patient sought unspecified medical attention. At the time of the report, the patient had not yet recovered, also reported as "recovering". Additional information has been requested.
hives that started on his foot and they moved up to his legs and his abdomen.; itching; This is a spontaneous report from a contactable consumer (patient) reporting himself. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EW0179) via an unspecified route of administration in Arm Left on 08May2021 as second dose, single dose for covid-19 immunization. Medical history included, high blood pressure, Allergy, kind of dry eye also have bulging disc at his back, squeezing out to the nerve that why he have to chair, phlebotomy. Patient had took first dose of BNT162B2. Concomitant medication included amlodipine besilate (NORVAS) taken for high blood pressure, atorvastatin (LIPITOR [ATORVASTATIN]), losartan (LOSARTAN), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an for heart, amlodipine (AMLODIPINE), verapamil (VERAPAMIL), hctz (HCTZ), cetirizine hydrochloride (ZYRTEC ALLERGY) taken for hypersensitivity, gabapentin (GABAPENTIN), oxycodone (OXYCODONE),metoprolol succinate (TOPROL XL), ascorbic acid (VITAMIN-C). The patient reported that he received his second dose of the vaccine on 08May2021 and later began noticing hives that started on his foot and they moved up to his legs and his abdomen he saw his primary care physician who prescribed a cream for the itching, but itching hasn't gone away and doesn't know if he should get checked out at the emergency room because the hives are still bothering him or if they will just go away. Upon follow-up (22May2021), event reported as he got reaction almost from this Pfizer vaccine, he was asking should he have to go to emergency room and he got hives popping up different places on his body and it like a really bad. He went to doctor yesterday they said they don't know what is going on, he thought what could be the vaccine, we don't know, past they told me hives is the side effects, then he have been on phone for a last couple of hours, and gotten anywhere, he is not getting anything from doctor or anybody. Last Saturday his foot broke out just once but now just same keep coming all over his body and he took to the doctor they said they don't know where it's coming from, so he think with that part of shot picks it up vaccine what led him to do. He still have concern about hives over his body, it is itching little bit. It was started last sunday on the 16th. This just started after he had the vaccine, he had not it before. Consumer stated, he just want to know if I need to to go to the emergency room, do he need to worry about it. The patient underwent lab tests and procedures which included blood test. Therapeutic measures were taken as a result of itching (pruritus) with Loratadine. The outcome of events was unknown.  Follow-up actions are required. Further information requested
Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 17-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 09-Feb-2022 and Dose 2 administered on 17-Mar-2022) outcome was unknown.            No concomitant medications were reported. It was reported that the daily dose of HUMIRA(Solution for injection in pre-filled pen) was given as citrate free. On an unknown date patient blood work was done which showed no inflammation, rheumatoid arthritis those markers were fantastic. It was unknown if patient was enrolled in COVID-19 vaccine trial. No treatment medications were provided.   This case was linked to MOD-2022-570161, MOD-2022-570179, MOD-2022-570086 (Patient Link).
Patient received Pfizer COVID vaccine and waited for 30 minutes after to observe for reaction.  Within the 30 minute waiting  period, she felt like her lips and tongue were tingling and her throat was scratchy.  She denied shortness of breath, chest pain, difficulty swallowing or difficulty breathing.  Vital signs were stable.  Due to her history of anaphylaxis reaction with various medications and shellfish, she was taken to the ER.  In the ER she received IV Solu-Medrol, Benadryl and Pepcid and her symptoms resolved.  She was observed for 6 hours and then released to home.
developed pleurisy and pneumonia started with pain in side and became accute over a 9 days Accompanied by fevers, aches, headaches Zpak, pain killers, oxygen,levofloxcin, azithromyacin, ceftriaxone, naCI, fentanyl, hydrocodone, hydromorphone,
1HR POST VACCINATION SORENESS DEVELOPED IN LEFT ARM, REDNESS STARTED AT THE INJ SITE AND BY YESTERDAY MORNING HAD SPREAD TO HER ELBOW. PT STATES SHE HAS SWELLING IN HER LEFT AXILLARY LYMPH NODE. ALSO C/O HA SINCE YESTERDAY. PT STATES SYMPTOMS HAVE IMPROVED SINCE USING COLD PACK ON ARM AND TAKING IBUPROFEN YESTERDAY. IN CLINIC FOR EVALUATION, REDNESS NOTED AT INJECTION SITE, LEFT DELTOID AREA WITH MILD BRUISING NOTED AT SITE. WARM TO TOUCH. REDNESS IS NOTED APPROXIMATELY 1.5" ABOVE AND 4" BELOW INJECTION SITE. LEFT AXILLARY NODE IS SWOLLEN, AS WELL AS ENTIRE AXILLAE, TENDER TO TOUCH. NO REDNESS AT AXILLAE AREA. INSTRUCTED TO CONT COLD PACK/IBUPROFEN AND F/U WITH MD IF NOT IMPROVING IN 24HR.
Gushing blood from her vagina; Extreme fatigue; Started cramping really badly; Stated that she has been having the worst period of her life; Cramps are so intense they make you sweat; This is a spontaneous report from a contactable consumer, the patient. This case is created for second dose. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), dose 2 via an unspecified route of administration, administered in arm on 01Jun2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8735), dose 1 via an unspecified route of administration, administered in arm on 11May2021 (at the age of 32-years-old) as a single dose for covid-19 immunization. There were no medical history and concomitant medications. No other products, patient history, investigation assessment were reported. The patient ever since she got the vaccine that she has been having the worst period of her life and was reported as worsened. Stated that if she knew this would happen she would have never got it. Is for the Pfizer Covid vaccine. A few days after the shot on the 01Jun2021 that it started and she was cramping really badly and gushing blood. Stated the cramps are so intense they make you sweat. She just started her period again and was experiencing the same thing. She had extreme fatigue. She stopped gushing blood two days ago when her menstrual cycle ended. Stated that she noticed the gushing blood during her period. She started spotting on 03Jun2021 and gushing blood on 04Jun2021. Stated that she recovered completely because her menstrual cycle stopped. The cramps feel like contractions and are so bad that they make her sweat. Later clarified that she was having these issues with the first dose but she wanted to document the start date as being after the second shot because she was not keeping track of all of this. None treatment was reported. Outcome of the event vaginal haemorrhage and sweaty was unknown; while that for others was not recovered.
Itching, pain, swelling and inflammation at injection site of anthrax vaccine on right arm lasting three days.
hands and feet also were cold/ had chills; "COVID arm" around the injection site.; hardness at that site and swelling; COVID arm" around the injection site., big donut sized raised hives; COVID arm" around the injection site., big donut sized raised hives and rash; hardness at that site and swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives) and VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) in a female patient of an unknown age 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling). At the time of the report, FEELING COLD (hands and feet also were cold/ had chills), VACCINATION SITE REACTION ("COVID arm" around the injection site.), VACCINATION SITE INDURATION (hardness at that site and swelling), VACCINATION SITE URTICARIA (COVID arm" around the injection site., big donut sized raised hives), VACCINATION SITE RASH (COVID arm" around the injection site., big donut sized raised hives and rash) and VACCINATION SITE SWELLING (hardness at that site and swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications was reported Treatment information was not provided
Dizziness, Headache, lightheadedness Narrative:  1/20/21: Pt c/o headache while on 15-min observation; VS taken (0909am) BP 134/98. HR 90, OsSat 100%; given water; observed for another 15mins; VS retaken (0925) BP 125/76, HR 89, O2sat 100%, T - 98.3; c/o lightheadedness & dizziness; brought to ED
23SEP93 reddened ears, rash on face w/in a few days, bumps on knuckles, eyes puffy & watery & rash on front of legs; dx measles;
Dtap #5MMR #2IPV #4 on 31 July 03 -Child received vaccination in well child check-up MOP noted swelling and local erythema at injection was instructed if increased another 1 ½ this size the child would need to follow up 1 Aug 03- Child told mother leg was uncomfortable MOP examined area and noted "4 inch" erythema and local swelling; no fever, itching, or other problemsMOP took child to ED; child was admitted for "cellulites"; very late at night child was "sleepy" otherwise acting appropriately 2 Aug 03 -Child received IV antibiotics pending lab studies that were taken in the ED; no fever, itching, and acting appropriately 3 Aug 03 - MOP reports decrease swelling and erythema; no fever, itching, and acting appropriately 4 Aug 03 - MOP reports only swelling present; no erythema, fever, itching, and acting appropriately 5 Aug 03 - MOP reports no swelling, erythema, fever, itching, and acting appropriately
Severe pain in left arm, limited function in left arm for several months.  Unable to lift anything over 5lbs. such as my purse, couldn't reach and/or carry items during a normal day.  Had to use Vicodin for the 1st 3-4 days. after that NSAIDS 1 to 2 times a day for a month or so.
Developed a pustule on his forehead, concerned that he may have spread infection from the site of his smallpox vaccination.
He had his vaccine in different state while visiting his daughter.  Returned home and was found to have a blood clot behind his left knee.  Also, he called the doctor last week and told him that he believes he has another one above the left ankle.  He has an appointment on Thursday to see him again.   He had two venous ablation procedure in both legs in late November/December of 2020.   He was taken off of the baby aspirin and then put on Xarelto.  The 2nd possible blood clot appeared about 10 days ago above the left ankle.
The patient "felt tired and ache"; The patient "felt tired and ache"; This is a spontaneous report from a contactable physician via a Pfizer sales representative.  A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 in Dec20202 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient "felt tired and ache" on Jan2021 The outcome of events was recovered.  The patient did not received treatment due to the events. The events were considered as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Roughly one week after my first Pfizer shot I developed tinnitus. Has resulted in a high-pitched ringing in ears. It was in both ears three weeks following the shot and is now mainly in by right ear.
Had hives within 4 hrs after receiving varicella vaccine. rec'd benadryl and the hives gradually disappeared next day.
The vial placed in refrigerator was on 26-Sep-2021 and administered vaccine on 29-Oct-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial placed in refrigerator was on 26-Sep-2021 and administered vaccine on 29-Oct-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial placed in refrigerator was on 26-Sep-2021 and administered vaccine on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (The vial placed in refrigerator was on 26-Sep-2021 and administered vaccine on 29-Oct-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The health care professional reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response code was scanned. It was reported that patient had no temperature excursion and no adverse event.  No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).