chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 12 hrs of 1st puncture of vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was opened on 15 Jun 2021 morning around 9:30am and was used for that day and then it was put back to refrigerator and then next day on 16JUN2021, it was taken out of refrigerator and was used from that vial between 10:40am-3:30pm No relevant concomitant medications were reported.. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Mother alerted pharmacists before administration that their daughter experiences syncope with needles. The mother sat by her side as I administered the vaccine. The patient said that the vaccine hurt and sat their for about 5 minutes . At that time the patient said she did not feel well and laid on the ground. It is unclear if patient passed out for a few seconds. I spoke with patient to make sure she was conscious and then monitored her to look for signs of anaphylaxis. Her symptoms appeared to by related to anxiety rather that anaphylaxis. The pharmacy did call 911, but the patient and her family turned down the emergency service. I sat with patient for about 45 minutes to monitor her condition. When she improved they decided to leave that pharmacy. I did suggest they be looked at by a physician. We also called and check on patients well being and she seems to be doing fine.
Muscle aches localized to arm and joints that persisted past three weeks. Muscle rigidity noted by health care provider at 3 weeks and it is noted to be more swelling and rigidity than normal.
PATIENT COMPLAINS OF DIZZINESS AND NAUSEA WITH NO DIFFICULTY BREATHING. PATIENTS VITALS OBTAINED BP- 96/64, HEART RATE 57, RESPIRATIONS 18, O2 SAT 97%. PATIENT MONITORED AND ADDITIONAL 15 MINS AND PROVIDED SNACK AND DRINK. PATIENT MONTIORED ADDITONAL 15 MINS AND STATES FEELS BETTER AND REQUEST TO GO HOME.
Lightheaded, racing heart, tighness in chest,some difficulty breathing deep breathes-shortness of  breath, rash on face and neck, BP was elevated.   Treated by EMS-Benadryl IV, breathing treatment.  Transported by ambulance to ER  Felt Ok after 3 hours in Emergency room. No meds given there.
deep chills 4 hrs, fever of 101 for 6 hrs,  headache, fever off/on plus chills for 48 plus hrs. greatly exasperated my asthma which was under control into needing steroid inhaler for a month plus many other remedies to calm lungs and be able tp breath. asthma includes shortness of breath, deep coughing with nothing in lungs, pain in lungs/chest.  greatly inflamed several other chronic inflammation conditions some after a month still have not receded.  exclusively breastfeeding at time of both injections baby reacted like she had shots, aggravated the reflux, decreased milk supply reactions lasted more than a week.
Pt woke 6/10 day after vax, with pain in left shoulder and neck, extending, distally to hand. Movement was painful, ache constant with episodes of sharp pain, and paresthesia. Next day pain extended across anterior chest wall. On 6/12, pain extending from shoulder to left side of chest and into left hip. He had extension into left lower extremity to the foot. No focal deficit. He seemed better later in day with Ibuprofen. Left deltoid swollen with erythema, heat and induration. Had weakness of left upper extremity grip.
Headache; Blurry vision; Chills; Shortness of breath; Very tired (been in bed for 2 days); Body aches; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 50-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 05Apr2021 at 20:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram (MANUFACTURER UNKNOWN) and bupropion hydrochloride (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took promethazine (PHENERGAN) and experienced drug allergy. On 19Apr2021, the patient experienced headache, blurry vision, chills, shortness of breath, very tired (been in bed for 2 days) body aches and stomach pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, blurry vision, chills, shortness of breath, very tired (been in bed for 2 days) body aches and stomach pain were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the first Moderna vaccine IM left deltoid on January 23, 2021 and the next week developed redness, discomfort and swelling in the left arm. She had seen her dermatologist that week for another issue and the dermatologist was so concerned that she described Keflex. The patient was afraid to take the Reflex as she has a PCN allergy so she presented to  Urgent care. She has a cellulitis in the arm.  She has antihistamine a home and took one last night. I advised her to take it nighty until resolves and to start Clindamycin  po TID x 10 days to treat cellulitis and also may take Famotidine prescribed by her physician which she had not started yet and may use OTC cortisone cream on area.
The evening after receiving FLUMIST patient began with sore throat, stuffy nose, headache and body aches. No specific treatment has been needed.
Significant heartburn. Also, sore arm from about 8pm, till I went to bed that night.
RED, HOT TO HOUCH, SWOLLEN. AUGMENTIN 600MG ES
24 hours after DAPTACEL in left upper arm developed swelling that extended to mid scapula and mid forearm with heat, pain and fatigue that lasted a full 48 hours.
Rash the size of a golf ball, had redness after the vaccine for 2-3 days with general soreness but no other symptoms. When I woke this morning my arm was again rashy around the vaccination site but with itchiness this time.
Initial information received on 07-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who experienced swelling and redness two inches below, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 05-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AD via unknown route. On an unknown date, The patient developed a non-serious swelling and redness two inches below. (vaccination site inflammation) 2 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was swelling and redness two inches below. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for swelling and redness two inches below..
Starting 06/01/2022, I had mild congestion, coughing, phlegm in the throat x 3 days. I tested positive on 06/02/2022. While the symptoms only lasted for 3 days, I kept testing positive for about 8-9 days. My wife had it a few days before me.
Severe uncontrollable shaking; temp 102.2f, unable to move arm, deltoid very hot & swollen. This lasted for 72 hrs.
Had tiredness, fever 99.8, headache and feel achy hours & day after but developed 'COVID Arm' rash & itchiness on 3rd day as well as cold sores on my lips of my mouth (3of them).
Patient developed fevers the day after vaccine, arthralgias/myalgias.  daily fevers persisted, and he was eventually admitted to the hospital for FUO workup. fevers finally stopped after prednisone initiated on 3/11 (3 weeks after vaccine) presumed Still's disease type phenomenon from vaccine (has high ferritin, high WBC, low albumin, mild LFTs abnl, persistent fevers), never had rash
Possibility that vaccine was overdiluted with 1.8mL instead of 1.3mL prior to administration
sleepy/feeling sleepy; flu like thing/flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy/feeling sleepy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like thing/flu like symptoms". Additional information: After getting vaccine, had flu like symptoms day after, was feeling sleepy. These things pretty typical, has had this experience with Pfizer vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, Arthralgia, Diarrhea, fatigue, chills, stomach pain Narrative:  Other Relevant History:
Mixed series. First dose Pfizer on 6/9/21 lot #EW0180
Did not take the last dose of Vivotif; Spontaneous report received on 11FEB2020.  A pharmacist reported that a female consumer who "did not take the last dose of Vivotif" (PT: Product dose omission). She was taking the Vivotif for immunisation. On an unknown date, the consumer took first and second dose of Vivotif according to schedule. On 07FEB2020, the consumer took third dose of Vivotif as per the schedule. The consumer did not take the last and fourth dose of Vivotif. Action taken with Vivoitf with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer did not take the last dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer did not take the last dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
Information has been received from a nurse and follow-up information was received from a physician concerning the nurse's 76 year old mother who on 25-JUN-2007 was vaccinated with one dose of ZOSTAVAX (Oka/Merck) (lot no. 656413/1477F).  Concomitant therapy included PREMPRO and SYNTHROID.  On 09-JUN-2008 the patient first experienced severe pain in her right leg which was followed by a shingles rash on her right side within twenty four hours.  The rash has resolved but the patient has "splotches" where the rash was and was experiencing numbness in her lower right leg.  The physician reported in follow up that "the patient did not have an adverse event.  She had a breakthrough case of shingles in the sciatic distribution and post herpetic neuralgia".  At the time of this report, the patient was not recovered.  The patient was seen by the physician to seek unspecified medical attention.  The physician considered a breakthrough case of shingles, numbness in the lower right leg and post herpetic neuralgia to be other important medical events.  Additional information is not expected.
Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: patient experienced fogginess, drowsiness and confusion. was sent to the ER-Severe; symptoms lasted 0 days
Telephone call from grandmother states infant is lethargic and has been since vaccine. He wont wake up. But she did say he has taken a bottle. Instructed to take infant to ER or Dr. immediately.
Patient reported dime-sized circle of warm redness on the left arm at site of injection and a quarter-sized warm redness one-quarter inch below injection site.
08/19/2005 started crying at 10:30 the previous night non stop crying for 4 hrs. Took to ER. ER physician diagnosis with constipation. Back for recheck in office today. No further problems.
Arm is red; Nod at arm; Sitff; Achy; Flu; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy), INFLUENZA (Flu), ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy) and INFLUENZA (Flu). On 13-Feb-2021, the patient experienced ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm). At the time of the report, MUSCULOSKELETAL STIFFNESS (Sitff), PAIN (Achy) and INFLUENZA (Flu) had resolved and ERYTHEMA (Arm is red) and INJECTION SITE NODULE (Nod at arm) had not resolved.            Treatment information included just drank plenty of water.  Concomitant medications included Prescription Eye drop.
This case was received from a nurse and forwarded by Crucell, No: CVAE-049-2013. An initial report was received from a nurse on 26.Aug.2013 and concerns a 63-year-old male patient who, on 17.Aug.2013, received the first oral administration of VIVOTIF (batch no: not reported). The patient's medical history was reported as insulin-dependent diabetes and post-colorectal cancer. It was noted that on 31.Jul.2013 the patient received ZOSTAVAX. No other concomitant medications were reported. On 19.Aug.2013, following the second oral VIVOTIF administration, the patient developed a very dry mouth and slight constipation. It was noted that the patient continued with the VIVOTIF and completed the course of 4 pills. On 26.Aug.2013 the patient was admitted to hospital because he continued to have bowel blockage. No further information was available. At the date of the report, the outcome of the events was unknown. The events were considered serious (hospitalisation).
Patient came to pharmacy indicating after the first dose of MODERNA COVID vaccine was administered Friday 10/09/2021 the next day she started to feel bad with fatigue, chills, nausea, chest pain and needed air. She went to the hospital for care and was given oral pump.
Arm swelling; muscle pain and weakness. Nausea flash at time of injection. Muscle pain and arm weakness persists
Recipient contacted Health Department on 10/15/18 reporting lingering left arm pain since flu vaccine administration. Reports pain, poor range of motion and inability to sleep on left side. Sought private physician evaluation and was sent for orthopedic evaluation. Reports she was cleared of any orthopedic anomaly and was prescribed anti-inflamatory medications.
Rash with hives at injection site approx 3inches in diameter had pt ice area and Benadryl 25mg qid for 1 day inspected area 10-12-13 at pharmacy raised welt at injection site approx 2&1/2 inch in diameter pt reports no itching and mild pain with no fever.
The gentleman reported that his arm felt "locked up" the evening after receiving the shot for which he went to the doctor.
Redness, swelling, warmth in oval shape 4"x3" on right thigh.
Patient vaccinated with Pfizer COVID vaccine on 1/27/21 and 2/22/21. Patient and spouse became ill early Sept and admitted to outside hospital with a positive NP collected 9/6. Patient discharged from hospital 9/8 but readmitted to current hospital on 9/9. Patient received dexamethasone but doesn't believe he received remdesivir from the hospital he was admitted to on 9/6. On admit to current hospital patient has had progressive shortness of breath and productive cough on presentation to ED. Admit diagnosis is acute hypoxemic respiratory failure and patient remains admitted at time of submission
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # N011491 with expiry date: 04-NOV-2018 (dosing details, route and anatomical location were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 32 degree Fahrenheit to 35 degree Fahrenheit for a duration of 23 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. Follow up information has been received from a medical assistant on 26-SEP-2017. The reporter stated that she had faxed the patient identifiers and dates of vaccination a month ago after she made the call. The medical assistant stated that she would refax them. Follow up information has been received on 04-OCT-2017. On 22-AUG-2017, a 71 years old patient of unknown gender was vaccinated with improperly stored PNEUMOVAX 23. This is one of 8 reports received from the same reporter. Sender's Comments: US-009507513-1708USA011337: US-009507513-1710USA008711: US-009507513-1710USA008712: US-009507513-1710USA008713: US-009507513-1710USA008714: US-009507513-1710USA008716: US-009507513-1710USA008717.
Around 4pm I started to feel body aches, then I started to feel like I was freezing. By 11pm when I went to bed, I felt like I had the coronavirus again. I slept with my night gown, heavy bathrobe, my sheets, comforter and another blanket and I was still freezing and achy. When I woke up the next morning, I was sweating so profusely the it was dripping off of me and getting my gown wet like I had been working out and then got in the sauna. All I did was drink hot tea. I had no appetite or energy.
ADMINISTRATION ERROR: A Moderna Booster 0.25 mL was given by the Intradermal route instead of by the Intramuscular route when both a TB skin test and the Moderna booster were to be administered at the same visit.  Vaccines were administered by RN.
Patient received immunization on 5/22/2006 and began running fever on 5/23/06. Fever was up to 103.7 R.
Pt. states that her shoulder hurt, she had a fever, and pain level was 9. She said she developed a rash and the area was hot and bright red.
Consumer stated she only received one dose because her physician told her she only needed one dose; Consumer stated she already asked her physician, and he did not know and suggested she restart the series if she would like two doses.; No additional AE reported.; This spontaneous report was received from a consumer, referring to herself, an adult female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis. Consumer stated she only received one dose because her physician told her she only needed one dose but she read the varicella virus vaccine live (oka/merck) (VARIVAX) patient information (PI) that stated adults need two doses. Varicella virus vaccine live (oka/merck) (VARIVAX) PI section reviewed with consumer. Consumer referred to reach out to her physician and that her physician could provide further guidance. Consumer stated she already asked her physician, and he did not know and suggested she restarted the series if she would like two doses (product prescribing issue and inappropriate schedule of product administration). No additional AE reported.
No additional AE; Caller stated the ROTATEQ that underwent a temperature excursion was administered to 9 patients; This spontaneous report was received from a medical assitant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot number 1707306, expiration date 26-DEC-2021 (dosage regimen was not provided) for prophylaxis. No adverse event was reported.      The vaccine underwent a temperature excursion as follows: between 36 degrees Farhrenheit (°F) and 46°F with an average of 46.9°F for 30 minutes. The call was due to digital data logger. There were no previous tempreature excursion.
Nerve twitching on my face above left corner of mouth, an almost daily occurrence that may last up to one or two minutes.
Information has been received through the Merck Pregnancy Registry from a 41 year old consumer concerning her 9 year old daughter, with a history of drug exposure in utero in NOV-1996 with varicella virus vaccine live (Oka/Merck). The mother, at 31 years of age, reported receiving varicella virus vaccine live (Oka/Merck) early in her pregnancy. The number of weeks gestation at the time of the vaccination was not known. (Original Case# 638799). The mother reports that her daughter has been healthy, but does have a speech impediment at the present time. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Patient had swelling, redness, and warmth at the injection site. Counseled patient to take benadryl until it goes away.
had COVID; had COVID; She is in the early stages of dementia; she can't walk; This is a spontaneous report from a contactable consumer (patient's husband). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), at unknown vaccination age via an unspecified route of administration on 05Jan2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. He reported that she got the first dose of Pfizer's COVID-19 vaccine on 05Jan2021. Right after, she ended up having surgery, then was in rehab, and had COVID. She was discharged 2 weeks ago (unspecified date in 2021). He inquired if she can still get the second dose. She is in the early stages of dementia, she had trouble from the second night, she can't walk, she's in a wheelchair all the time. The outcome of the events was unknown.  Information on the Lot/ batch number has been requested.