chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 56 years 4 months.  No concomitant medications were provided by the reporter.  It was reported that vaccines were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment medications were provided by the reporter.
Patient was administered Moderna vaccine on 8/11/2021. Patient was then administered Pfizer vaccine on 9/8/2021.  Reporting that patient did not complete a series of Moderna (dose 1), because Pfizer was given as dose 2.
RASH UNDER POINT OF ADMINISTATION  ABOUT 1 IN CH BELOW
Caregiver was in the observation room for her 30 minutes but two minutes (11:29am) after her stay, she developed itching on her back,  redness on her chest and a burning feeling in her chest. At 11:33 she also c/o itching of the scalp.  BP:  139/69, HR: 99, RR: 16 and Sao2: 100% on room air.  Caregiver stated her itching was getting worse.  At 11:35 caregiver given 60mg of Fexofenadine PO per protocol for itching in back and head.  At 11:40, caregiver states neck was itching as well but no swelling, difficulty breathing or shortness of breath.  AT 11:54 BP: 117/48, HR:75, RR: 14 Sao2: 100% on room air.  When using a scale system to rate itchiness, caregiver states itching in back is 4/10, neck is 4/10,  head is 5/10 and chest burning rated 4/10.  At 12:10, caregiver states the itching in her back and neck was gone rated 0/10.  She also states chest burning was gone rated 0/10 and only had slight itchy feeling in head  rated 1/10.  At 12:20 the itching was resolved.  BP: 119/47, HR: 70, RR: 14, Sao2: 100% on room air.  Caregiver states she feels "back to normal."  Caregiver allowed to leave observation area.  Gait steady.  No complaints voiced.  Occupational Health manager aware of situation and involved in treatment plan.
Flushing and sweating - started 10-15min post-injection, lasted about 1 hr  Chills, nausea, malaise- started 45min post-injection, lasted 8-9 hrs  Injection site pain, joint and muscle pain (severe) - started 12 hrs post-injection, has not yet abated and has been 38-ish hours
No additional adverse effects were reported.; one patient received improperly stored PROQUAD on 2/4/2020; Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 04-FEB-2020, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength and route were unknown; dose 0.5 milliliter, once, lot # S030208 and expiration date 25-MAR-2021) for prophylaxis, which was reconstituted with properly stored sterile diluent. On 03-FEB-2020, the vaccine was exposed to temperature excursion between 47 degrees Fahrenheit to 77 degrees Fahrenheit (9 degrees Celsius to 25 degrees Celsius) (8.7 degrees Celsius) for 2 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Info has been received from an RN concerning a 38 year old female who received "MMR" as a child and on 2/12/03, was vaccinated with a dose of MMRII, (lot 644030/0858M). Concomitant therapy included complete series of Hep-B virus vaccine rHBsAg (yeast) twice (in 2003 and 2004). On 6/21/05, lab data revealed that serum Hep-B surface antibody screen and Rubella titer were negative. Unspecified medical attention was sought. The pt's outcome was unknown. Additional info has been requested.
Pain,  temporary blindness,  reduced  visual fields ( tunnel vision) and headaches . Later,  after treatment and the  passage of time, sensitivity to light  and  reduced vision in both eyes.
Pt. While waiting in 15 min waiting area lost consciousness, fell forward in chair, and hit his forehead. Pt lost consciousness for 10-20 seconds. Discharge RN's rolled patient over to assess airway. Pt regained consciousness  and reported no chest pain. Alert and oriented x4. VS: BP 125/70 HR: 39 O2: 98% R 14. EMS called  and transported to hospital. Pt reported baseline HR in 50's,
Case was vaccinated with 2 MRNA Covid vaccines, then was hospitalized for Covid.  Hospitalized at: Hospital  * Pneumonia due to COVID-19 virus Assessment & Plan Presented with two days of fever, myalgias, and cough. Tested positive for covid although she is fully vaccinated. O2 sat was 90% on room air initially and CXR did not show any infiltrate but she initially gradually worsened and needed 3.5L at worst. CTA on 9/19 showed small GGO's in both lungs and focal areas of infiltrate vs atelectasis in the lung bases but no PE, consistent with COVID-19 pneumonia. She is bothered by general fatigue and weakness, low energy, and found the symptoms gradually improved. Also bothered by hoarseness which is improving. She has had no persistent fever, chills, appetite is improved and she is ambulating as usual with use of walker. On the day of discharge still intermittently using 1 L/min oxygen supplement by nasal cannula for hypoxia, home oxygen will be prescribed. COVID-19 pneumonia with hypoxia was treated with dexamethasone 6 mg daily and remdesivir x5 days. She will return to taking hydrocortisone at home, recommending through October 1 she take 20 mg twice daily instead of 20 mg in a.m. and 15 mg p.m. Discussed symptoms may indicate she benefit from additional dose steroid dosing as she recovers   Acute respiratory failure with hypoxia  Assessment & Plan She earlier in stay had tachypnea, o2 sats recorded down to low 80s, reuired up to 3.5 L by NC to correct, associated mild encephalopathy. Secondary to covid 19 pneumonia.  -trending toward improvement by o2 sat and supplement needs at 1 L/min
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Aug2021 10:30 (Lot number: FC3180) at the age of 28 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID-19, brand= Pfizer, lot number= EW0198, lot unknown= False, administration date= 24Jul2021, administration time= 10:00 AM, dose number= 1), administration date: 24Jul2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 14Aug2021 22:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain, chills, and headache. The patient did not have treatment for adverse event. Prior to Covid-19 the patient did not have vaccination. The patient did not tested for Covid-19 after post vaccination. No follow-up attempts are possible. No further information is expected.
Parosmia/alteration of smell and taste. There is a constant rancid scent to everything and most food has had its taste altered considerably for the worse. Horrid taste and smell causes constant discomfort and at times mild nausea.
Welt around injection spot. Redness. Inflammation. Warmth. Tenderness.
chest constriction after 2nd dose for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest constriction after 2nd dose for 30 minutes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Shoulder pain and Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, CYCLOBENZAPRINE for Muscle relaxant, LEVOTHYROXINE and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (chest constriction after 2nd dose for 30 minutes). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and IBUPROFEN at a dose of Took before bed.. On 20-Mar-2021, CHEST PAIN (chest constriction after 2nd dose for 30 minutes) had resolved.            This case was linked to MOD-2021-374705 (Patient Link).
pt recvd vax; fever of 39.6 C; screaming but not high pitched; seen in ofc; otitis med also devel;
First dose, z track was done, zero pain, only discomfort at injection site the next day.  2nd dose: skin was pinched, immediate 3/10 pain after injection, radiating to left side of my neck. It became a dull pain 2/10 in my neck until two days post-injection while arm pain worsened to 5/10. There is a 3mm red ?dot? at the injection that appeared about 2 hours after injection.  Fever (101F) started about 10 hrs after injection, lasted about 48 hrs, Tylenol ATC. The next day, arm pain was 8/10 and there was redness about 3x3 inches, swelling, and stiffness under the site. Skin became more red and swelling present x2 days. Day three, skin was less red, but itchy, swelling resolved. 9 days later, skin is still itchy and area is still a faint pink vs rest of arm.
Patient described full body rash. Did not report any itching or discomfort but just erythema
Patient showed up to receive second dose at clinic and explained that 48 hours after their first dose, they experienced hives on one side of their body.  Patient notified their MD.  Second dose was not administered.
Approx 6-10 min after shot was seated and grabbed head and said "ow.. ow..." and then slumped over in chair unconscious. Was passed out and non responsive. Staff laid him on his back and raised his feet. Face was pale/white and lips were blue. Not responsive and unconscious for about 30 seconds to 1 minute. BP was low and heart rate elevated. Was weak and slight confusion. 911 called and taken to ER by ambulance. Was administered oxygen and IV fluids. Has NEVER had a reaction to any vaccine before. EKG taken at hospital and BP/HR?oxygen monitored. Discharged that night.
Right arm injection site reaction, erythema, edema, induration, tenderness and warthm worsen with spread to upper forearm.
Headache; Body ache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), MYALGIA (Body ache) and NAUSEA (Nausea) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
Arm was red and inflammed and painful.  Pain radiated from her arm up her neck with swollen lymph node.
This is an unconfirmed spontaneous report from a lawyer referring to a 71 year old male who claims to have experienced knee swelling after the 3rd Lymerix shot. The pt had no history of Lyme disease or arthritis. In March, April and May of 1999 the pt received Lymerix shots and immediately following the 3rd injection, the pt's knees swelled up so badly that he had to use a cane. He has since tested "DR4 positive". Treatment was not specified. The most recent information received on 2/17/2000 reports the outcome of the events as lessening but still present. Additional information has been requested.
Fully vaccinated, not boosted.   Mild symptoms  COVID + for admit to deliver and uncomplicated vaginal delivery of full term baby boy. Per MD. (Privacy) is a Term  appropriate for gestational age male     Weight: 3.17 kg (6 lb 15.8 oz)     38 6/7 weeks  Apgars 9/9    Both mom and baby same PCP.
No symptoms observed while patient was present in pharmacy. Medication was still in vial after attempted administration.
Flu-like; Bad hangover; Fatigue; Malaise; Nausea; Stomach pain; Body aches; Chills; Sore arm on side of injection; Axillary lymphadenopathy; Light-headedness; Headache; This is a spontaneous report from a non-contactable other Healthcare Professional (patient) reported for herself. A 20-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 at 15:45 pm (age at vaccination was 20 years) as dose 1, single for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient did not have any known allergies. Concomitant medication included spironolactone taken for an unspecified indication. The patient previously took flu vaccine and had minor local reaction to flu vaccine annually. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 18Feb2021 at 04:00 am, the patient experienced flu-like, bad hangover, fatigue, malaise, nausea, stomach pain, body aches, chills (no fever), sore arm on side of injection, axillary lymphadenopathy, light-headedness and headache. All symptoms onset was in the morning after vaccination (about 12 hours later) and were improving 24 hours after symptom onset. No treatment was received for the adverse events. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID-19 PCR test (nasal swab): negative on 18Feb2021. The outcome of the events was resolving.   No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment given to patients.
Headache, Myalgia & Fever Narrative: Day 1-3 Chills, headache, body aches and fatigue.
A non-serious spontaneous report of we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 11-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. The original expiry date was 12-Feb-2010 which was changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Soreness of upper arm started almost immediately--severe chills, body aches, slight temperature started around 5:00 pm--headache started in the middle of the night. It felt like I had the flu, minus any stomach issues. Additionally, I have tenderness (like nerve sensitivity) near the area that I had shingles 7 years ago--it feels like the beginning of shingles again. The feeling is at my inner left thigh. Hoping this "nerve sensitivity" goes away soon! I think I'm over the worse of the flu-like symptoms--will try to go into work later today.
Is 17 years and 11 months old, one month short of the recommended 18 years of age.  No adverse reactions have been reported from the patient at this time.
57 y/o Female patient received SHINGRIX vaccine in her L arm on Thursday 29 March 2018/, the next day patient noticed swelling and soreness in the area. Pt also experienced chills and a fever for 2 days. Pt presented to clinic today 02 April 2018, with bruising and redness in the deltoid area and travelling along the inner bicep muscle.
After receiving the GARDASIL vaccine, I had a routine pap smear at age 18. At this time, they found suspicious cells on my uterus, and recommended I get another pap smear every 6 months to 1 year. Every time I received a pap smear, I had concerning cells (they were monitoring for change that could indicate cancer). Had I never received this 3 series of injections, I would have had a normal pap smear. They were starting to lean towards the idea of biopsy in order to check for cancer.
No adverse effects reported; Received an improperly stored dose; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs, drug reactions and allergies was not provided. The patient's concomitant therapies included sterile diluent.   On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(rha) lot # R004441, expiration date 12-AUG-2019 (strength, dose, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature range of -14°C to -10°C (-14.3°C) for 2 hours and 7 minutes. There was previous temperature excursion from -14°C to -10°C (-12.8°C) for 51 minutes and from -9°C to 8°C (-8.2°C) for 37 minutes. It was reported that digital data logger was involved. No adverse effects were reported.  This is one of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA009915: US-009507513-1905USA012682: US-009507513-1905USA012683:
Pt received PNEUMOVAX at 9:30 PM and at 6:00 AM on 10/13 pt reported a red band around the arm redness and swelling to elbow. Advised pt to take BENADRYL and put ice on the area. Arm is better but not normal on 10/15/10.
Six days after injection patient began having heart palpitations at random times throughout the day/night. Palpitations often occurred at rest and occasionally would awaken patient in the middle of the night. Patient monitored blood pressure throughout duration of events and blood pressure was in normal ranges. Blood pressure did increase by 5-10 points on both systolic and diastolic, but still within acceptable ranges. Palpitations continued for approximately seven weeks before dissipating and eventually ceasing.
Left upper deltoid 2 1/2 inch redness, slightly raised left upper deltoid inch redness, slightly raised itchy, fever - degree unknown- parents do not have thermometer.  Slight bluing of lips - grasping neck as if couldn't catch breath, parents gave Benadryl, no symptoms of difficult breathing.
SWELLING, REDNESS, A LITTLE WARMTH. PT WENT TO URGENT CARE THE FOLLOWING DAY, WAS GIVING CEPHALEXIN AND SWELLING STARTED GOING DOWN IN TWO DAYS.
pericarditis; SOB; facial edema; wheezing; flushing; tachycardia; received the first dose of BNT162B2 via subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (Lot Number: EJ1686), subcutaneous, administered in right arm on 20Jan2021 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunization.  Medical history included penicillin allergy and COVID-19 on 28Dec2020. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 13:30, the patient experienced SOB, facial edema, wheezing, flushing, tachycardia and pericarditis. The adverse events resulted in Doctor or other healthcare Professional office/clinic visit, Life Threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included Epinephrine, prednisone, albuterol, diphenhydramine. The outcome of the events was recovered with sequelae.
pt recv vax SEP94; pt exp burning upon inj; 27SEP94 pt exp pain & swelling of rt deltoid; dx w/local inflammation secondary to the vax & treated w/soak & APAP; No further details were provided;
50mm erythema area at injection site 48 hrs later that is painful to touch and movement.
Severe dizziness leading to almost fainting, nausea, diarrhea, feeling like ice was flowing through veins while severely sweating, rushing noise in ears, difficulty standing without feeling faint. Lasted for about 30 minutes before being able to fall back asleep.
Severe joint pain in all joints. Painful even when lying in bed. Severe chills. Slight fever.
Experiencing pain to left arm since vaccine.  It hurts to get put on shirts.  It hurts to lift left arm.  It hurts to rotate left arm for stretching
pt recvd vax & w/in 24 hrs had a grand mal sz lasting 10 mins; to hosp stayed over night; t 39.7 C;
This case was reported by a physician via call center representative and described the occurrence of chickenpox in a 51-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (as a teenager). Concomitant products included SHINGRIX, thyroxine sodium (Levothyroxine) and metoprolol. On 4th June 2018, the patient received the 2nd dose of SHINGRIX. On 8th June 2018, 4 days after receiving SHINGRIX, the patient experienced chickenpox (serious criteria other: as per the reporter) and generalized rash (serious criteria other: as per reporter). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the chickenpox and generalized rash were not recovered/not resolved. The reporter considered the chickenpox and generalized rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient had the first dose of SHINGRIX on 24th May 2018. The patient received SHINGRIX in the left arm. The physician had a patient received 2nd dose of SHINGRIX and experienced a rash which started on her left arm and generalized from there. The rash had progressed and the physician diagnosed the patient with chickenpox in June 2018.