chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial put into refrigerator 11/01/2021. used beyond 31 days.
I had my shot done on 01/26. On Feb 08, I left to go visit my daughter. My plan was to be there for 4 months. In Feb, probably around the 20-22, I started having problems with my breathing. I blamed it on possible the pollen or possibly the humidity. I did some extra breathing treatments and it didn't seem to be working. I did that until March. I called my pulmonologist and they prescribed prednisone. That was the middle of March. The prednisone worked. I came back home in May. I called them and they put me on another round of prednisone because I was still having trouble. As of June, yesterday, I went for my testing, and the lady that did my breathing test was worried because I wasn't sounding good. Today, they called and put me on another round of prednisone. I'm on a callback list to see my pulmonologists. I had testing in December when I was sick and none of this was going on then.
itching; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS and VACCINATION SITE RASH in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE RASH. On 23-Apr-2021, the patient experienced PRURITUS. At the time of the report, PRURITUS and VACCINATION SITE RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment information was reported.
After 5 minutes of the shot, patient fainted & hit his head on the ground. we called 911 afterwards, then the paramedics took him around 1:15 pm
Muscle soreness; Profound fatigue/exhaustion; Mild headache; Agitation; This is a spontaneous report from a contactable pharmacist. A 23-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL1284 , intramuscularly on 22Dec2020 14:45 (at the age of 23-years-old) as a single dose in the left for COVID-19 immunization. Medical history included anxiety, insomnia, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS). The patient had allergies to medications doxycycline, mupirocin, and intolerant to garlic and onion  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) 20 mg, sertraline 150 mg, clonazepam 1 mg everyday at bedtime (QHS), melatonin "ER" 10mg QHS (every bedtime), montelukast 10mg HS (at bedtime), famotidine 20 mg twice a day(BID), pantoprazole (PANTOPRAZOLE) 20mg once  day (QD), ondansetron 8 mg three times a day(TID) as needed (PRN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital.  On 23Dec2020, the patient experienced muscle soreness, profound fatigue/exhaustion, mild headache and agitation.  The events muscle soreness, Profound fatigue/exhaustion, mild headache and agitation  did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the events. Outcome of the events muscle soreness, profound fatigue/exhaustion, mild headache and agitation was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
minimal soreness in arm; I had slight light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2021 10:00 (Lot number: EN5318) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2020 (unspecified if ongoing), notes: I may have had COVID-19 in January of 2020; "spurred by asymmetrical cortical thinning of the right hippocampus lobe from birth oxygen depravation" (unspecified if ongoing), notes: spurred by asymmetrical cortical thinning of right hippocampus lobe from birth oxygen depravation; "fatigue" (unspecified if ongoing); "fever" (unspecified if ongoing); "dry cough" (unspecified if ongoing); "Seizure", start date: 2000 (unspecified if ongoing), notes: I have been taking Dilantin since 2000 for a seizure I had then. Concomitant medication(s) included: DILANTIN [PHENYTOIN] taken for seizure, start date: 02Jan2000 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Jan2021 10:05, outcome "recovered" (27Jan2021), described as "minimal soreness in arm"; DIZZINESS (non-serious) with onset 27Jan2021, outcome "recovered" (Jan2021), described as "I had slight light headed". Therapeutic measures were not taken as a result of pain in extremity, dizziness.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts completed. No further information expected.
Information has been received from an approximately 30 year old male consumer (now 31 year old) with no pertinent medical history and no drug reaction or allergies who on approximately 10-DEC-2009 "on about 10-DEC-2009", was vaccinated IM with 10 mcg dose of RECOMBIVAX HB (Lot# not reported). There was no concomitant medication. The consumer stated that he thought he had received the third dose of the three part series on about December 2009. The consumer's physician only had a record of two parts of the series. The consumer also stated that his titers were low when he checked nine months after receiving the last dose on 10-DEC-2009. The consumer's physician recommended him repeat the three part series. At the time of the report, the patient's outcome was unknown. The consumer sought unspecified medical attention. Additional information has been requested.
Immediately after receiving vaccine PT. felt hot/dizzy. PT. moved to private treatment area. History and vitals obtained. PT. monitored and after approx. 10mins, stated she felt Better. PT monitored full 30mins. PT. stated she was better and ready to go home. PT. released and advised to call 911 w/ any further problems. Feeling hot,dizzy. Immediately after receiving vaccine PT. felt hot, lightheaded. PT moved to private treatment area where vitals and history obtained. PT. started feeling better after approx. 10mins. PT. monitored for 30mins. PT. started she felt better and was ready to go home. PT. released and advised to call 911 w/any further problems.
Hospitalization for acute hypoxemic respiratory failure, COVID19 PNA 2/4/22-3/2/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg daily, vitamin D 1,000 units daily, zinc 50 mg daily.
This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes. Digital Data logger was involved. The dose of PROQUAD underwent two separate temperature excursions: the first on 18-APR-2016 (also reported as on 18-APR-2017) and the next on 03-FEB-2017 (also reported as first one). No product quality complaint was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916.
diarrhea, vomiting, chills, fever of 103 degrees F.  Went to ER for IV fluids and antipyretic.
Chest pains, left side Higher than normal heart rate (resting heart rate over a month increased by 10bpm)  Went to urgent care: EKG normal CT scan normal  Went to ER: X-ray normal EKG normal Possible plurisy or myocarditis diagnosis
Shortness of breath/ wheezing which was made better with 1 puff of albuterol. This is the first time I have had to use my inhaler in 3 years, so the only thing that was different is that I got my COVID shot a few weeks prior.
Mild injection site tenderness; Booster third dose; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 11Oct2021 at 09:30 (at the age of 68-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine inact sag 4v (FLUAD QUAD) via unspecified route of administration in the left arm on on 25Sep2021 for immunization and included unspecified multivitamin and ibuprofen (MANUFACTURER UNKNOWN) (over the counter); both for an unknown indication from an unknown date and an unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 18Jan2021 at 19:00 (at the age of 68-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 08Feb2021 at 16:00 (at the age of 68-year-old); both as a single dose for COVID-19 immunisation. On 11Oct2021 at 17:00, the patient experienced mild injection site tenderness. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 23Apr2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the event mild injection site tenderness was not resolved at the time of this report.
ials that were put in the fridge and after that refrozen and thawed; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (ials that were put in the fridge and after that refrozen and thawed) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (ials that were put in the fridge and after that refrozen and thawed) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (ials that were put in the fridge and after that refrozen and thawed) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (ials that were put in the fridge and after that refrozen and thawed).    Case contains the information regarding patient 95 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Headache; Swollen arm; Itchy arm; Red hands; Arm was Hot to touch; strained, tired eyes and fely heavy; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands) and FEELING HOT (Arm was Hot to touch) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands), FEELING HOT (Arm was Hot to touch) and ASTHENOPIA (strained, tired eyes and fely heavy). On 10-Apr-2021, HEADACHE (Headache), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy arm), ERYTHEMA (Red hands), FEELING HOT (Arm was Hot to touch) and ASTHENOPIA (strained, tired eyes and fely heavy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment information not provided.
Mom called 08/17/2005 immunizations given 08/09/2005. Excessive crying started 08/15/2005 night et day. Noticed increased jerky movement in arms and legs since immunization. Denies seeing these movements prior to 08/09/2005. Will hit self in the head frequently. Going to hospital 08/18/2005 for under developed trachea. (mother called Dr. bout the crying.
This spontaneous report has been received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The reporter stated that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M032493, expiration date 06-JUL-2018; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent (MRK) injection (lot number and expiration date were not reported). The vaccine data logger measure, on unknown dates, a temperature ranges from 6 degrees Fahrenheit (F) to 14 degrees F for a total time frame of 1 hour and 30 minutes, and another one of 15 degrees F to 46 degrees F for 2 hours and 20 minutes. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Mild tingling and numbness on right side of face beginning 25 to 30 minutes after getting the vaccine.  Right eye began watering later in day.  Noticed watering eye after taking 1/2 of a 10mg Zyrtec that evening.  This morning,  3/14/2021, the watering right eye continues and the numbness and tingling in right right side of lips continue.   The symptom to rest of right side of face appears to have dissipated.   The best way to describe it is the feeling to face and lips is it feels similar to the feeling when Novocaine is wearing off.
Initial and folow-up information has been received from a health professional concerning her 11 year old black daughter with asthma and seasonal allergies who on 14-SEP-2007 was vaccinated into the right arm with a first dose of Gardasil.  Concomitant vaccination on 14-Sept-2007 included a first dose of MENACTRA into the left arm and a first doese of diptheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (lot # c275pAA) into the left arm.  Other concomitant therapy included montelukast sodium (MSD), albuterol and cetirizine hydrochloride (ZYRTEC).  On 14-SEP-2007 the patient experienced swelling at the injection site, stomach ache, sore throat, and fever of 102.5 F with headache.  On 15-SEP-2007 the patient was seen in the emergency room.  Temperature was 101.9, pulse was 114, respiration were 20 and unlabored, pulse oximetry was 98 percent on room air and pain was rated 8/10 in multiple areas.  She was diagnosed with pharyngitis.  The patient was discharged home.  A prescription was written for amoxicillin and caretaker was advised to administer ibuprofen and acetaminophen according to instructions provided.  The patient was advised rest and to drink extra fluids. Subsequently, the patient recovered from the injection site swelling.  The patient's dizziness lasted for four days and headache lasted for five days.  The reporting healtth profession was not sure if the patient's experience was related to the vaccine. Additional information is not expected.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX from lot# N008827 with expiry: 16-MAR-2019 (dosing details not reported) for prophylaxis. Concomitant medication included sterile diluent (MERCK). The vaccine stored at  9 degree Celsius to 8 degree Celsius for 38 minutes. The vaccine had no previous temperature excursion and the temperature excursion was detected by data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA003205.
Administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported. On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient received 4th booster dose. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Vial did not undergo any temperature excursions. The Vial was not stored  in the refrigerator, they were directly thaw from the freezer before administration
NO ADVERSE EVENTS, GIVEN DOSE AS BOOSTER SHOT DESPITE PATIENT'S AGE BEING 17
Nausea, Vomiting, Headache, Left arm pain, unable to lift arm, lymph node swelling under left arm, All over joint pain, All over muscle pain, Double vision, Left side abdominal pain, Left sided lower rib pain, Pain option inhalation, Jaw pain, Ear pain, Throat pain, Neck pain, Left breast pain, Facial pain
Pfizer-BioNTech COVID-19 Vaccine EUA: When first noticed the morning of the 3rd day after the vaccine I had a red circle about the size of a silver dollar that was vey itchy.  It is now early evening and the itchiness persists while the red circle is about twice in size.
Fever (101-102 F); chills; body ache; lethargic; a weird tingling sensation on her butt, leg, and back; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; stomach cramps at night; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685 and expiry date: 21Mar2021), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 in Jul2020. The patient's concomitant medications were not reported. The patient mentioned she had the 1st shot on Tuesday (05Jan2021) and woke up during the night with stomach cramps but didn't put it together that the cramps may be from the vaccine. She went to work on Wednesday and around 1pm in the afternoon (06Jan2021), she started to feel feverish with chills and aches; just was not feeling good. She experienced fever (101-102 F), chills, and body ache. When she got home around 4:30pm, her temperature was 101, so she took acetaminophen (TYLENOL) for it. During the night, her temperature went up to 102. She stated that she felt like she did when she had COVID in Jul2020, including being lethargic. She also had a weird tingling sensation on her butt, leg, and back. The weird sensation down her back, butt, and legs felt like "tingles that runs through you." She has heard others describe it as being like icy hot. She also noticed redness, hardness, and swelling at the injection site. Yesterday, she tried applying ice to her arm, and last night she had trouble sleeping because she still had the aches and chills. Today, her arm was larger and the red area has spread and it's hard. She clarified that it had been hard the whole time she's had the redness and swelling. She reported that the swelling on her arm was larger and harder, and the red area has spread. She also had a fever (101.6 F), chills and body ache, so she's getting ready to take some more acetaminophen (TYLENOL). She was starting to get concerned because it's been 3 days (72 hours) since she got the vaccine and she thought that the side effects would be over with by now. She was asking if these are common side effects and how long should they last. She stated "I am a bit concerned with taking the 2nd dose after this. Are there any recommendations on this?" The outcome of the events was unknown.
ZOSTAVAX vaccine - rash & swelling with pain at injection site. Seeing MD on 9/17/12.
Site of administration appears to be below teh muscular area of the deltoid. Looks lower than it should. Area appears red , swollen.
Shortness of breath onset Monday night and continued for following 2 nights and went to ER on the third night. In ER T 98.3, HR 120bpm, RR 32, O2 sat 100% on admission, nasal congestion, coughing, worsens when supine. Discharged same day with Dx of resp. distress. Followed up by PCP on 12/19/13. Lungs clear, afebrile, Dx URI.