chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Employee developed numbness  lt face and lt facial droop 2 hrs after the flu injection' He was taken to the ED where he was given Deltasone 80mg po x 6 days and carboxymethylcellulose 1 drop to the left eye. He had no other symptoms.  He was stable no further progression of the paralysis.  He will be followed.  no restrictions. He reports that his mother had a similar reaction to flu vaccine years ago.
day 42 after first shot; A spontaneous report (United States) was received from a consumer for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273). It was know that the patient's second dose was scheduled for day 42 after first shot.  The patient's medical history was not provided. No concomitant product use was reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was at facility to receive the second shot of vaccine, day 42 after the first shot of vaccine. The facility ran out of vaccine.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, inappropriate schedule of vaccine administration, was resolved.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot# Unknnown ), and then experienced Inappropriate schedule of product administration with the second dose of mRNA-1273 (lot # Unknown) without any associated adverse events.
This spontaneous report was received from a radiologic technologist refers to an unspecified number of patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unspecified dates, the unspecified number of patient's were vaccinated with improperly stored doses of PEDVAXHIB (lot# M025193 and expiry date unknown) (dosage regimen was unknown). No adverse effect reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
About 2 minutes after receiving vaccine patient was seated on bench outside pharmacy, fainted and fell forward onto cement floor hitting his jaw. Patient was unresponsive for about 20 seconds while being attended to.  Once he regained consciousness, he was helped to sit back on bench. He was diaphoretic and claimed to have a racing heart and right hand tingling.  He lost consciousness on the bench again and lost bladder control. EMS was summoned and was on scene in 5 minutes.  Patient did not claim to have difficulty breathing.  Pharmacist called patient about 3 hours after the event and he was still in hospital with apparent problems keeping his blood pressure adequate.
Mon at 3:15 had PNE vaccine. Woke up Tues morning with pain and swelling with 4" long x 2" wide 4" high, accompanied by NALKLA, fatigue. By Wed arm doubled in size. PT TX hydrocortisone, Tylenol, Benadryl.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of M-M-R II (lot#, dose, route and frequency were not provided), which had underwent supported and unsupported temperature excursions, (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Started feeling light headed and achy around 4 pm following 7 am vaccination.  ?Pfizer-BioNTech COVID-19 Vaccine EUA. By 5:45 pm I had a fever (based on how I felt). I was away from home and got back around 7:15 pm and measured fever at 100.4 F. Took 2 liquid gel ibuprofen (regular over the counter dose) at 7:15 pm. Had chills, very achy, headache, joints popping in a way that is not normal for me. 8:44 pm now, still feel very hot. Able to eat and have been drinking lots of water. Realize now that malaise after first dose was a reaction. I feel as though I'll soon be feeling better but it's the sickest I've been in 2 years.
I made several attempts to wake patient, which is very uncharacteristic for her. She struggled to wake up, and when I finally was able to wake her, she was disoriented and struggled to communicate. Her struggles continued throughout the day. When she arrived home from school, she had developed a congested cough, appeared very distracted and unable to communicate as she normally would. She was very verbally and physically aggressive, had multiple meltdowns (uncharacteristic of her), and became very flushed at random points throughout the evening.  She was very irritable, unwilling to cooperate with anything I prompted her to do, and required full assistance with self-grooming tasks that she can normally perform independently.
PT received the FLU shot and RSV vaccine yesterday and woke up in the middle of the night with difficulty breathing. She does having a history COPD/Asthma and does use a CPAP machine at night. She said she never felt this way before even with her diagnosis. She wonders if it could be a reaction from the RSV vaccine. Followed up with pt 6 days later and Pt states she is feeling a lot better.. she saw PCP and got prescribed antibiotics and steroids for her copd exacerbation.
Patient developed pain and tingling in left arm. She noted left thumb and forefinger numbness. She also noted fever, diffuse body aches and joint aches followed by persisting left neck and shoulder pain which continues to the present.
This spontaneous report was received from a nurse and referred to a 3-month-old female patient. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided. On 27-DEC-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), (lot # 1691299, expiration date 25-DEC-2021, 2 milliliter), orally for prophylaxis. It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ), that had expired on Christmas (25-DEC-2021), was administered to the patient on 27-DEC-2021 (expired product administered) and the nurse wanted to know if a re-dose was needed or was it okay. There was no temperature excursion reported. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Patient reported noticing redness and swelling at injection site while in the shower. Presented to pharmacy 11/08/2015 to ask if reaction was normal.
No adverse event; Expired doses administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patient) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, NO ADVERSE EVENT (No adverse event) and EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patient) outcome was unknown. Not Provided      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 (Expired doses administered to patient).    No concomitant medication information was provided.  The vial was initially stored in refrigerator on 7-Jun-2022.  The vial did not undergo any temperature excursions.  The dates of administration of the vaccines was reported as 1Apr2022, 5Apr2022, 6Apr2022, 8Apr2022, 11Apr2022, 12Apr2022, 13Apr2022, 14Apr2022, 22Apr2022, 9Jun2022, 10Jun2022, 13Jun2022, 18Jun2022 and 22Jun2022.  The dates of vaccine administration were not reported and it was unknown whether patient took first, second or first and or second booster doses.  No treatment medication information was provided
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J006156 and expiry date 30-AUG-2014. Dose and route were unspecified. The reporter informed that a shipment (referred as second) of improperly stored ZOSTAVAX vials (lot number J006156 and expiry date 30-AUG-2014) received on 11-OCT-2013 were exposed to 5 degrees centigrade for approximately 41 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 8 of several reports from same reporter. Additional information has been requested.
she got diabetes; sugar levels spiked immediately after having first dose of Pfizer vaccine during 25th week of her pregnancy; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 15May2021 at 12:00 as dose 1, single (Lot number: EW0172) at the age of 29 years, in left arm for covid-19 immunisation. Date of last menstrual period: 17Nov2020. The patient was 25 weeks pregnant at the time of exposure to BNT162b2. The patient was 25 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 24Aug2021. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (hospitalization) with onset 16May2021 at 12:00, outcome "not recovered", described as "she got diabetes"; BLOOD GLUCOSE INCREASED (hospitalization) with onset 16May2021 at 12:00, outcome "not recovered", described as "sugar levels spiked immediately after having first dose of Pfizer vaccine during 25th week of her pregnancy"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Maternal Exposure During Pregnancy, second trimester". The patient was hospitalized for diabetes mellitus, blood glucose increased (hospitalization duration: 1 day(s)). Therapeutic measures were not taken as a result of diabetes mellitus, blood glucose increased. clinical course: Received BNT162b2 on 18May2021 at12:00 as dose 2 ,single (Lot number: EW0185), vaccinated to left arm. No known allergies.  No follow-up attempts are possible. No further information is expected.
Both arms got very sore when the pt went home and continued on up to this date; Pt's arm hurt when lifting any object. His right arms hurts the most.
large red raised bump, very warm and itchy occured on the fourth day after shot.  lasted a week
10 patients received Moderna vaccine that had thawed out and then refroze; 10 patients received Moderna vaccine that had thawed out and then refroze; The patients are all adults the patients have not reported other side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects). At the time of the report, PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze), POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze) and NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (The patients are all adults the patients have not reported other side effects) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (10 patients received Moderna vaccine that had thawed out and then refroze) and POOR QUALITY PRODUCT ADMINISTERED (10 patients received Moderna vaccine that had thawed out and then refroze).    No relevant concomitant medications were reported. No treatment medication reported.     This case was for the 4th patient out of 10 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743056 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743056:Master case
2 days later it came back and we are again positive; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "unknown", described as "2 days later it came back and we are again positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 19Aug2022 to 23Aug2022. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course information: Reported as, No other medication within 2 weeks. Both Patient and his wife had Paxlovid. After taken course they were negative however 2 days later it came back and they were again positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201114829 Same reporter/vaccine/event, different patient;
Achy and fatigued "I feel like I have the flu" no fever-exam done 8/17/18 normal follow-up call 8/21/18-pt doing well.
Aspirated blood in needle before injection, injection not given.  Needle withdrawn and immunization discarded.  New immunization prepared and given without complication.
Patient states right arm and shoulder are still sore greater than one month post injection. Flu shot was given in right deltoid.
Patient and patient's father both lied and said patient's birthday was early 2009 when the correct DOB is late 2009 in order to get patient the covid vaccination. When I discovered this and called the patient's father after they left (having received the vaccination) he confirmed patient's DOB is late 2009 and she is still 11 y/o. I told the patient's father she is not to receive the second dose until she turns 12 y/o per control recommendations.
Patient experienced strong localized reaction including itching, burning, and swelling at the site of injection. This patient and 11 others received undiluted Pfizer COVID-19 vaccine. No other adverse events were reported from the incident.
Went to ER 01/04/2006 notice left thigh swollen yesterday afternoon 01/03/2006. Area redness 6 inches x 4 inches. Left thigh 1-2 inches bigger than right thigh.
Since receiving the booster, I am having constant joint pain. Even though I am 72, I teach 4 nights a week and am very active. Why only now since the booster do I have such constant joint pain?; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 16:00 (Lot number: 5682) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Citrus, reaction(s): "known allergies: citrus". Vaccination history included: Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine brand unknown=False,, vaccine administration date=30Jun2021,, vaccine administration time=09:30AM,, vaccine lot number=0198,, vaccine lot unknown=False,, vaccine dose number unknown=True,, vaccine dose number unknown reason=UNKNOWN,, vaccine location=Left arm), administration date: 30Jun2021, when the patient was 72 years old, for COVID-19 immunization; Bnt162b2 (vaccine brand=Pfizer / BioNTech,, vaccine brand unknown=False,, vaccine administration date=21Jul2021,, vaccine administration time=09:00AM, vaccine lot number=7484,, vaccine lot unknown=False,, vaccine dose number unknown=True,, vaccine dose number unknown reason=UNKNOWN,, vaccine location=Right arm), administration date: 21Jul2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 20Jan2022, outcome "not recovered", described as "Since receiving the booster, I am having constant joint pain. Even though I am 72, I teach 4 nights a week and am very active. Why only now since the booster do I have such constant joint pain?". Therapeutic measures were not taken as a result of arthralgia.  Additional information: Reported that since receiving the booster, patient had constant joint pain. Even though patient was 72, she teach 4 nights a week and was very active. Why only now since the booster did, she had such constant joint pain? How can she remedy this? She did not take any other meds other than a blood pressure pill, 10 mg, every second day. Please advise sooner rather than later. Patient had known allergies: cillins, citrus, and numerous others.  No follow-up attempts are possible. No further information is expected.
chills Narrative: Patient is a 56-year-old male with history of paranoid schizophrenia, COPD/ emphysema, alcoholic hepatitis and alcohol use remission who presents  for ED evaluation of 1 day of pressure-like frontal headache with light sensitivity, myalgias, chills and fatigue, the symptoms are following the first Covid vaccine yesterday. Patient has not tried anything for the headache at this time, describes that is not different from his previous headaches. Does report some nausea without  vomiting.
Pt was given a dose of Moderna COVID 19 vaccine but it was found out pt had already received two doses of Pfizer COVID 19 vaccine shortly after administration of Moderna vaccine.  No adverse reaction noted.  Pt informed about the possible side effects of the vaccine - soreness on the site and flu like symptoms.  Incident reported the attending nephrologist, Medical Director and Director of Operations.
4 H after inj. flu like sx chills, diarrhea. 6-7 H after inj severe body aches. Took hot bath, ibuprofen PM. Awoke 7AM felt fine & has since.
injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; injection area is red, raised, warm, and itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy). At the time of the report, VACCINATION SITE WARMTH (injection area is red, raised, warm, and itchy), VACCINATION SITE PRURITUS (injection area is red, raised, warm, and itchy), VACCINATION SITE ERYTHEMA (injection area is red, raised, warm, and itchy) and VACCINATION SITE SWELLING (injection area is red, raised, warm, and itchy) had not resolved.        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.  No treatment information provided.
Patient received ZOSTAVAX vaccine on 8/26/2013. Called on 8/5/2014 to say she had been hospitalized due to contracting shingles.
Pt vaccinated with Influenza 1NOV90. On 2NOV90 developed pain in ear, traveling to jaw, then to throat; lasted until 4NOV90. Returned 14NOV90.
Pt described rash to left arm-from elbow to shoulder. Describes as sunburn appearance, itchy, warm to touch. Rash not witnessed by clinic-reported by phone call only 5/26/15.
Patient developed left clavicle lymphadenopathy, petechiae and hemangioma. Hemangioma resolved. Lymphadenopathy decreased in size, petechiae still present.
Soreness in arm 4/1/21 4:30 am to 4/2/21 7:00 am  Now less painful. Headache 4/1/21 4:30 am to 4/1/21 9:00 pm Now gone Aches in joints 4/1/21 7:00 am to 4/2/21 7:00 am Now gone  Tylenol 2 caps 4/1/21 at 12:00 pm and 7:00 pm and 4/2/21 7:00 am
Patient felt worst around 5 minutes after vaccine. I gave her 2 Benadryl 25 mg tablets and asked  if she had trouble breathing, said no. A few minutes later, patient said vision worsened so we called paramedic.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot # K009482, expiry date 06-MAR-2017 and lot # K011325, expiry date 08-APR-2017; strength, dose, frequency, route of administration were not reported), which were exposed to temperature outside of the recommended range. There were no concomitant therapies reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
pt recvd vax 26APR93 & 28APR93 lt deltoid w/large reddened area, raised & painful;
Red to pink papules, slightly itchy, scattered on BUE and BLE.  Resolved without treatment in 7-10 days.  Reoccurrence of similar symptoms on 05/16.
Patient received Moderna as D1 and D2 and then received Pfizer as AD in error, as indicated on this report. AD dose was given 12/09/2021 and error discovered today.