chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient presented for their COVID-19 vaccine 2nd dose on 6/9/21. The clinic was off site and documentation was not accessible. The patient's vaccine card stated their first dose was a Pfizer vaccine, but their documentation and paperwork completed on the date of their 1st dose (5/19/21) stated the patient received a Moderna vaccine for their first done. The patient was contacted and they noted their card stated Pfizer for both doses. The patient potentially received a mixed series of the Covid-19 vaccine, with possibly Moderna for their 1st dose and Pfizer for their 2nd dose.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT STATED FEELING UNCOMFORTABLE IN THE THROAT AFTER HER 15 MINUTE WAITING PERIOD WAS UP. PATIENT STATED THAT IT WAS MORE OF AN ITCH THAN SWELLING/TIGHTENING OF THROAT. PATIENT REQUESTED BENADRYL TO BE ADMINISTERED. 1 TAB OF 25 MG BENADRYL WAS ADMINISTERED. PATIENT BLOOD PRESSURE WAS ALSO MONITORED. PATIENT WAS KEPT FOR AN ADDITIONAL 30 MINUTES BEFORE LEAVING. FOLLOW UP CALL WAS GIVEN TO PATIENT APPROXIMATELY 40 MINUTES LATER AND PATIENT STATED SHE FELT FINE.
Moderna dose was drawn up and administered after recommended 12-hour punctured Beyond Use Date (BUD) but before recommended 24-hour room temperature unpunctured BUD.
Received the Pfizer COVID-19 vaccine this morning and, while walking back to work, experienced hypertension, tachycardia, diaphoresis, shortness of breath, anxiety and chest discomfort.  Code Blue was called; she received supplemental oxygen and was given Aspirin 81 mg.  Emergency Medical Services (911) were contacted and arrived at 11:45 AM.  She was assessed and an intravenous line was inserted.  She was transported to an emergency room and left this facility at 12:20 PM.  Update:  The employee was assessed and treated at Hospital.  She was not admitted; she was directed to follow up with her primary care provider and to seek a referral to a cardiologist.
joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication was provided. Treatment medication included Aleve.   This case was linked to MOD-2021-060448 (Patient Link).
Had severe migraines after each shot along with vertigo, blurred vision, nerve pain, weakness, upset stomach and diarrhea. Symptoms lasted weeks after first shot and about a week or two with second one with more severe weakness, gait dysfunction, vertigo, blurred vision, migraines, numbness, tingling occurring within 14 days.Spoke with general practitioner and neurologist. Began steroids 6/17/21 Bloodwork showed SARS-CoV-2SAb, Quant levels above 2500U/ml.Basically, homebound right now and unable to get around normally.
Severely itchy as in chew your arm off. Swollen from shoulder to elbow. Lymph nodes under arm tender.  Hot. Rest of body was 97.3 to 97.5 degrees. Arm was 99.9 degrees.  No difficulty breathing. Tired. Treated with ice and aloe. Did not take any OTC drugs or antihistamine.  Arm still swollen today but temperature down to 98.1 and itching is just an irritation. I had no problems at all with first dose. My sister said she had itching with her first dose so I did not immediately recognize it as an uncommon reaction. I just want this reaction documented
Hives on Saturday. Asthma, SOB, fever and diarrhea.
Vial of vaccine used had been opened and sitting at room temp (68 F-70F)at 3PM on 8/17/2021. Vaccine was given unsure of exact time, but sometime between 8AM and 12PM on 8/18/2021.
low fevers of 99.3 degrees which went up to 100 degrees; chills; had to go home from work, because he wasn't feeling well; having sweating, described as night sweats; slight soreness in his throat, which was not severe; soreness in his left arm; left nostril hurt; sinus pressure with a slight headache and aching near his left eye; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his left arm), MALAISE (had to go home from work, because he wasn't feeling well), NIGHT SWEATS (having sweating, described as night sweats), OROPHARYNGEAL PAIN (slight soreness in his throat, which was not severe) and PAIN (left nostril hurt) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN (left nostril hurt) and PARANASAL SINUS DISCOMFORT (sinus pressure with a slight headache and aching near his left eye). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in his left arm). On 07-Apr-2021, the patient experienced MALAISE (had to go home from work, because he wasn't feeling well), NIGHT SWEATS (having sweating, described as night sweats), OROPHARYNGEAL PAIN (slight soreness in his throat, which was not severe) and CHILLS (chills). On an unknown date, the patient experienced PYREXIA (low fevers of 99.3 degrees which went up to 100 degrees). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Pain in arm, at an unspecified dose and frequency. On 08-Apr-2021, PAIN (left nostril hurt) and PARANASAL SINUS DISCOMFORT (sinus pressure with a slight headache and aching near his left eye) had resolved. On 11-Apr-2021, OROPHARYNGEAL PAIN (slight soreness in his throat, which was not severe) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in his left arm) had resolved, MALAISE (had to go home from work, because he wasn't feeling well) and PYREXIA (low fevers of 99.3 degrees which went up to 100 degrees) outcome was unknown and NIGHT SWEATS (having sweating, described as night sweats) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Developed a rash on chest, groin and legs, 5 days, post vax. Rash appears to be chickenpox.
PULLED VACCINE AND DID NOT LOOK AT THE VIAL AT ALL. I PASSED THE VIAL OVER TO A COWORKER TO VERIFY/ DOUBLE CHECK ME AND SHE STATED THAT IT WAS THE RIGHT ONE AND THAT IT WASNT EXPIRED.
Severe cramping /tetany of the left hand that occurred approximately 24 hours after vaccination. Symptom onset was immediate and lasted for 45 minutes before resolution.
This spontaneous report was received from a registered nurse refers to a 15 year old male patient. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not provided. On 24-MAR-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # L015048, expiry date: 29-APR-2017). Nurse reported that the vaccine was stored at 26 degree Fahrenheit for a time frame of 18 hours which was outside of the recommended range (incorrect product storage) and administered to the patient. There was no previous temperature excursion. No adverse effects have been reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient called Pharmacy after receiving an injection 11-22-05 to report an injection site reaction. Painful, raised, swollen injection site circumference of 5 inches. Patient instructed to call physician as soon as possible for further evaluation.
Erythema that hasn't resolved after approximately 3 days.  Patient took antihistamine without improvement. Patient also had 101 fever and some arm pain.
No adverse event; Patient received the booster dose instead of the second dose of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient is allergic to Benadryl. Patient is taking medication for migraine (rizatriptan). Patient takes Clonazepam 3 times a day for anxiety and Trintellix for depression.;Question:Was there parental vaccine exposure?Answer:No.  Concurrent medical conditions included Migraine (Patient is taking medication for migraine (rizatriptan)), Anxiety (Patient takes Clonazepam 3 times a day for anxiety), Depression (Patient takes Trintellix for depression) and Drug allergy.    On 20-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 20-Dec-2022,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the booster dose instead of the second dose of the primary series).    No relevant concomitant medications were reported.  No treatment information was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 25Jan2021 as dose 1, single (Lot number: 029L20A), in right arm, on 28Feb2021 as dose 2, single (Lot number: 010A21A), in right arm and on 29Oct2021 as dose 3 (booster), single (Lot number: 939905), in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer", start date: 2010 (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Gentamycin, reaction(s): "known allergies: gentamycin", notes: known allergies: gentamycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: positive test after taking Paxlovid; Negative, notes: testing negative; unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Patient had Known allergies of amoxicillin, gentamycin.
Got my vaccine today  It hurt when the pulled the needle out  About 30 minutes after on my way home. My finger tips on my left arm went numb, same arm where I received the shot.  By the time I got home  I had a headache, so I took some tylenol.   My mouth is dry on and off. They told me to drink water and Gatorade  I slept for about 5 hours. I feel better but I still have a dry mouth.  The next morning my arm was swollen and itchy around the injection. I used an ice pack for the swelling.  About 24 hours later I was sweating on and off and my headache continued. I took another tylenol. And my body muscles were hurting.  I did not see a physician during any of the episodes.  It's the morning of March 23rd and I feel okay today.
pt broke out in hives <5min p/vax;also lips became swollen;no resp distress noted;family MD notified by mother;prescribed DPH x 24hr;pt & RN talked w/mom 730PM;hives & swelling decreased;
About 32 hours after receiving the vaccine, I started to itch severely all over my body.
This case was reported by a physician and described the occurrence of incarcerated inguinal hernia in a 2 month old female subject who received Pediarix. Medical history included hydrocele. On an unspecified date in 2/05, the subject received the 1st dose of Pediarix (lot AC21A010CA). On the same day, the subject also received vaccination with ActHib (lot UE474AA) and Prevnar (lot A65653C). At an unspecified time following the receipt of immunizations, on 2/28/05, the subject experienced "crying for more than 3 hours and was very fussy". The subject was seen in an ER. Physical exam revealed an inguinal bulge. The subject was dx'd with incarcerated inguinal hernia vs. vaccine reaction". The events resolved "after serveral hours" on 2/28/05. The events were not reported to the physician until the pt's 4 month check-up. The physician reported that, "the 4 month old dose (2nd dose) of Pediarix was held". The physician considered the events to possibly be related to vaccination with Pediarix and the "ActHib and Prevnar".
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 67 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/18/21 .   Tested positive on 3/26/21.   NOT hospitalized. "Positive COVID test on 3/26/21;  Negative COVID test on 3/28/21;  Negative COVID test on 3/31/21" none reported, tested due to contact with suspected/confirmed COVID-19? Unclear
STOMACH DISCOMFORT; This spontaneous case (PVX2019-910) was received from a nurse on 17-Apr-2019 for two consumers.   Based on the information obtained from the nurse, two individual case safety reports PVX201904-000300 (PVX2019-910; consumer 1) and PVX201904-000301 (PVX2019-910; consumer 2) were created and cross-linked in the database.  This case report describes an adult consumer who experienced stomach discomfort, after the administration of Vivotif for an unknown indication.  Case report: The consumer experienced stomach discomfort after taking Vivotif. The consumer took only two doses.  Action taken with Vivotif was dosage discontinued.  The clinical outcome of the event stomach discomfort was unknown.  Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort, after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal discomfort is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach discomfort, after the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal discomfort is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201904-000300:
I woke up at 4am to my heart racing. I am a nurse so I checked my pulse and it was 126. I tried to bear down at home to decrease my heart rate but it continued to climb to 164 so after an hour of sustained Hr 126-164 I went to the emergency room where I had SVT. They did a valsalva maneuver 3 times and that made my heart rate go down to the 130s. It was then sinus tachycardia and stayed 120s-130s until about noon. Upon discharge at 3:30pm my resting heart rate was still 105 but it was determined to be a vaccine reaction as all other tests were normal.
The injection site pain; Arm pain; There is a sensitivity; This is a spontaneous report from a contactable Nurse (patient herself) via Medical Information Team.   A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, Expiration date: unknown), via an unspecified route of administration on 29Mar2021 as, second dose single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199, Expiration date: unknown), via an unspecified route of administration on 8Mar2021 as, first dose single dose for covid-19 immunisation and experienced the event Arm pain and sensitivity at the injection. On unspecified date the patient experienced the injection site pain, there was a sensitivity and arm pain. It was reported that, Nurse calling on behalf of herself, received the first dose of the Pfizer Covid-19 vaccine on 08MAR2021 and the second dose on 29Mar2021. she reports within the last week and a half, she has been experiencing arm pain and sensitivity at the injection site. she states that she received one dose in each arm, in which both arms are experiencing pain. she states that she did not have much arm pain after the first dose, however with the second dose, she states the injection site pain went away and is now coming back, as if I just got the shot. she states that she doesn't have any heaviness in her arms and reports if she touches the injection sites, there is a sensitivity. she states the injection site pain went away after administration and now has come back. she asked if it is normal to experience this pain three months later. she states that she was really concerned about her arms. she clarified she was referring to the COVID 19 vaccine. she stated she was just called because she received the COVID vaccine shot in March and she has suddenly in the last week in a half been feeling arm pain. Caller stated she got the shots in different arms but now she having sensitivity in both sites where they put the vaccine. Caller stated she had initial arm pain, but it has not gone away, and it is June now. The outcome of the events injection site pain and arm pain was not recovered while outcome of sensitivity was unknown.   Information on the lot/ batch number has been requested
This spontaneous report was received from a physician referring to a 6-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 05-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1711USA003164: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1709USA012767:
Two days after received Pfizer COVID-19 dose #1 at vaccine clinic patient presents to US with acute, left-sided epididymitis.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number TS425) for prophylaxis.   On 25-JAN-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL (Lot# unknown). Subsequently the patient experienced weight gain. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
L arm with redness/swelling/pain from shoulder to elbow approximately 24 hrs post DTaP, IPV to L arm. Tx'd with cool compress/Motrin.
Expired vaccine receved; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine receved) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  No adverse event was reported.