chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 07-MAR-2011) concerns a 20 year old female patient. The patient had no pertinent medical history and no known allergies. The patient was pregnant at this time. Her LMP (last menstrual period) was 24-Jan-2011. Based on LMP, the estimated delivery date (EDD) is 01-Nov-2011. The patient had no previous pregnancy. On 07-Mar-2011, the patient received a flu vaccine. The patient also received her first dose of GARDASIL (batch number: 1332Y) and DtAP on the same day. No adverse effects were reported at this time. An ultrasound (baseline) performed on 06-Apr-2011 indicated the patient was at 10 weeks and 4 days pregnant. The EDC (estimated date of confinement) is 29-Oct-2011 based on ultrasound. Amniocentesis test was N/A (not applicable). MSAFP (maternal serum alpha-fetoprotein) screen was negative. There was no infection or illness during pregnancy. However she was tested positive for HPV B (hepatitis B) on 06-Apr-2011. On 02-Nov-2011, at 40 weeks from LMP, the patient delivered a live female infant (weight: 6'5 oz, Apgar score 9/9) via breech cesarean section. The infant was normal with no congenital anomaly. Follow-up (09-Aug-2011): estimated delivery date, previous pregnancy, prenatal tests, # of GARDASIL dose. Follow-up (02-Nov-2011): upgraded to serious, additional AE , pregnancy outcome.
Patient did not suffer from an adverse event.  VAERS report is completed to document administration of a dose of Janssen vaccine to a patient who was 13 years old at the time of vaccine administration.   We discovered on 5/18/2022 that we administered a dose of Janssen COVID-19 vaccine to this 13-year old patient.   Vaccine clinic was held in an outdoor "pop-up" community setting which likely led to an under-age patient being offered and receiving vaccine.   We attempted to reach this patient by telephone however were unsuccessful in our attempt.   Patient did not provide an email address.  Primary care physician is unknown.
No adverse event; the vaccine fluid leaked out at the hub with needle attached. Nothing came through the needle; This spontaneous report was received from a medical assistant referring to a 15-year-old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were reported as none. The patient's concurrent condition was not reported.  On 31-JUL-2023, while administering HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscularly for prophylaxis (lot # w026977, expiration date: 04-JAN-2025; strength and dose were not reported), the vaccine fluid leaked out at the hub with needle attached, and nothing came through the needle (device leakage). After the patient was taken care of, the same syringe and needle was used, which was filled with water, and the same thing happened. The patient was given the vaccine again with a new syringe and new needle per health care professional (HCP) instructions.
Pt developed shortness of breath and elevated BP after 10 mins after receiving 1st and 2nd dose of vaccine.  Pt developed heaving menstrual bleeding on 4/20/21 which is still persisting.
Chills, myalgias, moderately severe fatigue, mild nausea, dizziness/orthostatic dizziness
Menstruation started March 11 and lasted until March 29th and Period started again on April 6; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 10:45 (at the age of 40-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 40-years-old); both as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included unspecified birth control medication from unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient's menstruation started and lasted till  29Mar2021. On 06Apr2021, the period started again. The patient had very regular periods because of birth control and these weird periods only started after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event menstruation started on 11Mar2021 and lasted till 29Mar2021 and period started again on 06Apr2021 (menstruation irregularity) was not recovered at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient woke up at 3am to use the restroom and her legs and arms would not work. She couldn't sit or stand. She denies numbness or tingling in her limbs. She called 911 which brought her to the ED. She was given a "pain shot" because her arm hurt, and an injection for her blood pressure and diabetes. She was not treated with anything specifically for the loss of function in her limbs. Arm and leg function returned to normal around 11am.
Pt felt lightheaded. Pt did not eat breakfast or lunch prior to vaccine. Pt commonly becomes nauseated after flu shots with no additional adverse effects. Pt was positioned in supine and given Sprite and crackers. After eating, symptoms resolved.
Doses administered in pre-drawn syringes left out for over 12 hours at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered in pre-drawn syringes left out for over 12 hours at room temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered in pre-drawn syringes left out for over 12 hours at room temperature). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered in pre-drawn syringes left out for over 12 hours at room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Lips started turning white and started looking pale; Swelling of other arm (not arm where vaccine was administered), swelling of both legs; Swelling the size of a small baseball at injection site; Itching at injection site; Hot all around the injection area; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Previous COPD symptoms have been getting better since second dose.), Diabetes, Insomnia, Heart disorder, Cholesterol and Migraine. Concomitant products included ARFORMOTEROL TARTRATE (BROVANA) and ALBUTEROL [SALBUTAMOL] for COPD, ALIROCUMAB (PRALUENT) for Cholesterol, METFORMIN for Diabetes, METOPROLOL for Heart disorder, ZIPRASIDONE for Insomnia, ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) and SUMATRIPTAN for Migraine, NITROGLYCERIN, ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ESCITALOPRAM, ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PALLOR (Lips started turning white and started looking pale), SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area). On 05-May-2021, PALLOR (Lips started turning white and started looking pale) had resolved. At the time of the report, SWELLING (Swelling of other arm (not arm where vaccine was administered), swelling of both legs), VACCINATION SITE SWELLING (Swelling the size of a small baseball at injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE WARMTH (Hot all around the injection area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Liver function test: high (High) Higher levels of alkaline in liver..         Treatment information was not provided.
9:00pm on day of injection 4/2/21: body aches, chills, fever, fatigue. 4/3/21: fever broke, continued body aches and fatigue. 4/4/21 PM: body aches & fatigue gone; injection site reactions start to appear - red, swollen, warm and painful to touch 4/5/21 :  injection site reaction continue; redness is spreading - approx. 2 inches in diameter 4/6/21 :  injection site reactions continue; a blister-like lesion at site is now present (current situation at time of report)
24 hrs after shot i started feeling sick. my whole body was hot hot. I was stressed so i took something for the fever to go away. i went to bed and woke up and i was nauseous, unsteady on my feet, dizziness, Went to ER on the 10th per request from my dr that i called  and they didn't treat me. yesterday the vaccine site was very itchy. Today it slightly itchy but not bad but i feel pretty good.
ED to Hospital Admission, Discharged 8/17/2021 to 8/20/2021 (3 days) Hospital COVID-19 virus infection, weakness. Patient was admitted secondary COVID-19 pneumonia picture after presenting with shortness of breath. Patient had fatigue and tiredness with however had no loss of taste or smell. He also did have COVID-19 vaccination. Patient was placed on Decadron and supportive care and IV fluids. Patient did well and was taken off of oxygen. PT and OT evaluation was done secondary to her weakness at presentation and felt the patient would benefit from placement to ECF.
Within the first hour my upper arm went sore it lasted about an hour. Later that evening at the injection site my arm became very sore. Just lifting it up hurts. Its not a bad pain just uncomfortable. I will add to this if symptoms persists
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: he fell several times a day or two after shot. very dizzy still and weak in legs. had to get a walker to help with walking cannot stand long-Severe, Systemic: Weakness-Severe, Additional Details: was trying to get all the info from wife. she said he went to the doctor and he felt it was not because of the shot but it happened like a day after. wife is conccerned. i asked her to get a neurologist to inspect and check for any clots (ie stroke check d-dymer) and any other neurology issues like guillan barre or etc
Within 5 minutes after Moderna dose 1 vaccine patient developed tingling around the lips and tongue.   Patient has a history of anaphylaxis to Latex, and ceftriaxone.  HR 86 and regular, BP 130/80, O2 96% on room air with mask on.  After further evaluation patient c/o feeling winded like " I just finished a walk pushing the stroller." Lungs and throat sound clear.  Discussed with patient the pros and cons of administering benadryl and or epi and that would require a visit to the ED for further evaluation. Patient concerned about how the drugs will affect her breast feeding.  Through our conversation, the tingling of the lips and tongue has increased, patient is stable, decision made to wheel patient to the ED for evaluation.
I had covid and didnt know it when I got vaccinated.  I went to work and a couple days later I started feeling crappy. I had no taste and smell, very fatigued and slept all the time so I went and got tested for COVID.  While there my O2 level was 89 so I was given a steroid injection and was sent home with an antibiotic and was off for the 14 day quarantining and went back to work
Sore and swollen arm that persists, was seen today and cellulitis and abscess was diagnosed and Cephalixin and warm compresses prescribed.
Approximately 6 Hour after vaccination: Posterior Headache, lower back pain, fatigue. 12 Hours post vaccination: extreme fatigue, severe pain/swelling in joints, pain in posterior legs- bilaterally, chills , weakness,severe pain and swelling at injection site. 24 Hours post injection: Swelling in both hands with extreme joint pain, severe pain at surgical sites in hands, extreme fatigue and weakness. 60 hours post injection ; all adverse reactions resolved. Once all the above adverse reactions resolved-   the  Arthritic pain I had experienced PRIOR to this second injection has also  resolved.  I had severe  pain I both hand, left hip and ankle.  Since my severe Adverse reaction to the vaccine I no longer have this discomfort.
headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date in Jan2021 at single dose for covid-19 immunization. The patient medical history was included osteoporosis. The patient's concomitant medications were not reported. After taking the first shot patient experienced painless and little headache on an unknown date in Jan2021. Patient wanted to know if a zoledronic acid (RECLAST) infusion will interfere with the Covid vaccine. She received the first dose of the vaccine on Sunday and was scheduled to receive a zoledronic acid (RECLAST) infusion for osteoporosis today at 2:30. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
mom called reporting pt had hives from head to foot; low grade temp on & off p/receiving immun; reported hives to MD office; not seen by MD gone 29JUL93 by 8AM;
Vision got very foggy, nearly fainted, felt intensely sick to stomach, sweated profusely, couldn?t hear clearly, threw up after 20 minutes and then symptoms started to go away
my appendix went into severe spasms two days after the #2 injection. i avoid doctors especially during the pandemic, and did not go to one.  the spasms were severe for the first two days, and I am improving as long as I can get enough rest. If I have a restless night, it seems to bother me the next day, but generally, I'm seeing improvement everyday and my concern is lessened
stored Priorix in the freezer and it was exposed to -22.4 F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-month-old male patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 03-MAY-2023, the patient received Priorix. On 03-MAY-2023, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: stored Priorix in the freezer and it was exposed to -22.4 F). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-May-2023  LPN states they stored Priorix in the freezer and it was exposed to minus 22.4 F.  It was administered to a patient.  Consented to follow up via postal. The vaccine administration facility was the same as primary reporter.
Sore arm, extreme shivering, body felt like I had been hit by a truck, felt like I was going to throw up and poop my pants
Woke up two days after vaccine administration with 4 cm induration, erythema, increased localized heat, pain with decreased mobility to left arm.
Patient received the vaccine on 12/18/14 and began to develop symptoms of stiff muscles and pain beginning the next day. Symptoms progressed and became more debilitating over the next few days then began to resolve in about 2 weeks.
patient called 5/31/2019 at 12pm complaining of a feeling like she burnt the roof of her mouth.  Started one day after vaccination.  She says that there are sores on the roof of her mouth.  She is not sure if this is coincidental or related to the vaccine.
This case was reported by an other health professional via call center representative and described the occurrence of fever in a 75-year-old male patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: On 13th March 2019, the patient experienced fever of 100 F after the SHINGRIX 1st dose.
Area red, hot, raised x 4 days post injection. 9/27/99, pt states arm fine now w/no problems.
Patient c/o Rt arm pain post H1N1 vaccine dose. Patient has had "sore", "aches" on Rt arm since administration. Stated, "Hurts on and off all day". Has full ROM, pain with lifting arm at 45 degree angle, has fatigue, "hard to pick up things at times". Has taken MOTRIN po per home meds around the clock since vaccine. Denies muscle spasm/rxn at site/swelling.
The first shot I had no issues. The second shot I was tired for the next two days, no other symptoms.
Swelling to right arm with redness and warm to the touch with main of 4 on 1-10 scale. Patient states that fingers tingled yesterday. But no further tingling felt.
Patient experienced redness in the arm that the vaccine was administered in. Was treated for cellulitis while admitted for unrelated reason.
On 05/27/2022Rash manifested after 1 week of the dose 4   on my left arm then right arm.  On 06/16/2022  I went to my doctor for a regular check up. I told her that I had body aches ; fatigue;  headaches; and I also told her that I was experiencing rashes on my fore arm. she ordered blood works.  She referred me to an allergist because of the rash I had. On 06/28/2022 I was  diagnosed with  shingles . He gave me Valtrex for 7days  1 gram twice a day. It got better but It hasn't gone yet completely. On 08/18/2022 I went to the urgent care the health care person there said this is very usual. This happened right after the second booster shot. They said it might be connected to the vaccine but not sure.  They gave me a triamcinolone acetonide for 2 times a day. Its helping with the itching but it hasn't completely gone.
Patient recevied pnuemovax in right arm this morning; came back early this evening and arm was somewhat warm to the touch and swollen
When I got up in the morning things were going round and round. I knew to move slower to keep from being dizzy. Later that day when I forgot it was made as the world seemed to spin. The next day I remembered to move slower but as the day proceeded, I could not get down the hall to take something to my son. The following day I tripped over the dog bed, I had to go to the emergency room to have my ankle x-rayed, they also did a CAT scan of my head. The x-ray showed I had sprained my ankle; I was given a boot to wear. The CAT scan showed I had vertigo, and I was given meclizine to help with being dizzy. I do have a follow up visit scheduled later this month to see if I am fully recovered.
Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for two days May 28th and 29th 2021.
soreness, redness at injection site on 11/25. On 11/26 woke up to severe pain, developed fever of 101.5, and chills. On 11/27 redness and swelling spread over length of upper arm with streaks going into armpit. 11/27 afternoon went to urgent care center where they diagnosed it as cellulitis with lymphadenitis which was quickly spreading (presence of peau d'orange) treatment was iv rocephin and toradol, with oral antibiotics given for 10 days.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 53.46.  Concomitant medication information was not provided by the reporter.  Product moved to clinic on 30-Mar-2021. Vial was moved to fridge on 03-Apr-2021. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. Beyond use date for the vial was reported as 29-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
The first dose of the Moderna Covid vaccine was Injected on 01/13/2021 with no issues. On the 8th day after the first dose, the injection site on the left arm was swollen, itchy, red with a burning sensation. Employer sent me to Urgent Care about the side effect and other people in the facility had experienced similar issues. The doctor prescribed a steroid and cream. A recheck of the area will be done in two days