chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "pcos" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Dec2022 to 18Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID Vaccine Breakthrough Case   Moderna Dose 1 3/31/21 (026B21A) Moderna Dose 2 4/28/21 (002C21A) COVID Positive 11/27/21 COVID Positive 11/28/21  11/27/21: Patient is 96-year-old female with no significant past medical history presented to ED after she fell down and was complaining of left hip and back pain.  Patient endorses that was walking out of the office and had misstepped and fell down and landed on the left side of the hip and back.  Started to have some pain mainly on the left hip and back area.  Pain was 10/10 initially but improved with pain medications.   Otherwise patient denies any other site of injury.  Patient denies any chest pain palpitation.  Patient had 1 episode of vomiting of ingested material but otherwise denied any abdominal pain and is passing gas   In the emergency room labs significant for COVID-19 positive PCR, elevated blood sugar of 129, BUN/creatinine 32/1.5.  Troponin was elevated 0.07 urinalysis was positive.  Pelvic x-ray of the left hip showed moderately displaced subcapital left femoral neck fracture with distal fragment displaced proximally, moderate atherosclerotic disease and severe osteopenia  11/30/21: Patient was admitted and orthopedic surgery was consulted for a left femoral neck fracture.  She was found to be COVID-19 positive and also have a possible urinary tract infection for which she was started on ceftriaxone. She remained relatively asymptomatic from a COVID-19 infection standpoint.  She underwent left hip hemiarthroplasty on hospital day 2.  She did have some postoperative hypoxemia which improved with Acapella use. Noted to have a mild elevation troponin and echocardiogram was performed which was overall unremarkable.  Had some acute kidney injury on admission which resolved with IV fluids.  Urine culture was negative and has ceftriaxone was stopped.  She worked with PT and OT and recommended to discharge home with home health and family support.  Will discharge with COVID-19 at home program.
25 minutes after receiving Pfizer Covid vaccine #1, we had to pull off the road on the way home because he started vomiting profusely.  It was lasted a several minutes and he threw up a lot and was sweating.  He was fine no issues until after he got the vaccine.
we administer Janssen Covid-19 Vaccine , 5 to 10 minutes later the patient fainted in the waiting area. the associate who is watching our patient notified me that the patient is dizzy. I went outside and I noticed that the patient is leaning on the table and he fainted i put him down on the floor and lifted  his feet up. he woke  up in few seconds we also called 911 and they took the patient to the ER
I had an extreme headache, dizziness. My heart rate went up to 132. Yes, I promise 132! I sat on my bed just looking at it. I thought my heart was going to pound out of my chest. I had an increase heart rate for over 2 days. There were times that I literally almost went to the emergency room, but knew if I did they would take my heart rate, say it was high and discharge me home with a $3000.00 bill and tell me to drink water and rest.  I had extreme nausea and vomiting's, memory lapses and AMS. This was new, J&J didn't give me AMS.  I found myself not remembering things, I had blurry vision and was  talking nonsense  My temperature went up to 101.9 F,  I couldn't catch my breath.  I also had a localized reaction in the injection site. I ended up with an extreme head cold. On 12/29/21 I took my own Molecular C:19 test and it was negative.
18AUG92 pt recvd 1st dose of vax & w/in 24 hrs devel fever, chills & abdo cramping;
Swelling, redness, hard lump near center, itching, burning, throbbing, hot to the touch .
pt recvd vax 7OCT93 & 10 mins p/vax had a vasovagal episode characterized by turning pale, anxiety, tachycardia & passing out for 5 to 10 seconds; pt also exp blurred vision;
Arm pain (no redness or swelling); Sever armpit pain (no swelling); This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old unknown gender patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 08Apr2021(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); both from unknown date for unspecified indication. The  patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Mar2021 as a single dose for COVID-19 immunisation.  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 09Apr2021 the patient experienced Arm pain (no redness or swelling) and severe armpit pain (no swelling). 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 reported event. The clinical outcome of the event arm pain and severe armpit pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore left side of body/body aches Vomiting  Lethargic Weak Headaches Nausea Fever
Information has been received from a nurse concerning a child with asthma who on 06-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported) and a dose of DTaP (manufacturer unknown). On 06-AUG-2009 the patient experienced wheezing immediately after vaccination. The patient was administered oxygen and Benadryl as treatment. At the time of reporting the patient's outcome was unknown. Wheezing immediately after vaccination was considered to be an other important medical event by the reporter. Additional information has been requested.
Right upper abdominal pain Reflux Mid-sternal pain Pins and needles sensation in all four extremities  Numbness in hands and feet Headache-predominantly on left Ringing in ears ?Lump in throat? on left side  Inflammation under both armpits  All symptoms continue to be experienced
increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry
She said the patient is asymptomatic.; patient was accidently given 2 doses of PNEUMOVAX23.; This spontaneous report was received from a physician concerning a 79-year-old male patient. No information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history, or drug reactions/allergies was provided.  On 01-JUN-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location, lot number, and expiration date were not reported) as prophylaxis.  On 23-SEP-2020, the patient was accidentally given a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, with lot number T010293 which was confirmed as valid for pneumococcal vaccine, polyvalent (23-valent) and with expiration date reported and validated as 30-AUG-2021 (dose, route of administration, and anatomical location were not provided) for prophylaxis (extra dose administered). The reporter noted that the patient was asymptomatic (no adverse event). No product quality complaint was reported.
pt c/o severe h/a, fever, chills, arms swollen, arthralgia, & myalgias
Patient experienced dizziness, causing her to fall out of her chain and hit presumably her head or shoulder on ground.  Patient also began to vomit afterwards.
lost consciousness and fainted two times; lost consciousness and fainted two times; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 21-year-old female received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 25Mar2021 15:00 (Lot Number: 10350) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included asthma, attention deficit hyperactivity disorder (ADHD), Bipolar II and post-traumatic stress disorder (PTSD). Prior to vaccination, patient was diagnosed with COVID-19 on an unknown date. No allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE), methylphenidate hydrochloride (CONCERTA), aripiprazole (ABILIFY) and escitalopram oxalate (LEXAPRO). On 25Mar2021 15:00, the patient lost consciousness and fainted two times. Paramedics were called and she was released. The events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment was received for the events. The patient underwent lab tests and procedures which included Nasal Swab: positive on 06Jan2021. The outcome of the events was recovered in Mar2021.  The events lost consciousness and fainted occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
After the 2nd dose, I had a swollen panful lymph node on the left side of my neck for two months. About a week, I noticed increase in pain throughout my body. My joints and pain was discomfort. This pain makes my neck, back, knees and all joints are in pain. It seems to be subsiding now a little bit. But I feel this increased my arthritis pain quite a bit. The pain is more intense at night it is harder to sleep. I have more pain than I have ever had before I got the shot. Doing my activities are now more painful.
Vaccine had been in the refrigerator for 30 days and about 18 hours when the vaccine was given so it was outside the 30 day window, when stored in the refrigerator. I talked to pt the following day and she was having "normal" side effects such as feeling tired and just wanting to stay in bed. No abnormal side effects from the vaccine still 5 days later.
No adverse reaction. However On Oct. 12, stores received an internal Urgent Removal Notice regarding Pfizer COVID-19 Vaccine- Pediatric 5-11 Years Tris-sucrose, Lot #FL2757 with manufacturer?s expiration date of Sept. 30. Information has been received from the manufacturer indicating that stability data supports the use of this product through Oct. 19. For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required.
Positive erythema, positive warm to touch, swelling with slight rash (L) deltoid.
She reports that received her second dose of Shingrix series last 2/22/2022 that led to flu-like symptoms on 2/23/2022 and local injection site redness, warmth, raised bump. She describes it is the size of silver dollar. Course is stable, non-progressive. Positive associated mild productive white/pale-yellow cough, mild headache. She has underlying self-report chronic rhinosinusitis due to allergens. Her most recent COVID test three weeks ago was negative, but she was treated with antibiotics for CAP. She took one Tylenol-Allergy tablet without relief. No use of ice to area. No other sick contacts. Recently traveled to Iowa via car. She is vaccinated for SARS-CoV-2. She is not vaccinated for influenza.  1. Other Complications Following Immunization, not elsewhere classified, Initial Encounter: Patient received second dose of Shingrix series with subsequent left arm local injection site reaction complicated by flu-like symptoms. Advised that such adverse is common: Erythema at injection site (20% to 39%), pain at injection site (69% to 88%), swelling at injection site (10% to 31%). Recommend supportive care at home with acetaminophen and/or NSAID as needed, ice/cold compress to area. If no improvement, follow-up with PCP.
This spontaneous report was received from a physician via a company representative refers to a 14 year old female patient (physician's daughter). The physicians daughter fainted in the office of her unspecified treating pediatrician after having received the first shot in the GARDASIL (lot #, expiration date and route not reported) series on an unspecified date in July 2012 (last year). She received unspecified treatment for fainting. She remained dizzy for a week after having received this shot, and then she was fully recovered. It was not specified whether she sought medical attention for the dizziness. It was unspecified whether lab diagnostic tests were performed for the event. Causality was not reported. Additional information has been requested.
No adverse event; Circumstance or information capable of leading to a medication error; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 30-Nov-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to a medication error).    No concomitant products reported.  Reporter stated that she received 5 doses of Moderna COVID-19 vaccine. She received the last dose on 30 Nov 2022 Bivalent Booster at a local pharmacy. She states that her chart medical records online showed all information except the last dose had a different lot online in her chart. The Lot  on vaccination card 021H22A  NDC 80777028299. The Lot online her chart showed 021H22AS. In the website, her chart stated that the lot  belongs to 6 to 11 year age group. She stated that the pharmacy tech ensured her that she received the correct dose and even provided her with the NDC number.   No treatment products reported.
Patient had initial pregnancy test on 7/27/06 which was negative. Given smallpox vaccination on 8/4/06. Missed menstrual period on 8/4/06, took home pregnancy test and was positive. LMP 7/5/06. Pregnancy confirmed at clinic visit. 3-5 weeks gestation.
Shots were given in left arm. Arm became swollen and red with a streak of red radiating to the arm pit. Arm was very soar to the touch and hurt when moved.
Child was given adult doseage of Hep A Vaccine and was supposed to receive pediatric doseage. No adverse effect from vaccine.
face pain; muscle spasms in neck; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (face pain) and MUSCLE SPASMS (muscle spasms in neck) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced FACIAL PAIN (face pain) and MUSCLE SPASMS (muscle spasms in neck). At the time of the report, FACIAL PAIN (face pain) and MUSCLE SPASMS (muscle spasms in neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  Treatment information was not reported.
This retrospective pregnancy case was reported in a literature article and described the occurrence of laryngomalacia in a neonate. The mother received Flu Seasonal QIV Dresden. The pregnancy resulted in a live neonate with a congenital anomaly. The neonate was diagnosed with laryngomalacia. Serious criteria included GSK medically significant, congenital anomaly and other: serious per reporter. Additional event(s) included maternal vaccine exposure and live birth. The outcome of laryngomalacia was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown) and live birth (unknown). The investigator considered that there was a reasonable possibility that the laryngomalacia may have been caused by Flu Seasonal QIV Dresden. Additional information was provided. This retrospective pregnancy case was reported in this literature article and described the occurrence of laryngomalacia in a neonate of unspecified gender whose mother was vaccinated with unspecified seasonal inactivated influenza vaccine (manufacturer unknown) during pregnancy. The patient's mother was a part of the study that assessed the safety of seasonal inactivated influenza vaccines (IIV) and live attenuated influenza vaccines (LAIVs) in pregnant women and their infants whose reports were submitted to Vaccine Adverse Event Reporting System (VAERS) during 2010-2016. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient's mother received unspecified seasonal inactivated influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). Subsequently, the patient was exposed to the vaccine in utero. On an unspecified date between 1 July 2010 and 6 May 2016, an unknown period after maternal vaccine exposure, the patient developed laryngomalacia. This case has been considered serious as per the authors. Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between laryngomalacia and unspecified seasonal inactivated influenza vaccine. However the authors stated, "VAERS also generally cannot determine whether a vaccine caused an AE." The authors concluded that "During the study period 2010-2016, the average annual number of VAERS reports following IIV in pregnancy decreased compared with the 2009-2010 pandemic period but remained higher than prior to the pandemic. Similar to the 2009-2010 period, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. Maternal influenza vaccination benefits both the mother and the infant, protecting both from influenza disease. Given that the antigenic composition of these vaccines usually changes each season, the CDC and FDA will continue to monitor the safety of influenza vaccines in pregnant women." This is 1 of the 12 valid cases reported in the same literature article.
Generalized tonic-clonic seizure lasting less than one minute. No fever, but nasal congestion and coughing started about 48 hours after the flu vaccine was administered.
Instant pain in arm, extreme pain in arm for 1 week. 2 weeks later & still getting arm pain when arm is held above heart level
On 1/5/00, the pt experienced chickenpox. There were 72 pos throughout the body. The pox were not very large or pus-filled. They were mildly itchy. She also had a low-grade fever. On 1/10/00, the pt recovered from chickenpox.
Information has been received from a physician concerning a school age patient who was vaccinated with a dose of varicella virus vaccine live. "Last week", in February 2006, the patient experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a physician concerning a school age patient who was vaccinated with a dose of VARIVAX (Merck). "Last week", in February 2006, the patient experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved.No other information was provided. Follow-up information indicated that no patient was actually involved in the previously reported experience. Therefore, WAES # 0603USA02492 is being deleted from our files on VARIVAX (Merck).
Left bicep turned very red and tender, about 3 to 4 inches from injection site. Put benadryl cream on area and taking acetaminophen 500mg.
Swollen, tenderness, discoloration around eyes. I applied ice, but did not help.
Systemic: Burning sensation-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt felt light headed and a burning sensation for 4 minutes. Ice pack and juice were provided, pt felt okay after 10 mins
Overnight had sore arm, chills, sweating, low grade fever. All the next day all muscles and joints ached, fatigue, headache. Initiated an hsv2 outbreak.
Vaccine administered 10/15/12. Patient appeared at pharmacy 10/18/12 to ask about redness at injection site and stiff neck. I advised patient to seek medical attention. 10/19/12 Called patient for follow-up. Dr. prescribed AUGMENTIN and CLARITIN.