chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Team member came to medical for his second dose of the Moderna COVID vaccine. Team member was vaccinated and when the RN went to update his card the team member told her he had not received a card and thought he would get one when he finished the series.  The RN immediately checked the records to find he had been vaccinated the previous week with his first dose. Team member was not properly educated and was under the impression he only had a 1 week wait period between doses. He was also not provided with a vaccine card from whomever vaccinated his the first time.
Dry cough, headache, intermittent nausea and diarrhea, head congestion, upset stomach, chills, fever 101.7 to 102. All symptoms lasted 8 hours.
No further adverse events; HCP reporting administered dose of expired PEDVAX HIB.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug allergies or reactions, concurrent conditions, and concomitant therapies were not reported.  On 06-APR-2022, the patient was vaccinated with an expired haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), 1 dose, lot number S030964, expiration date reported and validated as 01-APR-2022, (strength, vaccination schedule, anatomical location of injection, and route of administration were not provided) for prophylaxis (expired product administered). It was stated that no history of prior excursions on products, no further adverse events were reported/ no product quality complaints.
Pt was not old enough to receive 4th pfizer shot ** 2nd booster**
Redness on Left Upper thigh in region of MMRV vaccine; did not appear until 6 days after vaccination per mom. No spreading of erythema. Focal. Non tender.
Itching skin, red patches on skin and welts, especially chest, back, arms and face
Patient reports feeling dizzy and looks pale. Vital signs are taken at 1:30 pm B/P 100/60 68/ min, respiration 16, and dxt. 87mg/dl. Dr. is consulted and indicates the patient legs to be raised and the vitals are re-evaluated in the next 30 min. The new vital signs are taken spo2 99%, BP 100/80, pulse 82/min. Patient is discharge and walks out of the vaccination center.
convuls that lasted approx 3 mins; made high pitch sound prior to vax became cyanotic was confused 30 mins p/convuls; had no fever, no dampness to skin, did not vomit;
Severe muscle pain, radiating down arm to fingers, and up arm into neck, down left leg, range of motion in left arm very limited.
Patient received Menactra first in R arm without issue. Hep A was given in L arm and patient passed out and fell off of exam table and stated that it "made me feel really weird".  He was checked out by provider after incident.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
A few hours after the vaccination the patient started getting some severe muscle spasms making it hard to sleep. The next day she took ibuprofen and Benadryl and it seemed to help a little but she has still getting spasms off and on through today 04/10/21. The spasms have lessened in frequency and severity. She does not think she needs to go to the ER, but she may call her health care clinic Monday if she is still having the spams
On day 3 I woke up with chest tightness which progressed to slight chest pain. By day four it progressed worse and something felt like it squeezed my heart, first visit to the ER, all tests normal. Day 5 chest tightness became worse and slight pains again. Day 6 when I went to sleep I woke up with heart palpitations and pounding and chills and tremors. I checked back into a different ER (the heart hospital), all tests again are normal but I experienced multiple episodes again while there. Believed to be having panic attacks. I have improved by avoiding all triggers but chest is sore and slightly painful still, somewhat tight.
liver pain; kidney pain; confusion; severe agitation; foul smelling; explosive diarrhea; malaise; intestinal distress; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.  A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number EW0196), via an unspecified route of administration, in Left arm on 07Jul2021 02:00 PM (at the age of 49-years) as DOSE 1, SINGLE for covid-19 immunization. Patient had medical history of bilaterial (left and right) total hip replacement from an unknown date and unknown if ongoing. The patient previously received mucinex and experienced drug hypersensitivity. Concomitant medications included ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (SUPER B COMPLEX [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lisinopril (LISINOPRIL) all taken for an unspecified indication, start and stop date were not reported. Patient had not received any other vaccine in four weeks. Patient not had COVID prior vaccination and was not tested COVID post vaccination. On 08Jul2021, the patient experienced Liver pain, kidney pain, confusion, severe agitation, foul smelling explosive diarrhea, malaise, intestinal distress. Events considered as non-serious as per the reporter. Patient had not received any treatment for the events reported. Outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
BLOOD CLOT NEAR LIVER; This spontaneous report received from a consumer via other manufacturer (Abbvie) concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot near liver and was hospitalized (date unspecified). This happened after covid shot. Number of days of hospitalization was unknown. Patient agreed to have MD contacted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from blood clot near liver. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221022007-COVID-19 VACCINE AD26.COV2.S- Blood Clot near liver. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Three days after receiving ROTARIX vaccine patient began having gassiness, fussiness and abdominal pain. A day later, he also began having bloody stool. He was thought to have milk protein allergy and was sent home. Later that night, 4 days after vaccination, patient also began refusing food. Seven days after vaccine he developed fever and bilious emesis in addition to persistence of preceding symptoms. He was found at that time to have intussusception. Reduction of intussusception failed twice. During attempt to reduce with air, the bowel was perforated. Ex-lap was performed and patient underwent subtotal colectomy, partial ilial resection and end ileostomy on 5/24. He required parenteral nutrition for approximately two weeks, was transitioned to NG tube feeds and ultimately oral feeds. He required blood transfusion of 1 unit pRBCs on 5/29.
09/16/22 presents to ED for "abdominal pain". PMHx of "enteritis"
Within 1 month of my second shot, my feet and ankles became swollen.  I had a scan of the veins in both legs which revealed no issues. All of my recent lab work has been normal including my kidney function despite having a transplanted kidney (11/2014). The swelling has been constant since April 2021 (4 months).
The patient became very dizzy upon standing and the dizziness continued for approximately 45 minutes. Vitals taken at 1150=BP=138/85, P=106, O2=98%,  1215 vitals= P=72, O2=96%. Patient provided water and snack as the patient states she did not eat prior to coming in for vaccine. Patient able to ambulate out of area on own and states she felt better.
We were very careful and avoided all kinds of contact indoors and wore masks for a while. After the 5th vaccine, I felt good about things, we let out guard down for one evening. We went out socially and it was New Years Eve. We believe that a band member at this event may have been the person infected first. I didn't know and no one really knew. Since having allergies, symptoms were usual. But I had more sneezing than usual. I came home in the afternoon the day after, and I felt like I had more drainage and more sneezing. I took my temperature and it was elevated around the 99s. I took a COVID-19 test at home and it was mildly faint and I assumed it was positive. I found out more about Paxlovid and talked to the triage nurse and made a telehealth visit that was scheduled for two days later. I waited for my appointment on 01/05. I was more tired the next day and ran a fever. I rested in bed all day and just felt tired all day. The temperature went up to 103 at the highest. I felt normal, just tired, elevated pulse and blood pressure. That subsided at that point and i felt better. When I had my telehealth visit, I told her all the symptoms. At that point, she suggested Paxlovid would be a good treatment and I would have it on hand just in case things got worse. My research found that I had a risk of long COVID, so I thought to take the antiviral and reduce the chance. I started the dose on 01/05. Nirmatrelvir and ritonavir 300mg of the first and 100mg of the 2nd. I would take 3 tablets twice daily 5 days, 10 doses all together. I tried to stay exactly 12 hours apart on all those doses. From the notes from doctor: it was noted mild cold symptoms, scratchy throat, drainage. Thought it was allergies, but noticed worsening fatigue, raspy cough. Positive for COVID-19. General notes of quarantine  and instructions for Paxlovid, rest and fluids etc. I did lose 3-4 pounds and my temperature went below 103. My fever went down to 100 over the next few days and went back to normal within that same week. I noticed I had some higher blood pressure and pulse after Paxlovid, but that resolved over a few weeks. My wife also had possibly had COVID-19 and was given Paxlovid. She had a rebound case and the doctor noted that may have been dry particles when doing the test. By 02/01/2023, I noted I was fully recovered. I was also part of a study for monitoring antibodies. I reached out to my doctor to test the S antibodies and they were boosted which meant my body was prepared for the infection.  12/31/2022 - Date of exposure around 08:00PM 01/03/2023 - Symptoms became stronger than usual allergy symptoms 04:00PM 01/04/2023 - Symptoms began to get worse 01/05/2023 - Felt better, had telehealth visit, temperature at the time was 101.4. Started taking Paxlovid that evening 09:00PM
no adverse event; she accidently administered both VARIVAX and PROQUAD to a patient instead of VARIVAX and MMRII.; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 21-NOV-2022, it was reported that a patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 milliliter (ml)/once, lot #W023866, expiration date: 24-JAN-2024 (strength, anatomical site injection were not provided), and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, both vaccines administered subcutaneously for prophylaxis (strength, anatomical site injection, lot #, and expiry date were not provided); instead of varicella virus vaccine live (oka/merck) (VARIVAX) and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). (wrong product administered). No adverse event was reported.
fever of 100; intense pain in the upper arms, both arms, with intense shoulder and upper arm pain; intense shoulder and upper arm pain; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On 17th April 2020, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, pain in arm and shoulder pain. On an unknown date, the outcome of the fever, pain in arm and shoulder pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient and her family did not have any medical history. The patient received the dose of Shingrix might be in her left arm and experienced fever of 100 degree F and intense pain in the upper arms, both arms, with intense shoulder and upper arm pain. On 21st March 2021 the patient received the dose of Covid-19 vaccine and 9 days after the vaccination on 30th March 2021 patient experienced Itching at vaccination site, swelling the size of a chicken or goose egg and also injection site was warm and red. The reporter consented to follow up.
sx 12-19-22    admitted at MED CENTER 1-2-23 ; expired on 1-27-23 He had ho heart TX/MDS/chronic immunospressants was admitted with multifocal pneumonia, covid pneumonia, resp failure.  intubated 1-15-23   Complicated course  developed ARDS,    renal failure did not tolerate crrt.   septic shock with vasopressors.   chronic pancytopenia and h/o ITP.   It was decided to give him comfort measures .
A mother reported that her 5 year old daughter received an injection of Tetramune and was subsequently treated for mercury intoxication. The mother also reported that her daughter has neurological sequelae. The mother attributed these events to thimerosal. This event is considered medically important.
Customer is not sure if an adult patient received PEDVAX HIB; Circumstance or information capable of leading to medication error; No other AE.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (exact dose, route of administration and anatomical location were not provided) for prophylaxis, therefore experienced product administered to patient of inappropriate age. No adverse event was provided.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a hospital, as recommended for routine adult health maintenance and the intended purpose for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On an unknown date in 2016, the patient was treated by a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I have developed tinnitus and am experiencing hearing loss. It is sometimes very intense and sometimes mild but 2 months out still a problem.
Consistent headache; Nausea (carsick type nausea, gaggy, not stomach); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 at 12:15 (at the age of 30-years old) as a single dose for COVID-19 immunisation. The patient did not have any other relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 19:00, the patient experienced consistent headache and nausea (carsick type nausea, gaggy, not stomach) for last 3 weeks. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in a visit to the doctors or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events, consistent headache and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Redness, swelling and itching about 2 inches lower than injection site, itchy eyes, along with severe chills, stomach pain, muscle aches (entire body), headache
Fever and high pitched crying began the evening following vaccines. Temp up to 101-102. Fits of crying intermittently 2-3 days. Loss of appetite, lasting at least 4 days.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016) intramuscular. The patient was vaccinated with an expired vaccine. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Within a minute pt became flush and faint. Then his arms tensed, his eyes rolled and he drooled, this lasted approx 30 seconds and was followed by a 10-20 min after ictal state (sleep and diaphoresis). Sugar soda was given, Blood sugar later recorded at 93, BP at 82/58 by nurse, 86/60 by DR.
Pt called to ask why her arm hurt so badly. She is not able to lift her arm. Advised to continue ALEVE (which she started when it began hurting) if not improved by Monday to visit to PCP f/u 1/22/18. Pt states better but not completely gone.
Patient brought to the emergency department by EMS on 6/1 for shortness of breath, cough, and chest pain. Found to be Covid positive via PCR testing in the emergency department, was admitted from 6/1-6-5. He initially required BIPAP, however was able to wean off. This meets criteria for vaccine breakthrough case review.
The patient did not report any adverse events after being vaccinated.; The patient received an improperly stored vaccine M-M-R on unspecified date between 18-MAR-2020 to 24-MAR-2020.; This spontaneous report has been received from a physician, regarding to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On an unspecified day in March 2020 (also reported as "between 18-MAR-2020 and 24-MAR-2020"), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneously (SC) as prophylaxis (dose, frequency and expiration date were not reported); the lot number S027461 was an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live. In addition, the physician stated that it was determined from the stability data, that the suspect vaccine was stable, and that the patient did not report any adverse events after being vaccinated. Additional information was not expected.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA006671: US-009507513-2003USA009717: US-009507513-2004USA001737: US-009507513-2004USA001738: US-009507513-2004USA001740:
Throat closure, tongue swelling, body aches, chest pain, SOB, coughing, congestion, elevated bpm,
The pt was very sleepy X 10 hours, post vax. She slept through diaper changes and feedings.
LOCAL INFLAMMATORY REACTION TO (R) DELTOID. APROX 2" CIRCLE.
Maculopapular rash on cheeks, chin, chest, abdomen, few on upper thighs 10 days following below immunizations;
I had filler under my eyes, injected in mid-December 2020.  After Pfizer vaccine 2  my under eye area puffed up where the filler was placed and has remained puffed up now,   25 days after the 2nd shot.  No signs of resolving.  Has remained as it was on February 5th 2021 no change.  Not good.