chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist received via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received PNEUMOVAX 23 for immunisation. About one year before the patient experienced swelling on arm on an unspecified date with outcome of unknown. Information about batch number cannot be obtained.
sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Apr2021 16:00 (Lot number: EW0170) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: reported as Mild asthma, which grew out of when patient was 11 or 12. Otherwise, no health issues.; "Sulfa (medication) allergy" (ongoing), notes: known allergies: Sulfa (medication); "Saffron allergy" (ongoing), notes: known allergies: Saffron; "Cashews and Pistachios allergy" (ongoing), notes: known allergies: Cashews, Pistachios. Concomitant medication(s) included: BENADRYL; CANNABIS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore right arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient prior to the vaccination was not diagnosed with Covid-19 and since the vaccination, he had not been tested for Covid-19. The patient didn't received any other vaccines within four weeks prior to the vaccination. Reported that side effects from first shot were not bad at all. Just sore right arm for 2 days.   No follow-up attempts are possible. No further information is expected.
EXPERIENCED SIDE EFFECTS AFTER GETTING THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced experienced side effects after getting the vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of experienced side effects after getting the vaccine was not reported. This report was non-serious.
Initial and follow up information has been received from a 14 year old female for the Pregnancy Registry for GARDASIL with an allergy to KEFLEX who on 27-DEC-2006 was vaccinated with a first dose of GARDASIL 0.5 ml IM.  Subsequently she received the second dose of vaccine and on 27-SEP-2007 received the third dose of GARDASIL.  Concomitant medication included vitamins (PNV).  The patient's last menstrual period was 7 weeks ago (approximately 13-AUG-2007).  She sought medical attention.  On 29-SEP-2007, she found out that she was pregnant.  A pregnancy test was performed.  At the time of reporting, she had not experienced any adverse reactions.  The estimated date of delivery is 19-MAY-2008.  Follow-up information was received, concerning a 14 year old female patient with no previous medical history reported.  On 18-MAY-2008, the patient delivered a normal, healthy female baby weighing 7-9 lbs, length 21, Apgar score 8/9 and head circumference 14.5.  No complication during pregnancy, labor/delivery, infections or illness during pregnancy were reported.  On 23-MAY-2008 the baby had a 5 day well child visit and was doing well.  Weight was 7.45 pounds.  Bilirubin was 10.8 mg/dL.  On 02-JUN-2008 a newborn screening for congenital hypothyroidism, congenital adrenal hyperplasia, hemoglobinopathy, galactosemia, fatty acid disorders, organic acid disorders, amino acid disorders and cystic fibrosis were all normal.  On 21-JUL-2008 a 2-3 month old well child visit was performed and the baby was doing well.  Her parents reported some nasal congestion and constipation.  Otherwise she has a bowel movement every 24 hours.  The outcome of the congestion and constipation were not reported.  No additional information is expected.
Redness/warmth R. thigh in area of varicella vaccine --> no treatment necessary.
SEVERAL HOURS AFTER RECEIVING THE VACCINE PATIENT WAS ATTENDING A POOL PARTY WHEN HE STARTED TO HAVING CHILLS ALL THROUGHOUT HIS BODY THAT LASTED ABOUT 4-5 HOURS WHICH RESULTED IN A MILD FEVER LASTING ABOUT 2-3 HOURS AFTER. HE RETURNED HOME TO REST AND WOKE UP THE NEXT MORNING WITH EXTREME SENSITIVITY TO HIS SKIN THROUGHOUT HIS WHOLE BODY. HE STATES IS WAS VERY PAINFUL TO THE TOUCH. THESE SYMPTOMS IMPROVED AND HE FELT FULLY RECOVERED AFTER THE SECOND DAY. HE STATES THERE WERE SOME SORENESS IN THE ARM AT THE INJECTION SITE BUT FELT IT WAS SIMILAR TO THE PREVIOUS DOSE HE RECEIVED A FEW MONTHS PRIOR.
Achiness; Tiredness; Slight soreness in my upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to metals and Diabetes since 01-Aug-2019. Concomitant products included METFORMIN from 01-Aug-2019 to an unknown date, GLIPIZIDE from 15-Aug-2019 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 07-Jan-2021 to an unknown date for Diabetes.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Slight soreness in my upper left arm), PAIN (Achiness) and FATIGUE (Tiredness) had resolved. Not Provided          Treatment information was not provided by the reporter.  other concomitant medications included centrum silver multi-vitamin from 01-jan-2016 and still ongoing,  it was used for general health purpose and taken orally 1 per day and Ester-c vitamin was taken from 01-jan-2003 and still ongoing, it was used for Immune system health  and taken orally 500mg/1 per day.   This case was linked to MOD-2021-056082 (Patient Link).
Fever 100.4, headache, body ache. Took ADVIL and TYLENOL, lasted about 24 hours.
Slight fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Slight fever) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (Chills) had resolved.            The concomitant medications were not provided. The treatment information was not provided. The action taken for mRNA-1273 with the events was considered as not applicable.   This case was linked to MOD21-061320 (Patient Link).
Case number PHEH2014US02020239 is an initial spontaneous report received from a health care professional (also patient) on 01 Oct 2014. This report refers to an adult female patient of unknown age. Her medical history and concomitant medications were not reported. Her vaccination history included administration of other vaccines such as tetanus booster (unknown manufacturer, batch number: not reported) on unknown date and was well tolerated. She also received FLUVIRIN (batch number: not reported) intramuscularly in the past (unknown number of doses) and experienced events (see related case numbers: PHEH2014US020232, PHEH2014US020234, PHEH2014US020235, PHEH2014US020236, PHEH2014US020237, PHEH2014US020238). She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on unspecified date. It was reported that on an unknown date after vaccination, her arm was swollen, red and hot. The outcome, seriousness and causality of the event were not reported. She was also vaccinated with FLUVIRIN (batch number: not reported) on unspecified date in next year and experienced similar events (see related case number: PHEH2014US020240).
pt recvd vax & 1wk following vax pt devel a fever of 102; med hx included fever of 102 following each of 4 doses of DTP; No further details were provided;
Shingles outbreak on left arm from shoulder to wrist.  Began 17 days after 2nd dose of vaccine.  Rash with pustules.
Pt arm began turning red below the vaccination site and the right arm began turning red as well. Patient complained of feeling warm and was given diphenhydramine liquid 50mg .Began complaining of itching in ears and throat. After approximately fifteen minutes after taking the medication she started feeling better. Remained in the store approximately 45 min to and hour after receiving the vaccine. She left with husband and children feeling better.
administered an expired Twinrix vaccine.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: Nurse reported that the patient was administered an expired Twinrix vaccine, which led to expired vaccine used. The reporter consented to follow-up.
vaccination site warmth; vaccination site etching; vaccination site pain; vaccination site redness; vaccination site prickly-looking rash; a swollen knot the size of the palm of her hand at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site), VACCINATION SITE PAIN (vaccination site pain) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site). On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash). The patient was treated with MELOXICAM for Pain, at an unspecified dose and frequency. On 10-Apr-2021, VACCINATION SITE SWELLING (a swollen knot the size of the palm of her hand at vaccination site) had resolved. At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site etching), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE RASH (vaccination site prickly-looking rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
diagnosed with Covid on 11Mar2021; Tenderness in area around injection site; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration on her right arm on 03Mar2021 as single dose for COVID-19 immunization. The patient's medical history included myelodysplastic syndrome (MDS), bone marrow transplant, low thyroid, hyperparathyroidism, oral and ocular graft versus host disease (GVHD). On 03Mar2021 at 17:00, the patient experienced tenderness in area around injection site. The patient reported with symptoms of COVID (irritated throat, stuffy nose, sneezing) on 11Mar2021. The patient was diagnosed with COVID on 11Mar2021 via PCR nasal swab. The patient went in for testing and was negative on 12Mar2021 via PCR nasal swab. However, the symptoms progressed to include low grade fever and worse fatigue so the patient was rested on 15Mar2021. The patient was tested positive for COVID via PCR nasal swab on 15Mar2021. The outcome of the events was recovering.
Esophageal/chest spasms, hives. Have developed a hypersensitivity to various foods. These foods have become triggers for these spasms and hives. This have been going on for over 3 months. Food sensitivity is random. I have to maintain a very restricted and limited diet to avoid these episodes. The spasm episodes last anywhere between 2 to 12 hours. Problem foods include: berries, soy, coconut, beef, seeds, garlic, onions, most spices and seasonings, wheat, and many more. I can eat chicken,turkey, salmon, rice, most vegetables, oatmeal, apples, nectarines, peaches, avocados, gluten free bread.
Redness at injection site; Stomach Cramping; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and stomach cramps. On an unknown date, the outcome of the injection site erythema and stomach cramps were recovering/resolving.   It was unknown if the reporter considered the injection site erythema and stomach cramps to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine and experienced redness at the injection site that was beginning to fade 3 days following vaccination. The patient also reports stomach cramping. The reporter did not consent to follow-up. The reporter provided limited information and did not want to proceed with providing further details including date of birth, consent, pharmacy information, or details about side effects.  The reporter mentioned she may contact back if desired. The reporter enquired how long redness and stomach cramping would last.
Immediate severe pain to injection area as well as left shoulder joint. Pain increasing over next 5 days despite Tylenol. Range of motion reduced to 20% of normal. Pain and loss of motion continue to worsen. Injection site was very high up on deltoid.
Patient's caregiver brought patient in to receive a COVID-19 Pfizer vaccine on 09/13/2021.  The patient?s parent filled out a consent form on behalf of the patient and listed the date of birth as 02/01/2009 and signed and consented on the official  Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s mother.  Metro Public Health guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions. Upon entering the vaccine into the Tennessee Immunization Information System (TennIIS) it was discovered that the patient's true DOB was 02/01/2010  and therefore this was an unauthorized vaccination.  The date of birth was then confirmed and verified in the regulatory authority  The regulatory authority was notified.  In addition, the patient's mother and father were notified per protocol.  Weeks later the patient's mother attempted to bring all three of her 11 year old triplets to an event to get the second dose although she had been informed we would not be giving a dose until it was approved for an 11 year old.  The mother stated that the children were 12 and that the Patient's mother brought patient in to receive a COVID-19 Pfizer vaccine on 08/28/2021.  The patient?s mother filled out a consent form on behalf of the patient and listed the date of birth as 07/22/2009 and signed and consented on the official regulatory authority Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s mother.  Regulatory authority guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions. Upon entering the vaccine into the regulatory authority it was discovered that the patient's true DOB was 07/22/2010  and therefore this was an unauthorized vaccination.  The date of birth was then confirmed and verified in the regulatory authority.  The regulatory authority was notified.  In addition, the patient returned with his mother and 2 sisters to try to get a second dose although the parents had been informed that we would not be giving a vaccine to any child under 12 years of age until approved to do so. The patient did not receive a second dose from our team that day.
He developed GI reflux, spitting up, and pain prior to 2 month check-up. However, following 2 month immunizations, became much worse with green diarrhea, vomiting, and inconsolable crying. Lasted for several weeks, eventually improved at 3 months with maternal elimination diet for 2-3 weeks prior to 4-month check-up, GERD, green diarrhea, and vomiting had resolved. See in office for 4 month immunizations 8/24/18, that night again developed GERD, spitting, green diarrhea, and severe fussiness. Symptoms seem to be improving 4-5 days after vaccines.
Person describes having a headache. Denies any other complaints. Pt has hx MS. Pt did not take BP meds this am. Pt says she gets nervous before shots. BP 152/97 O2 %100 72 bpm
Received FLUZONE 2009-10 multivia -L SA- injection 11/23 in left shoulder at pharmacy adverse effects began Tuesday am 24th, right hip joint pain, resembled pinched nerve. Later same day noticed weak muscles in both legs, right weaker than left, and dizziness. Difficulty in sleeping, pain in right leg, both thigh and shin. Some pain in left leg too but not as bad. Unable to stand up due to muscle weakness, had to crawl to bathroom on hands and knees. Difficult to find a comfortable position for sleeping. More frequent urination than usual, body is trying to get rid of the poison. Pain continues intermittently, abates when I lie down on my back on a soft sofa and tell my pulse rate to relax. What kind of snake venom are they putting in this stuff?
patient was with family to get covid vaccine. family made appointments online for all 3 members ). Family reported she was 18 years old. After going over questions with all 3 members I gave them each their vaccine on Friday 4/16/2022 without incident.  Monday staff got call from  district leader asking about the patient because when her vaccine info got loaded into MIIC it showed that her 17 and not 18 as we were told at pharmacy so she could get a shot.  Staff pharmacist called monday 4/19 and left voice mail for patient to contact us, and we called again wednesday 4/21, but we have not had call back from patient as of thursday 4/22/21.  I do believe pharmacy was intentionally mislead about her age so she could get vaccine with mom and dad, and I believe no one is calling us back because perhaps they realize we found out, per MIIC, that she is not 18 years old. I cannot confirm that is exactly what happened because no one is answering phone or calling us back, but I felt it still important to do VAERS report in timely manner.
Client came to Covid-19 clinic for 2nd dose of vaccine.  Described the following to the RN administering vaccine.  Client stated she had a rash and "itchiness" at injection site and going down her arm after her first dose.  Second dose deferred at this time.   Encouraged client to report reaction to primary care provider for guidance on receiving the 2nd dose of the vaccine series.
pt recvd vax 13OCT95 & was well until 16OCT95 when devel cough, hoarseness, loose stools then had 3 episodes of apnea w/blue color & jerky movements; seen in ER then sent home;episodes repeated went to another ER was +postictal; szs cont
Possible SIRVA?  Patient left message on nurse line: got her covid vaccine on 7/19/2021- continues to have a stabbing pain in her arm where she received the vaccine - patient seeking advice on treating pain.   Nurse spoke with pt, states she received her covid vaccine on 7/19 in her right arm. Since then she has been having intermittent stabbing sensation to her arm in the area that she received the shot. States it comes and goes, will sometimes bring her to tears, visually nothing is different about arm, and no weakness, tingling, numbness ect.  Patient is a 56 y.o. female presenting with 2 weeks of right deltoid pain which developed after getting her 1st COVID vaccine.  She describes a sharp stabbing sensation in her right shoulder, with pain that sometimes does radiate down her right arm.  Symptoms have not improved over the past 2 weeks.  Denies any significant weakness in her upper extremity.  She has tried ibuprofen, Tylenol, Norco, which has not helped at all with the pain.  She does take gabapentin 300 mg which she does feel has helped somewhat.  No discoloration of the skin.  No fevers, no chills.  Assessment / Plan: 1. Pain of right upper extremity - US EXTREMITY SOFT TISSUE UPPER RIGHT; Future - predniSONE (DELTASONE) 20 MG tablet; Take 1 tablet by mouth 2 times daily for 5 days.  Dispense: 10 tablet; Refill: 0 - methylPREDNISolone acetate (DEPO-Medrol) 40 MG/ML injection 40 mg  1. Depo shot given in office, also recommending 5 day course of prednisone.  Will get ultrasound to evaluate right upper extremity.  Suspicion for hematoma which may be causing her symptoms.
Moderate pain at injection site and muscle aches.  Mild nausea, fever and chills
Had syncope, possible seizure 4 days after HPV9 vaccine. Patient was in a choir performance and complained of not feeling well. Patient started to turn blue and have trouble breathing. Patient's eyes were rolling in back of head. She was shaking a bit. EMT notified but patient refused to go to ER.