chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraines; first shot of the Pfizer Covid 19 vaccine and got the moderna shot for her second shot; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MIGRAINE (migraines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Pfizer Covid 19 vaccine and got the moderna shot for her second shot) and HEADACHE (Headache) in an 82-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Pfizer Covid 19 vaccine and got the moderna shot for her second shot) and HEADACHE (Headache). At the time of the report, MIGRAINE (migraines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot of the Pfizer Covid 19 vaccine and got the moderna shot for her second shot) and HEADACHE (Headache) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Heavy pressure on my chest with shortness of breath. Acid reflux, headache, body pain
HCP called to report that a dose of VARIVAX was given on 11/16/2023, to a 2-month and 7-day old male patient. HCP reports no signs or symptoms are present in the patient, and that the patient is no longer in the office. HCP gives permission to contac; HCP called to report that a dose of VARIVAX was given on 11/16/2023, to a 2-month and 7-day old male patient. HCP reports no signs or symptoms are present in the patient, and that the patient is no longer in the office. HCP gives permission to contac; This spontaneous report was received from a nurse referring to a 2-month-old male patient.   The patient's medical history and current conditions were not reported.   On 16-NOV-2023, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/once, lot #X017487 (lot verified), expiration date: 25-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). On the same date, pneumococcal vaccine conj 7v (CRM197) (PREVNAR) (formulation, strength, dose, lot #, expiry date, and route of administration were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (formulation, strength, dose, lot #, expiry date, and route of administration were not reported) were also given to the patient. No signs or symptoms were reported in the patient at the moment of the visit at the office (No adverse event).   At the time of reporting, the outcome of the events was unknown.
The patient reported the day after receiving her immunizations her right arm developed swelling, redness, pain and was warm to the touch; pt reported being in bed for 3 days feeling ill, her PCP prescribed Cephalexin 500mg capsules to take twice daily for 10 days, she came yesterday 04/21/23 to the pharmacy and informed us and she was feeling better and her arm had improved.
Intense pain in neck and arms; Intense pain in neck and arms; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Concomitant medications received within two weeks of vaccination were not reported. The patient previously took azithromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. The patient previously also took doxycycline (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. 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 22Apr2021 at 19:00, the patient experienced intense pain in neck and arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events intense pain in neck and arms was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Edema of hands, feet, eyes with mild urticaria within 12 hrs of injection.
Pfizer-BioNTech COVID-19 Vaccine EUA - admitted to hospital 04/5/2021with covid-19 after one dose of Pfizer Covid-19 vaccine on 3/18/2021. 79 yo Female received 1st dose of Pfizer Covid-19 vaccine on 3/28/2021.  Reactions reported were body aches and soreness at the injection site shortly after vaccine injection.  After vaccination, patient found out that 2 of her family members that she lives with had positive Covid-19 tests (health status of these family members unknown).  Patient got a covid-19 test on 3/30/21 and it was positive.  On 4/2/2021, pt had a telemedicine visit for fever and dry cough.  Azithromycin and albuterol prescriptions were given because of concern
Information has been received from a consumer mother concerning her daughter with no pertinent medical history and no known drug allergies who in 2008 was vaccinated with the third dose of GARDASIL (lot# not provided). There was no concomitant medication. Mother stated that she noticed after her daughter's third dose of GARDASIL, her daughter's cuts would bubble up when healing. The scars were more like lesions a quarter inch thick raised off the skin. Patient sought unspecified medical attention. No lab/diagnostic studies performed. At the time of this report patient had not yet recovered. Additional information has been requested.
Pt given KINRIX (DTAP/IPV) at 2 mo of age. Pt's mother reports no adverse effects.
Information has been received from a consumer concerning a 5 year old male patient with no drug allergies or medical history, who in August 2009, was vaccinated with a dose of MMR II. There was no concomitant medication. Subsequently the patient developed measles after receiving MMR II. The patient developed fever of 100.5 degrees F and then rash all over his body. The physician was contacted and advised her to give BENADRYL to her son. The rash lasted 4-5 days. At the time of the report, the patient had recovered. No laboratory studies or diagnostics were performed. The mother sought medical attention for her son via telephone call. Additional information is not expected.
about 20+ hours after vaccination resident was having hard time breathing, 911 was called.  Resident coded multiple times at the  facility after CPR she was taken to ICU.  She coded again and was placed on life support.  Due to her choice to not be on life support she passed on 11/26/2021.
FIVE DAYS AFTER VAX, PT WENT TO GIVE BLOOD: HAD ELEVATED SGPT OF 160. TEST REPEATED 12-28-89 AT PHYS OFFICE AND SGPT LEVEL WAS 70.
Pt developed "large red area at site of injection within 12 hours". Area warm to touch and increased in size over 24 hours. Private MD treated with Augmentin and Rocephin IM. Treatment in progress.
23 year old patient received VFC stock vaccine by error - patient receive pediatric dose of Hep A and Hep B.
Confirmed Breakthrough Case  COVID-19 (Pfizer) 1  02/11/2021  Pfizer EM9810   COVID-19 (Pfizer) 2  03/04/2021  Pfizer EN6201   COVID-19 (Pfizer) 3  10/20/2021  Pfizer EW0183
Intense flu-like symptoms for 3-4 days; arm tender at injection site, aching joints, tiredness
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) was reported to be 1) 15-JUL-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Left breast grew significantly larger (at least 1 cup size, ) than right breast after second dose.
08Sep89 pt vax w/ 2nd hepta B; 09Sep89 exp muscle cramps, pain + edema in left hand + foot, progressed to both hands on 15Sep89.  16Sep89 unable to walk due to pain. w/ to ER and tx w/ APAP. Dx as having serum sickness.
Nausea and Vomiting: vomitted twice evening of 03/21/2021, still feeling nauseaus on 03/22/2021 at 2:30pm Headache: took tylenol for that, still dealing with the headache almost 24 hours later Dizziness: subsisided on it's own around 10pm last night Increased heart rate: went from 70 to 145 in one minutes at 5:47pm, went back down to normal heart rate around 6:30pm on 03/21/2021 Mild rash at vaccination site: did not take any medication, but disappeared this morning at 6:30am
PATIENT'S FIRST 2 COVID-19 VACCINE DOSES WERE OF MODERNA; PATIENT WAS MISTAKENLY GIVEN PFIZER FOR HER 3RD DOSE BY ONE OF OUR VACCINATORS TODAY.
vaccine leaked out of patient's arm after administration; A spontaneous report  was received from a healthcare professional concerning a 55-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine leaked out of patient's arm after administration.  The patient's medical history was not provided. Concomitant product use was not reported.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020 some of the vaccine went into the patient's arm and then leaked back out.  The health care professional estimated the leakage amount to be about two drops or 0.1 mL. The patient had no other adverse events or reactions. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, vaccine leaked out of patient's arm after administration, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # Lot #037K20A. There were no reported AEs associated with this case of incorrect dose administered.
This spontaneous report was received from a medical assistant and was referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, multiple patients were vaccinated with improperly stored PROQUAD albumin status therapy type rHA, lot number M035690, expiration date 06-FEB-2018, subcutaneously (dose was not reported). The vaccines were reconstituted with properly stored sterile diluent. The vaccines were stored in 42 Fahrenheit degrees for 17 hours, and previously in temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 16 hours. The call was not because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA007281.
Received vaccine on 2/17 at local health department clinic and presented to the reporting person's facility ED on 2/24/21 with a 4 day h/o N/V and headache.  patient was provided symptomatic treatment and discharged to home.
Severe nausea and vomiting , dry heaving, subconjunctival hemorrhage, severe headache and sinusitis
Heart palpitations, increased heart rate, increased blood pressure, shaking legs, overall feeling of unwell/uneasiness; since initial date of incidents, increased heart rate comes and goes
Shot was given around 530pm.  at 12 hours nausea, dry heaving.  at 24 hours 103 fever, body aches, headache, ocular pain.  felt good the next morning.  at 48 hours 101 fever bodyaches, not as bad and woke up with sweats in the middle of the night to feel great the next morning .  Had a nightly headache around 6pm each night with constant localized redness over the injection site, no lymph nodes this time for the following week.  everything gone within 1 week after.   Only took ibuprofen/tylenol for fevers and bodyaches.
Patient came in for second COVID vaccine today. Stated she had dizziness, nausea etc with first dose of vaccine. Decision was made to administer vaccine while patient was laying down. After injection patient started feeling dizzy, lightheaded and nauseous. Patient also has a history of diabetes. Stated that she had eaten breakfast this morning. Drank one juice box and refused a snack. Patient was lying down for 45-50 minutes before she started feeling a little better. Patient then sat up on the floor and continued to feel dizzy for another 10 minutes. Decided she could try to stand up and sit in the chair. Immediately after felt dizzy and lightheaded again. Water was offered to patient and she accepted. Sat for another 10-15 minutes. EMS transport was offered but patient declined. Patient was engaging in conversation and telling nurse how she was feeling. After 10 minutes started feeling better. Indicated that she felt she could drive herself home and nurse felt confident that she was better. Walked patient out to the car.
migraine headache, woke up 12/28 with 2 blisters near lower back
Constant, pervasive fatigue since booster May 5, 2022 and from the 2 injection COVID shots on March 9, 2021 & March 30, 2021.
Injection site pain; Wrong injection technique; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L794, expiry date 21st September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving Shingrix.  The patient felt they did not given it high enough in the deltoid, which led to vaccine administered at inappropriate site.
Unilateral axillary lymphadenopathy occurring on the left side; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 06Oct2021 (Lot number: EW0170) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19,, brand=PFIZER,, brand unknown=False,, lot number=EL1283,, lot unknown=False,, administration date=20Jan2021,, dose number=2), administration date: 20Jan2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (product=COVID 19,, brand=PFIZER,, brand unknown=False,, lot number=EK9231,, lot unknown=False,, administration date=30Dec2020,, dose number=1), administration date: 30Dec2020, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Oct2021 10:00, outcome "recovered", described as "Unilateral axillary lymphadenopathy occurring on the left side". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Facility type vaccine: Hospital. No other vaccine in four weeks. The patient experienced unilateral axillary lymphadenopathy occurring on the left side. The vaccine was also given in the left deltoid. No covid prior to vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient reported feeling dizzy, lightheaded, nauseated, and shaky Patient provided with water and seen by medical team, patients  blood pressure and heart rate low Ambulance called for medical transport  Patient advised and agreed to go to hospital Patient transported to hospital via ambulance
unusual dream; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the 2nd of two reports. This consumer reported for (his friends wife) that a female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose and was previously administered first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that the second night after the second shot he had a dream that someone or something had ahold of him three different times trying to pull him somewhere he didn't want to go. He had a phone call from a friend of him two weeks later. He said his wife and he had recently had the Covid shot and asked if he had any reaction. Reporter said no and asked if they had reactions. He said no. But he told him of his unusual dream. He said the second or third night after the second shot his wife woke up screaming and related to him that someone had ahold of her and was trying to drag her somewhere. Reporter was wondering as it was very unusual to have the same type of dream shortly after the second shot. Event abnormal dreams was considered non-serious as reported. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021216334 same reporter/drug/AE, different patient
Moderna COVID-19 Vaccine EAU  Approximately 12hrs (10pm) after receiving the first dose I had severe, uncontrollable chills, severe headache, & nausea. The chills lasted throughout the night and were gone by the next morning. The headache & nausea continued for the next day and half but were less severe than the initial reaction. In addition I felt lethargic for about 2 days after the chills stopped.
At about 1:00PM multiple symptoms occurred at the same time. I felt deep pain in the center of my lungs and immediately had difficulty breathing while this was happening, I had sharp pain in the inside of my ears. The severity of pain and diff. breathing lasted about 10 min and for a total of 20 min I had pain and less difficulty breathing - after 20 minutes, I could breathe much better but had to keep catching my breath, had a light cough during the time I had to catch my breath, and my lungs felt irritated. During all of this, my heart felt like it was beating fast, my body began to ache, my head began to hurt, and I started to feel a little nauseous. By 3:00PM the nausea was increasing and I felt like I was developing a fever. I called my doctor's office to find out what was going on. Since my breathing was better I was told to come to the hospital if it worsened again and that I could take pain/fever reducers like Advil if I wanted to. As time went on the nausea and pain increased, my heart felt like it was beating fast and I did have a low grade fever. This worsened and I was severely nauseous and in pain, I could not take medicine or drink anything and I was extrememly thirsty by 7:00PM. I realized that I had to go the hospital for fluids and IV pain medicine.
The individual is currently hospitalized and tested positive for COVID-19. During the case investigation, the case's family member revealed that the case had a stroke after getting her first dose. We are unsure of if this was previously reported and have limited information about the event itself. We want to report it just in case it hadn't been done before. We also wanted to report that the case is currently hospitalized at Medical Center because she has fluid in her lungs, as well as a UTI.   If you need more information from us, please don't hesitate to reach out and we can look up when / where the case was vaccinated and assist with any further investigation.
pt recvd flu vax 31OCT94 & 7NOV94 devel fever (103.8 ax), chills, malaise, & muscle weakness; Medical Affairs comment: for those nine yrs of age 7 older, single dose of flu Shield is recommended;
Vaccine reaction (varicella). Symptoms include fever and rash - scattered papules and pustules on trunk, face and back.
Patient admitted as observation on 7/25 due to acute respiratory failure with hypoxia 2/2 COVID-19. Patient was tested for COVID-19 and was positive on 7/25.
A non-serious spontaneous report of inadvertent administration of expired Flumist was received from a nurse concerning a patient of unknown age in a pediatrician's office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medications errors that occurred shortly after the product expired. Follow-up received 07-Oct-2008. No adverse events had been reported. Follow-up information received on 20 Mar-2009 included Product Complaint Investigation results.
last noc 5hr p/vax started getting red & swollen;MD recommended cool compress to site;pt also reports took DPH;states swelling has gone down but heat & redness still there;
Developed Myocarditis which was picked up Oct 24, 2022. Fatigue, shortness of breath on occasion, rare palpitations
severe chest pains starting around dinner time the day of shot and fatigue,  Dizziness and light headedness Muscle soreness throughout the body
Swollen painful to touch lump above clavicle with discomfort to surrounding areas of neck and clavicle.
Suspected syncope VS seizure.  Five minutes after immunization, patient felt odd, then per mom, her legs "flipped out from her body"- mom caught her torso; arms extended and entire body stiffened X seconds. Then, approximately 15 sec of clonic movement of legs. Teeth bit lower lip. Then, big gasp of air, and patient "came to; though pale and slightly disoriented X 5-10 min, and tired for at least several hours after.  Amnesia of event. To Emergency Department for evaluation.
Patient expressed her arm got swollen at injection site and hard. She reported no pain and also not warm to touch.
approx 2yrs p/vax pt exp breakthrough varicella w/approx 20 scattered diffuse 1mm vesicles surrounded by small unit erythema.