chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 25-Feb-2012. On 27-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
the redness around the site came back; the redness around the site came back; headache; body aches; chills; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3246 and Expiration Date unknown) via intramuscularly on 12Jan2021 08:15 AM (Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via intramuscularly on 21Dec2020 05:15 PM (Right arm) at single dose for COVID-19 immunisation. With first dose, patient had redness to the site the day after injection. It was probably about a quarter to half dollar in size and was red and inflamed but went away and faded as the week went on. Then about a week after that vaccine, the redness came back but it was itchy, hot to touch, and hard. Over the next day or so it grew quite large (have pictures for comparison throughout the days). Treatment included oral antibiotic and it slowly began to fade and go away. Other medical history was reported as Attention deficit hyperactivity disorder (ADD), eczema, psoriasis. The concomitant medications included unspecified Birth control, vitamin b complex (VITAMIN B) and ergocalciferol (VIT D). No other vaccine in four weeks. After second vaccine patient had a typical immune response- headache, body aches, chills, etc on the first day after vaccination and then on the second day post vaccination the redness around the site came back. Patient worried it was going to continue to grow again. The outcome of events was unknown.
Thundering sound in left ear began middle of the night after second vaccine. Tinnitus or ringing in ear but low and humming, and has continued the past 4 days.
Pt vaccinated with Pedvax HIB experienced stiffness in walking causing limping, & pain & swelling at inject site and lt thigh and knee. Was hospitalized on 1SEP90 where his temp 102.8, pulse 128, & resp rate 28, treated w/IV Cefazolin.
Assuming vaccine date is day 0: Temperature reached 38.3 on day 1.  37.8 on day 2.  Days 3 and 4, reached slightly elevated:  37.2 or so.   Headache: days 1 through 5 Pain at injection site: days 1 through 3 Sore throat: days 3 and 4 Fatigue/ weakness: days 1 through 7 shortness of breath: days 6 and 7
"Pt w/ no significant PMH. 2mins post vaccination, pt c/o dizziness.  Denies any other symptoms.  Vitals: @12:15 BP 100/60, HR 59, RR 18, O2 Sat 98% -- > @12:20 101/57, 65. Pt given fluids and moved to observation room to lay down. Pt reports improvement in dizziness.  Denies any other symptoms.  Returned to general observation for remainder of observation time. Pt ambulates independently, gait steady.  Pt stable and released form vaccination site."
pt exp a screaming episode approx 1 hr p/vax; episode persisted for 3 hrs; (no documentation in chart that cry was high pitched); tx included Advil/APAP/APAP w/Codeine & warm compresses @ site;
Left arm with inflammation and edema over area of flu vaccine measuring approximately 12 cm by 8 cm, tender to palpation. Mom instructed to administer Ibuprofen and apply ice to area. Mom advised to monitor area, also advised for patient to receive intranasal flu vaccine as alternative to IM injection due to discomfort.
7 minutes after vaccination, patient develops flushed sensation and heart palpitations.  Vitals signs assessed: BP: 160/76, HR111 (regular rhythm), , 02- 100% RA Recheck: 159/92, HR 130 Pt shaking, denies difficulties breathing or troubles swallowing Emergency Response Team called- Transported Pt to Emergency Room for evaluation
He reports right after getting the vaccine he got a golf ball sized lump on his arm. His left arm is now numb and it is radiating more "out". Denies any shortness of breath, headaches, or chest pain.
MMR, VZV and Hep A given 1/30/15 and 16 days later had complex seizure with respiratory failure requiring intubation also had Moraxella pneumonia and fever at time. No past hx of febrile seizures. No FHX of seizures.
Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient who was vaccinated with an expired dose of vaccine ACT-HIB (lot UI821AA and Exp. Date 19-NOV-2018) via unknown route in unknown administration site on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Chills, severe headache, bone pain, muscle and joint pain, general malaise all of which lasted about 36 hours. Headache lasted a day longer. This was a tiny bit less severe than my first injection (April), when symptoms included fever and nausea and lasted 3 days, with chills reoccurring for a couple weeks.
thrombocytopenia first noted on 3/15. second dose given 3/3
Joint pain for two weeks so far since second dose/started by aching then becomes extremely sore and then goes away in one day; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283, expiry: unknown), via an unspecified route of administration in the left arm on 08Jan2021 08:30 at a single dose for COVID-19 immunization on a hospital. Medical history included ADHD. The patient has no known allergies and no Covid prior to vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 18Dec2020 at 13:00 in the right arm for COVID-19 immunization. The patient experienced joint pain for two weeks so far since second dose (08Jan2021 09:30). It started in the left shoulder of the arm she received it in. That same day, it started in her knee on the left side, then went to both knees, moved to her right shoulder then left shoulder then to her right elbow for one day. Now it's her left shoulder again for one day. It started by aching then becomes extremely sore and then goes away in one day. The event was not treated.  The patient was not tested for Covid post vaccination. The outcome of the event was recovering.
Within one day, I started having intense pain on my LEFT side including shoulder blade, side of neck, upper back, shoulder, and left arm. My left hand and left arm were tingling and numb. This got worse as the week went on and I finally went to urgent care 5 days after the vaccine.  I also had a severe right leg vein cramp- where my upper inner thigh leg vein literally cramps during the night. I used to have leg cramps and have been taking potassium chloride and magnesium for a long time. After I had a left hip replacement in June 2021, my left cramps disappeared entirely for 2 months until I had the Modera vaccine.   I have had off and on the left shoulder blade and upper back pain (I've had to see a chiropractor and massage therapist regularly since August for this issue) since the first Moderna vaccine as well as another bad leg vein cramp in the past few weeks.  Because of these ongoing issues, I will not get the second Moderna vaccine.
Severe swelling and hardening of entire thigh, knee and part of upper calf. Redness of entire thigh. Pain, difficulty walking. Irritability. All continuing into 48 hours.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a year after receiving SHINGRIX, the patient experienced dizziness and energy decreased. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the headache, dizziness and energy decreased were not recovered/not resolved. It was unknown if the reporter considered the headache, dizziness and energy decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the expected reaction for a few days, but about 6 weeks later the patient continued to have the reported 1% reaction of mild headache and slight dizziness, and low energy. The patient finally had an office visit with his primary care physician to review the situation, she felt that his discomfort seemed to line up with the 1% he reported having this problem, she or we found no information on 1, and the patient queried if how long this might continue and how to gauge if or when he should take the 2nd dose.
No additional AE; improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 02-MAY-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (0.5 ml/ once, lot#: x004813, expiration date: 28-JUL-2024; route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at 46.74F for 2 minutes (product storage error). No additional adverse events (AEs) were reported (no adverse event).
p/vax pt had rash on face given DPH;mom states this happens when gets shots;rash disappeared p/DPH given;
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who had body ache, stiff neck, headache, 102.1 Fahrenheit temperature, vomiting and dizziness, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 24-Sep-2018, the patient received a dose of suspect MENACTRA (lot number: U6016AA) (expiry date, dose and dose in series was not reported) via intramuscular route in the left deltoid. On an unknown date, following the vaccination the patient experienced body ache, stiff neck, headache, fever, vomiting and dizziness. Relevant laboratory test results included: Body temperature - On an unknown date: 102.1 Fahrenheit Final diagnosis was dizziness, vomiting, 102.1 Fahrenheit temperature, headache, stiff neck and body ache. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as recovered on an unknown date. List of documents held by sender: none.
She received vaccine at around 12:45pm and later started complaining of a headache at 1pm. 5 minutes later she complained of feeling dizzy, then she started complaining of her throat closing. Epipen was administered and ambulanced was called. She left with the ambulance to the ER.
rash developed in its place; Blisters worsen & spread across both arms, increase in itchiness and discomfort; Blisters observed all over right and left hand; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patients relevant medical history and concomitant medications were not reported. The patients known allergies to medications, food or other products was not applicable. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 02Apr2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced blisters all over right and left hand. On 02May2021, the blisters worsened and spread across both arms, increase in itchiness and discomfort. On 03May2021, the patient was prescribed 6-day unspecified steroids plan to start: 4mg each, 6 pill/day with tapering down of 1 pill/day. On 10May2021,unspecified steroids helped reduce blisters, a rash developed in its place. On 11May2021, additional unspecified steroids were prescribed to help with the rash, started 40mg per day for 4 days, 30mg per day for 4 days, 20mg per day for 4 days and 10mg per day for 4 days. The events did result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events blisters, itchiness and rash were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2013US08337 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-year-old male patient His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12013 and expiry date: Oct 2014) at 0.5 ml intramuscularly on 18 Mar 2013. MENVEO was stored at 33-36 F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Breastfeeding; low weight for gestation period; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period) in a male infant of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 031L20A) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Anxiety in 2009.    MEDICAL HISTORY (Patient): The patient's past medical history included Exposure during pregnancy from 26-Jan-2021 to 26-Feb-2021.   On 26-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was in August 2020 and the estimated date of delivery was 11-May-2021. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. The cesarean delivery occurred on 06-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 2325 grams (5lbs 2oz). The outcome was reported as Term Birth NOS. Low weight for gestation period. At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) and UNDERWEIGHT (low weight for gestation period) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-031905 (Parent-Child Link).   See case MOD-2021-031905 for details regarding the Parent case.; Sender's Comments: QC Process - please don't review this case This is a case of product exposure during pregnancy with associated AEs of Exposure via breast milk and underweight . Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Initial unsolicited report received from a nurse on 22 October 2015. This case involves a (51-year-old) male patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE QIV NP (batch number UI443AC, expiry date 30 June 2016) in left deltoid on 30 September 2015. Illness at time of vaccination was cold symptoms and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as not applicable. Concomitant medications was not reported. On 04 October 2015, four days "7 days after vaccination" following the vaccination patient developed left (L) arm weakness and had to use two hands to lift" now states right (R) arm weakness as well. It was reported that, patient was seen by primary care doctor and unknown specialist. It was reported that, patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
p/vax pt exp a chickenpox like rash w/approx 20 pustules located on face, back, neck & chest;pt also had a fever, cough & gen malaise;pt seen in ER;rash;
About 24 hours after my third booster, I felt very tired, had achy joints and ringing in my ears.  The tinnitus has persisted and I still have high and medium pitched ringing in my ears pretty constantly.
patient received an expired Menactra vaccine / no AE; Initial information received on 06-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old male patient who was vaccinated with a 0.5 ml dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number U5986AA (expiration date 05-Aug-2019) via intramuscular route in the left deltoid On 05-Dec-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE RHA 3V (BACULOVIRUS) (FLUBLOK).  It was an actual medication error case due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received her first Pfizer Covid-19 shot on 04/18/2021. She had some light reaction to the first shot. Then on 05/09/2021 she received her 2nd Pfizer Covid-19 shot at 10:50am. She hads some chills and felt tired on Monday the 10th. She ate fine and went to bed early. She was up and talking when I left the house at around 7am on Tuesday the 11th. She said she felt a little tired and wanted to rest. I returned home at around 10:45am. I found her laying in the bed and she was cold to the touch. I performed CPR until the ambulance arrived about 15 minutes later. The EMTS tried to revivie her and then rushed her to the ER. When I arrived the Dr. said that they were unable to revive her by any means they had tried. The doctor informed me that patients heart had just stopped beating. That was even more of a shock to me because Patient did not have any history of heart troubles. I'm am completely convinced that the second Pfizer vaccine had a diverse effect on patient and contributed to her heart ceasing to function.
Tingling sensation; Stinging in the left hand; Stinging in some parts of the leg; Patient developed slight headache; This spontaneous report was received from a consumer referring to a 33-year-old male patient. The patient's concurrent conditions included vomiting, Human Immunodeficiency Virus (HIV) infection and blood pressure measurement. The patient's medical history included papilloma viral infection. Concomitant therapies included antiviral (unspecified)(ANTIVIRAL (UNSPECIFIED)), escitalopram oxalate(LEXAPRO), diacerein(ART), ASSRI and beta blocker. On 26-SEP-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) about 2 inches from the to of shoulder (strength, formulation, dose/frequency, lot# and expiry date were unknown) for prophylaxis. On 26-SEP-2019, after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient experienced headache, tingling sensation (paraesthesia), stinging in the left hand (pain in extremity) and some parts of leg (pain in extremity). Patient had routine blood work. Patient did not seek any medical attention. The outcome of events paraesthesia, headache and pain in extremity was reported as not recovered. The causality of the events was not reported with respect to suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Light-headed; Headache; Swollen eyelids and the area below; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Swollen eyelids and the area below), HEADACHE (Headache) and DIZZINESS (Light-headed) 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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING OF EYELID (Swollen eyelids and the area below). On 27-Feb-2021, the patient experienced HEADACHE (Headache). On 01-Mar-2021, the patient experienced DIZZINESS (Light-headed). At the time of the report, SWELLING OF EYELID (Swollen eyelids and the area below), HEADACHE (Headache) and DIZZINESS (Light-headed) outcome was unknown.            No concomitant medications or treatment details reported. Reported that all symptoms are ongoing and refused to give any other information because she was only seeking for medical advice about what to do and if she should go back to the ER.
Periodically experienced sharp uterine cramping, accompanied by lightheadedness and fatigue, beginning days after vaccine. Never felt before. Cramping initially lasted over a course of days, and now occurs about every week or so.