chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Ipol from a MDV that was opened and deemed not safe to use / no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a physician.   This case is linked to case 2019SA264028 (same reporter).  This case involves a 12 years old female who received 0.5 ml dose of IPV (VERO) lot PIE70 via intramuscular route in the right arm on 12-Sep-2019.  The patient's past vaccination included OPV (Polio vaccine live oral). Past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HPV VACCINE (HPV VACCINE) and HEPATITIS A VACCINE (HEPATITIS A).  It was a actual medication error case due to incorrect product storage. It was reported that 2 patient's that received Ipol from a MDV that was opened and deemed not safe to use. The physician mentioned that she thinks that she should be able to use her clinical judgment as to whether or not to reinjection her patient's and she did not believe that this situation warrented it.  At a time of reporting no adverse event was 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.  List of documents held by sender: none.
About 3 weeks a ince receiving the vaccination, I am Having a dull and sharp pain in my left shoulder near the injection site when I move or manipulate my shoulder. I have Also developed a sharp pain in the left side of my neck when I tilt my head up or to the right side.
Patient received 1st dose of SHINGRIX on 5-29-18.  By 5-31-18, patient states she was broken out in an itchy rash all over her body. Her home health nurse recommended CLARITIN and to apply hydrocortisone 1% three times daily. The patient came to the pharmacy 6-25-18 to let us know of the reaction. Pharmacy has called her healthcare provider for follow up.
Moderna 6mo-5yr vaccine given to 6 year old. no side effects noted, parents notified after administration
localized bruising at the site of the injection; Area is very sensitive to touch; Skin is discolored; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site bruising, touch sensitivity increased and injection site discoloration. On an unknown date, the outcome of the injection site bruising, touch sensitivity increased and injection site discoloration were unknown.   It was unknown if the reporter considered the injection site bruising, touch sensitivity increased and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's son. The reporter stated that, the patient had localized bruising at the site of the injection. The area was very sensitive to touch and the skin was discolored. Additional information was not provided.
Immediate, severe left arm pain. Tingling and numbness in left hand. Arm movement limited. Still in pain after 3 weeks.
Over 4 hours, gradual tightness in throat followed by pain at base of throat and pain in center, upper chest. Asymmetric, high blood pressure in left and right arms over an hour. (220/? on right; 180/? on left) Throat tightness subsided but pain remained at base of throat and pain increased in center of chest and was followed by tightness of breath within 24 hours. Pain in chest and shortness of breath was identical to symptoms I experienced for 4 or 5 months following contracting COVID-19 in March, 2020. No fever. No signs of allergic reaction. Pain and shortness of breath lasted over 72 hours and began to improve in the 24 hours following that. Approx. 5 days of symptoms.
I got my flu shot and I have the flu; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated I got my flu shot and I have the flu  after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for flu  On an unknown date the patient stated I got my flu shot and I have the flu  (influenza) (unknown latency)   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Arm and facial swelling, metallic taste in mouth, dizzy and lightheaded within a few minutes after vaccine. Benadryl 50mg IM given then taken to the ED for further evaluation and treatment
Information has been received from a  registered pharmacist concerning a approximately 65 years old male who on 13-FEB-2009 was vaccinated with ZOSTAVAX (Merck) (lot number, route and site not reported).  Concomitant therapy included CRESTOR, MSD, PROZAC and promethazine.  On approximately 15-FEB-2009,within 48 to 72 hours after receiving the vaccine, the patient developed gynecomastia.  He complained of left breast enlargement, tenderness and inflammation.  The patient had sought unspecified medical attention.  Mammogram was performed, but the result was not reported.  At the time of reporting, the patient didn't recovered.  Additional information has been requested.
Angioedema; Urticaria; I developed urticarial vasculitis; I started having tremors; Spasms; Nerve pain on my right side down my shoulder; Heart palpitations; chest pressure; Head pressure; I have inflammation all over my body; numbness in my feet; I am unable to walk at times; Bruising from head to toe; passing blood clots from my vagina; passing blood clots from my vagina; This is a spontaneous report from a contactable consumer (patient). This 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid patient from an unknown date and unknown if ongoing; and uterine ablation from an unknown date reported as 11 years ago. Prior to vaccination, the patient had no known allergies, had not received any other vaccines in 4 weeks and was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of the vaccine. The patient previously received the first dose of BNT162B2 (lot number EN6203) in the left arm on 18Mar2021 at 11:00 (at 41-years-old) for COVID-19 immunisation. The patient reported that 14 days after her second dose on 22Apr2021 at 05:30, she developed angioedema and urticaria. Then she developed urticarial vasculitis. She started having tremors, spasms, nerve pain on her right side down her shoulder, heart palpitations, and chest pressure. She had developed head pressure with nerve pain and had inflammation all over her body that was causing numbness in her feet where she was unable to walk at times. She had bruising from head to toe that no doctor could explain. She was passing blood clots from her vagina that had a uterine ablation 11 years ago. The events were reported as serious for disabling. The events required a physician office visit, and the patient was treated with " medicines, supplements, HBOT, EBO2, etc." The clinical outcomes of the events were not recovered. On 01Sep2021 the patient had a blood test for SARS-COV-2 Total Antibody Interpretation which was negative.
On about 4pm 10/26/09 received 0.5 ml PNEUMOVAX in left deltoid. Achiness within 1 1/2 hours after shot and redness and swelling- firm- 3" below injection site and 5 1/2" L x 5 " width-slight warmth @ site (redness site-no temperature
Within 24 hours patient developed large red, sore, swollen, hot area where Varicella was given DTap also give IM in that area and DTap given IM Varicella given SC. 12/9/2009 PCP records for 11/12/2009 with c/o's erythema at vaccine site, rx'd benadryl and cool compresses to area.
pain in her arm; painful to turn her neck too; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 (1st dose, ), for COVID-19 Immunization; Bnt162b2 (2nd dose, ), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm"; NECK PAIN (non-serious), outcome "unknown", described as "painful to turn her neck too".  Additional information: Caller wanted to know about the timing for the second booster dose of Pfizer-BioNTech COVID-19 Vaccine. Caller on behalf of a friend of hers wanted to know if the side effects that her friend experienced after receiving a Pfizer-BioNTech COVID-19 vaccine (booster dose) had been reported. Caller stated that her friend had received the first, second and booster dose of Pfizer vaccine. After the booster dose, she experienced pain in her arm and it was painful to turn her neck too. Caller stated that her friend is an older person. She wanted to know if those side effects had been reported and if her friend should receive the second booster dose that was recently announced. Caller stated that she had already waited on hold for 22 minutes when I offered to put her on hold while I looked for her information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient fainted few minutes after covid-19  vaccine was given to her.  Was transported by ambulance to unknown hospital.
Pfizer COVID vaccine #3 given 10/06/2021, lot #30158A; pt had a positive COVID test on 2/22/22; 4/25/22 pt admitted to hospital with another positive COVID test, as a transfer from medical center; pt in respiratory failure, intubated; sepsis; hypotension; O2 sats 86% on 6 L via NC; on ABX, steroids; multi-organ failure; transitioned to comfort care/hospice; pt died in the hospital
Mild fatigue and body aches x 1 day, fever started up to 103 and then full body rash.  More severe symptoms started 1/7-1/8, worsened 1/9.  Had close contact with two children and husband, but none have any symptoms.
immunocompromised given 0.25ml for the 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 04-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose). On 04-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised given 0.25ml for the 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Cough, runny nose, congestion 4 am on Sunday night vomiting twice and fever 103.
On 8-9-2010 client was given H1N1 0.1ml. intradermally instead of TB-PPD in the left inner forearm. 8-11-2010. Left  forearm was slightly reddened - size 2 x 3cm. No complaints of discomfort. Recommended antihistamine and ice pack to sire if needed. 8-13-10 - Site unremarkable.
This spontaneous report was received from a back office lead referring to a 48-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, dose unknown, intramuscularly, in left deltoid (a dose number was not provided). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received Tdap shot without incident in left arm. Patient was asked to remain for 15 minutes and asked if he wanted to sit down- patient wanted to shop in store and seemed fine. After several minutes patient passed out on way back to pharmacy (within the store). Patient was dizzy and shaken so EMS was called and rendered assistance. We will follow up with patient in 1-2 days.
PATIENT RECEIVED A DOSE OF PFIZER BIVALENT BOOSTER DOSE WAS PAST BUD, SPOKE TO DAUGHTER AND STATED HAS NOT EXPERIENCING ANY ADVERSE EVENTS. WILL CONSIDER TO SCHEDULE TO BE RE-VACCINATED
No signs or symptoms that she was going to faint. Pt came to right away. Pt kept lying flat for 20 min. Doctor checked her over.
The daughter of the patient stated that her mother is a cardiac patient and has a stent.  The patient always has edemas on her legs but the day after the vaccination she observed edema and report pain on the left thigh.  The following Monday  she visited the MD and he order a venous Doppler. The result was a thrombosis on the right leg .  The patient was put on medication (Xarelto)
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a less than 3 years old male patient who received 0.5 ml of vaccine FLUZONE QUADRIVALENT (lot UJ025AC, exp date: 30-Jun-2019) via unknown route in right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. It was a case of actual medication error due to overdose. (It was reported that FLUZONE QUAD 0.5 mL dose given to child under 3, patient received pre-filled syringe 0.5 mL dose instead of indicated 0.25 mL.). It was not reported if 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 holders 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.
She got her vaccines, her arm was hurting after the first day, she felt a little flu-like, but nothing much.  The next morning she went for her walk and then she came back, and usually she feels good after she walks and instead she felt very weak.  She did her VS and her blood pressure was 95/71, which is normal for her.  Her pulse was 102, oxygen saturation was 92.  She kept retaking her pulse and instead it was going up, which went up to 109.  She was weak the whole morning, but the pulse ox went back up in less than an hour.  The weekness persisted for 5-6 hours.  The heart rate lasted for about 3 hours.  By the evening of that day she was feeling much better.  She was concerned as she is not one of these people people that gets weak, sleepy but not weak.  She does not get tired like most people, but that day she was so tired and extremely weak.  The only time her heart went above 90 or high 80s other than being on a treadmill, otherwise never.  Her pulse is always in the 70s.  She is suspicious of it being the RSV as this was the first time she had ever gotten it.  She did not take anything for her symptoms, other than drinking water.
fever of 104.6;had tepid bath & motrin fever decrease to 102.1;hr later fever inc 104.8 & lethargic;to Er CXR showed pneumonia lt lower lobe;blood work & urine ordered;tx ATB;T103.1, Hgb 9.9, HCT 29.9;lymphocytes 80 segs 14;
Symptoms started 5/28.    Symptoms include: Constant Severe pt received the Moderna Covid-19 vaccine on 5/27 at 1930. Pt stating that pt's symptoms started this am. Pt developed fever (current temperature at 104.7 via forehead thermometer), severe head and neck pain, lightheadedness. pt feeling like pt's hands are "on fire". pt stating that pt's hands "feel weird". Pt passed out in pt's computer chair x 2 this am. Pt has not reacted to vaccines in the past. Pt A & O x 4. Pt c/o tachypnea.     Patient Has tried prescribed "headache" medication with none improvement.    Pertinent negatives include: No chest pain. No diarrhea. No vomiting. No injury. No rash.                Pertinent Medical History: none Patient went to ED 5/28- This is a 41-year-old female with history of migraines 12 hours post 2nd mid during the COVID immunization who presents emergency department for evaluation of myalgias, fever at home, fatigue, headache.  Headache is similar to previous migraines.  Patient has a benign  exam with a normal neurologic exam.  Initially noted to be tachycardic at triage on recheck this is normal she is not tachycardic on my evaluation.  Participant should decision making the patient.  Symptoms thought to be likely related to immune response to immunization.  She did note feeling dizzy earlier notes she has been eating and drinking normally.  Offered her screening labs, EKG, migraine cocktail and she declined each.  She notes she would prefer to go home and rest as this will often alleviate her headache symptoms.  Given dose of Tylenol here.  Provided with work note.  Normal sequela of COVID immunization discussed return precautions discussed.  Patient notes she had COVID the end of March and testing today could be a remnant positive from this would not recommend repeat She and husband are comfortable plan.  Patient is reassured, agreeable with plan, educated regarding return precautions, discharged in stable condition, all questions answered.
2 days after noted bruise at site of injection then became red, warm, swollen, traveling to distal/medial, aspect of upper arm. Redness measured 155x60mm
I had 1 episode following the first injection that lasted 4 days. I experienced severe fatigue, muscle and joint pain, body ache, and headache. I then had 2 episodes of the same but more severe symptoms following the second injection. The first lasted 3 or 4 days and began about four days after the second injection. The second occurred beginning March 14th and lasted until the following Friday. The symptoms since then tend to recur the day following being physically active for a  full day but are not as severe and last for less than half the day.  These symptoms are very similar to those I have experienced on a regular basis since undergoing a series of major surgeries approximately 10 years ago.
Erythematous, raised lesion, involving majority of deltoid, painful to touch. occurring within 2 days of administration. no other constitutional symptoms noted. no discharge. required 7 day course of Keflex at local urgent care. seen at follow up on 10/3/22; lesion now annular with crusting and peeling, not raised, minimal elevated, approx 6cm x  6cm, with no other symptoms and now being treated with OTC ibuprofen prn.
Left arm with 5x2cm area of warmth and redness.  Treated with ice/heat.
No symptomatic side effects reported. No additional AE details.; Inbound call from HCP who stated a 1 year old was inadvertently administered PROQUAD and VARIVAX concomitantl.y; This spontaneous report was received from a Registered Nurse regarding a 12-month-old patient, of an unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 14-DEC-2022, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W010527, expiration date: 25-SEP-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis; and varicella virus vaccine live (oka/merck) (VARIVAX) lot #U027326, expiration date: 02-SEP-2023, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Accidental overdose) which were reconstituted with sterile diluent, lot #W000452 and expiration date: 23-JUL-2024. No adverse events were reported.
parent reports pt wouldn't walk on leg, ran fever-took to ER contacted MD next day-reports pt is doing fine
Parosmia; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL2964) via an unspecified route of administration in the arm left on 27Mar2021 at 09:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, seasonal allergies, COVID-19 from an unknown date in Dec2020 and stop date was unknown and anosmia for 5 days. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously took amoxicillin (AMOXIL) and experienced allergy. On 30Mar2021, the patient experienced parosmia. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event parosmia was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Had body aches, chills, and a fever. Took Ibuprofen that helped