chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     It was reported that patient had no known allergies. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 08-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient had previously received the Bivalent dose 2 months ago, and was there to receive the Shingles vaccine, but accidently received a second Moderna Bivalent dose instead).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. Patient accidently received the third updated Bivalent dose. No treatment information was provided.
Beginning in July 2021 I noticed my iron levels going down.  Each time I went to give blood they were lower.  I have never had this issue in my history of giving blood and have given doubles before.  This past time 12/28 it was too low to donate.  When I went to my regular blood work visit it was low still and had elevated alkaline phosphatase.
Itchy rash at the injection site; Another rash about an inch away from the main site; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735,) via an unspecified route of administration in the left arm on 15Apr2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 15Apr2021 at 22:00, about 12 hours after the vaccination, the patient experienced itchy rash at the injection site and also another rash about an inch away from the main site. The reaction happened about 12 hours after receiving the injection and lasted about 5 days. The patient was wondering if a worse rash could happen when she gets the second shot. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rash at the injection site and another rash about an inch away from the main site were resolved on 20Apr2021 after a duration of about 5 days.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a female patient of unknown age referring to herself. There was no pertinent medical history or drug reactions/allergies reported. On 26-JUN-2015 (also reported as 10-JUL-2015) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route of administration were unspecified) in her left arm. No concomitant medication was reported. On 03-JUL-2015 the patient experienced warm to hot, painful large redness with 2 small round dots at the injection site on her left arm. On 13-JUL-2015, the patient experienced red dots that itched and a "line" connecting the dots in her inner right arm below the elbow. The physician reported that on 14-JUL-2015 the left arm developed a non-vesicular rash, and the right arm in which no vaccination was administered developed a vesicular rash. The patient reported on 15-JUL-2015 she experienced two big blisters on her right arm, one of which was bigger than the other, and also tiny blisters where the "line" was on her right arm. On 16-JUL-2015 both arms had small little red areas that were slightly raised. The patient was started on famciclovir by her unspecified primary care physician on an unspecified date. No lab tests were performed. The patient had an appointment in reporter's office for evaluation on 17-JUL-2015. At the time of the report, the patient did not recover and causality was not provided. Additional information has been requested.
Information has been received from a lawyer and an administrator for the estate of a deceased female patient of unknown age (DOB reported). No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-AUG-2012, the female patient was administered the ZOSTAVAX by a healthcare provider at a store pharmacy (Lot number, dosage and route of administration not provided). On or about 07-JUN-2016, the patient was treated by a healthcare provider at a clinic for the following injury resulting from her ZOSTAVAX use: Shingles. The administrator for the estate of a deceased female patient claims damages as a result of injury to themselves, and economic losses. The outcome of Shingles was unknown. It was also reported that the patient died on 11-APR-2018. The cause of death was not reported. It was unknown if an autopsy was performed. Upon internal review, the event of Death was determined to be a medically significant event. Additional information has been requested. Reported Cause(s) of Death: Death.
In less than 5 minutes I had facial flushing, increased/rapid heart rate, chest pain, shortness of breath (it felt like the air was taken out of my lungs)
pt recv vax 2JUN97 & 7JUN97 pt devel a varicella-like rash;
Received third dose of Covid 19 vaccine; the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient; also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect); body aches, pains; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported for a 23-year-old female patient (Reporter's Niece). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) at the age of 23-year-old as single dose at arm for covid-19 immunisation; hepatitis b vaccine via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported), at single dose for immunization. The patient's other medical history reported as none. The patient's dad was diabetic, but the reporter did not know for sure. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 23-year-old(Maybe 3 weeks before second dose) for covid-19 immunisation. Prior vaccinations (within 4 weeks) also reported as no. The patient previously received second dose of bnt162b2 on May2021 (22May2021 or 23May2021) at the age of 23-year-old for covid-19 immunisation and experienced body aches, pains, tiredness. The patient had the second dose of the Pfizer COVID-19 vaccine 10 days before. The day before yesterday, the patient had an appointment for the hepatitis B vaccine. By mistake, the pharmacist had administered the Pfizer COVID-19 vaccine to the patient and at the time of the report, from Jun2021, the patient was experiencing minor adverse events that were similar to the adverse events she had experienced during her Pfizer COVID-19 vaccine second dose. She did also get the Hepatitis B vaccine afterward(administered on Same Date of the Pfizer Suspect). She felt nervous because she had both. Report reported as non-serious. Events did not resulted in emergency room and physician office. Treatment reported as none. Relevant tests was none. The outcome of the events body aches, pains, tiredness was recovering. Information on the lot/batch number has been requested.
Periods went from lasting 5 days to just one day each month since starting Anthrax series of vaccines. Unable to conceive over past 5 months.
Received  ProQuad and began Augmentin 2-23-07. Developed hives over entire body beginning 3-4-07. Hive now resolving with Atarax therapy.
Headache muscle ackes- neck, back,  Site very sore Lethargic Mildly nauseated, no appetite Restless, miserable
At approximately 1:47pm the patient stated his throat was "tingly" and he kept clearing his throat.  The pharmacist gave the patient 50mg of diphenhydramine of which the patient took 37.5mg.  At 2:00pm the patient took 12.5mg more of diphenhydramine.  He stated he was feeling better and his throat was no longer feeling "tingly."  The patient said he felt ok to leave at 2:15pm and left the store.  The patient was instructed that prior to his next vaccination he should pre-medicate with diphenhydramine 50mg and would be required to be monitored for 30-60 minutes after vaccination.
This non-serious spontaneous case, initially received from other non-health professional on 05-Oct-2017, concerning a female patient of an unspecified age. The patient's historical vaccine included unspecified flu vaccine without any adverse effects. The patient's concomitant medications were not reported. On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: 01344611A, anatomical location: deltoid muscle of upper arm, route of administration: intramuscular, expiry date: not reported). On the same day, after vaccination, the patient could not move her injected hand or arm as hand was very sore. The patient also experienced fatigue, light-headedness, joint pain, muscle pain, diarrhea and was treated with Probiotic. It was reported that, patient would consult with HCP (health care professional) on TYLENOL and ibuprofen. 04-Oct-2017, the patient was recovered from the events. The reporter assessed the report as non-serious. Significant case correction received with IRD 05-Oct-2017: The route of administration of the vaccine was added as intramuscular. The listedness of the event fatigue and diarrhea were corrected. Non-significant case correction received with IRD 05-Oct-2017: Batch number (01344611A) was added on the screen. The narrative was amended accordingly. Significant case correction received with IRD 05-Oct-2017: The treatment received as "yes" was removed for all the events except diarrhea.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Pfizer Vaccine on 05/19/21 and 6/09/21. Presented to ED night of 1/23/22 c/o cough and SOB, Covid+ 1/24 admitted for acute hypoxemic resp failure 2/2 Covid PNA. Airvo 50/65% FiO2. Pertinent labs:  Na 134, Cr 0.94.  Procal 008. HS troponin 12. WBC 5.1, hgb 9.2 and plt 141. R pneumothorax 2/4/22, chest tube placed. Intubated 2/8 continuous leak noted, 2nd chest tube placed. 2/9 found to be HIT positive, pupils dilated concern for brain bleed. Heparin stopped, no argatroban 2/2 high ptts and neuro exam. Developed mutipressor shock despite antibiotics and covid therapies. Transitioned to comfort care. Tx'd remdesivir, baricitinib, covid 19 .  cresemba, meropenem, and levaquin.  Expired 02/10/22.
Administered flu shot to patient, patient sat at pharmacy for at least 5 mins while his dad was picking up his prescription. After they walked away from pharmacy, patient fell one time hear produce dept and again at floral dept. Dad was with him the whole time. Patient appeared pale skined, nothing noticeably different prior to and after vaccination. Patient never had a reaction to the flu vaccine in the past.
Itching, sweating, shortness of breath, flu-like symptoms, patient called pulmonologist and he prescribed prednisone via telephone rx to pharmacy.
5 pm on same date of shot, I was aches all over my body, I had chills, then sweats. My stomach hurt, I hade a headache and could not sleep. The next day was more of the same with throwing up add to it. I slept most of the day feeling  really bad. Called DR. told me to take Tylenol and ibuprofen. It didn't help much. I still couldn't eat anything, except for a few pieces of cereal. Saturday I started to feel better and toot some Ensure. It wasn't until Monday when I could do small things around the house and eat a little at a time. I am still very weak.
The day after I got the second COVID-19 vaccine, I had substantial muscle aches throughout my entire body and it became impossible to stand and / or walk  without significant assistance.   On the recommendation of my neurologistI took Tylenol at 5pm and the symptoms started to resolve within 2-3 hours.  The symptoms seem to have completely resolved within 48 hours after onset.
This was my third dose.  I had Covid in Dec 2020/early Jan 2021.  On dose 1 on 1/15/21 (right arm), I felt nothing - no side effects at all.  On dose 2 on 2/3/21 (left arm), I felt terrible flu like symptoms.  Aches, chills, pains, but also cough, sore throat, runny nose, congestion.  This dose 3 on 10/27/21 (right arm), I didn't have any side effects initially like feeling sick, but 24 hours later, I felt extreme weakness in my right hand.  I dropped 3 things in a row when I was trying to hold onto them.  My writst was even swollen.  They may have hit a nerve when they injected me but I had 24 hours of hand/wrist weakness.  Then, on day 4, I woke up to Covid arm.  I have a huge rash around the injection site.  It's a painful, warm, red lump that itches, burns, and hurts.  I"m on day 6 and it's still there.  It's not responding to benadryl cream or benadryl pills.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unspecified date between 03-AUG-2015 and 24-AUG-2015, the patient was vaccinated with the second dose in the PROQUAD series that was improperly stored (Lot # L007230, expiration date: 03-SEP-2016) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Lymph node swelling in axilla. Numbness in stocking distribution to arms and legs bilaterally.
Information has been received from a physician concerning a 23 year old female patient who during the last week of April 2007 was vaccinated IM with a first dose of Gardasil. Concomitant therapy included tetanus toxoid, tetracycline and hormonal contraceptives (unspecified brand). In June 2007, the patient developed nose bleed and bruising of her body. The patient's platelet count reached 2000 and was hospitalized for ITP (Idiopathic Thrombocytopenic Purpura). The patient was treated with intravenous immunoglobulin and high dose corticosteroids (unspecified). The patient responded to the corticosteroids (unspecified) but became intolerant to the side effects. There have been more than one attempts to taper the patient off the corticosteroid but the platelets decreased each time. As of 26-JUL-2007, the patient's platelet count was 8000. No other details were provided. Physician did not provide specifics on corticosteroid side effects that the patient developed. The patient had not recovered. The events nose bleeds, bruising of patient's body, and Idiopathic Thrombocytopenic Purpura (ITP) were considered to be life-threatening. Additional information has been requested.
On 8/8/02, pt noted facial asymmetry and inability to blink right eye. Dx'd with Bell's Palsy. Treated with prednisone. Also has a positive Lyme titer on 8/9/02. Is on medicines and is not yet healed.
This spontaneous report was received from a physician referring to a 68 year old male patient with diabetes mellitus, hyperlipidemia, gastroesophageal reflux disease, benign prostatic hyperplasia, unspecified knee surgery, unspecified shoulder surgery, cataract surgery, unspecified back surgery and unspecified hand surgery. The patient did not present drug reaction/allergy. On an unknown day in July 2012, the patient was vaccinated with ZOSTAVAX (route, strength, dose, frequency and lot number were not reported). No concomitant medications were reported. Fall 2012, the patient developed red, painful, burning, tingling and itchy rash over his trunk and face in intermittent intervals. The patient sought medical attention via visiting an allergist, rheumatologist and dermatologist and treatment was received as a physician prescribed ZYRTEC and another unspecified allergy medication which the patient stated did not help. No product quality complaint was involved. The outcome of the adverse events was reported as not recovered. The relatedness of the adverse events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
I recently got COVID; I recently got COVID; Involuntary muscle movements in my upper right arm and shoulder; I got Pneumonia from having COVID; the first dose was 11Jan2021 and second dose was 28Jan; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 11Jan2021 as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 44-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 28Jan2021 as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included High blood pressure, ADHD. Concomitant medication(s) included losartan (LOSARTAN) taken for hypertension, start and stop date were not reported; lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder, start and stop date were not reported. No prior vaccinations within 4 weeks. On 19Aug2021, the patient experienced covid, on an unspecified date in 2021, the patient experienced pneumonia from having covid, the first dose was 11Jan2021 and second dose was 28Jan2021, on an unspecified date in Feb2021, the patient experienced involuntary muscle movements in her upper right arm and shoulder, It happened on a daily basis. The patient underwent lab tests and procedures which included full blood count: unknown results on Aug2021 normal, metabolic function test: unknown results on Aug2021 normal, sars-cov-2 test positive on 19Aug2021. Patient visit emergency room for events (I recently got COVID, I got Pneumonia from having COVID). Therapeutic measures were taken as a result of recently got covid as Zetac 250 mg taken for 5 days and a steroid (Prednisone took 40mg for 4 days), no treatment received for event (I got Pneumonia from having COVID, Involuntary muscle movements in my upper right arm and shoulder). The outcomes of events (the first dose was 11Jan2021 and second dose was 28Jan2021, recently got covid, Involuntary muscle movements in her upper right arm and shoulder) were unknown, and the outcome of event (I got Pneumonia from having COVID) was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
sore throat, coughing, general discomfort, t99.3 was highest 12NOV92; 9NOV started Hismanal x 7 days; feeling better 24NOV92;
SORENESS FOR A FEW DAYS AT SITE OF INJECTION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported..  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced soreness for a few days at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of soreness for a few days at site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220707759.
The day before I was walking and working out and the next morning I had a hard time walking. The mussels in my legs and back are now tight and need stretching everyday. It is still that way after nearly 5 months out. I had HSCT back on October 12/2022. Dr. who does HSCT (not mine) felt I was having a inflammatory reaction to the shot. My neurologist would not give meds.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time). On 27-Aug-2021, PRODUCT STORAGE ERROR (administered past the 30 day refrigeration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided.
This spontaneous report was received from a physician via a company representative and refers to a 50-year-old male patient. No information regarding patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On an unknown date, the patient received ZOSTAVAX, single injection, subcutaneously (lot# and expiration date were not provided) for prevention of Herpes Zoster at a pharmacy. On an unknown date, reported as "days later", the patient had shingles. The physician reported that the patient recovered on an unspecified date. It was unknown whether any treatment was given for shingles and whether the patient sought medical attention. No Product Quality Complaint (PQC) was involved. The relatedness between the event and the ZOSTAVAX was not reported. Additional information is not expected as the reporter did not wish any further contact.
Patient was unable to get up and walk starting on the morning of 09/28/2017. She went to physician appointment on the 28th. She indicated the doctor thought a viral infection was affecting her artificial knee joints.