chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 102.0 degrees F; redness at injection site; swelling at injection site; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix and FLUBLOK (intramuscular). On 24th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 25th September 2020, the patient experienced injection site erythema and injection site swelling. On 26th September 2020, the patient experienced fever. On an unknown date, the outcome of the pain in arm, injection site erythema, injection site swelling and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, injection site swelling and fever to be related to Shingrix.  Additional details were provided as follows: The patient's body temperature was 102.0 degrees F. The patient reported arm soreness, redness at injection site, swelling at injection site. The reporter consented to follow up.
Major Arm swelling from the shoulder down to the elbow, redness, chills, fever 101.6.
Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored VAQTA (lot # M027879, expiration date 24-JAN-2018; lot # reported as M003611, expiration date 02-MAR-2018) (route and dose were not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Lot number M003611 is an invalid lot number for hepatitis a vaccine, inactivated. Additional information has been requested.
1.  Extreme nerve pain, both arms from just below shoulders down through the thumb and index finger.  Pain has subsided 2.  Bells Palsy  3.  Increased Blood pressure and heart rate.  Roughly 25-30% 4.  Numbness in bottom of both feet 5.  Deep cough with mucus 6.  Diminished use of left hand 7.  Right shoulder pain 8.  Intermittent stomach and back pain 9.  Cramping in hands and feet 10. Shortness of breath  As of 12/19/21 pain in arms is not very bad, increased blood pressure and pulse are roughly 15% higher.  All the rest of the symptoms are the same.  As a result of the nerve pain and diagnosis of compromised discs  in my upper neck, I had  surgery to replace 2 disks on October 14th.  Not sure it did any good.
Completed my vsafe check in each day. Very mild symptoms. On day six I had what appeared to be a severe asthma attack (no history of asthma) while working outside. Continued working and symptoms increased, oxygen levels dropped, ended up in ER with elevated triponin. Echo and angiogram both normal healthy heart.
HIGH BLOOD SUGAR; GI BLEED; This spontaneous report received from a consumer concerned a 71 years old  female. The patient's height, and weight were not reported. The patient's past medical history included NIDDM (Non-Insulin-Dependent Diabetes Mellitus Diabetes).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  In APR-2021, the patient experienced GI (gastrointestinal) bleed. On an unspecified date, the patient experienced high blood sugar. It was reported that the reporter was not sure if the GI (gastrointestinal) bleed was just coincidence because the patient passed so soon after getting the covid-19 vaccine ad26.cov2.s. The patient had to go to her Doctor to get an unknown shot on the day of or close to the day of the vaccine, probably insulin because the patient had a 475 blood sugar. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 475 mg/dL. On an unspecified date the patient died from GI (gastrointestinal) bleed. Patient was lying there for a while. Patient had been bleeding when it was discovered on 11-APR-2021 that she had expired. Coroner's report said it was from GI (gastrointestinal) bleed. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of GI (gastrointestinal) bleed on an unspecified date, and the outcome of high blood sugar was not reported. This report was serious (Death).; Sender's Comments: covid-19 vaccine ad26.cov2.s-GI bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). covid-19 vaccine ad26.cov2.s-high blood sugar. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE; Reported Cause(s) of Death: GI BLEEDING
pt recv vax 29DEC95 & 3JAN96 devel lupus & was hosp;reporter stated pt was pregnant,but it was unclear from the info provided whether pt was pregnant @ time of vax or became pregnant;addtl info is being requested
Patient had inflammation and pain and injection site that spread down most of her left arm. Swollen lymph nodes in the armpit and groin prompted a call to her PCP who told her it was most likely an immune response reaction to the COVID 19 vaccine.
Patient became dizzy and nauseated after vaccination. Patient c/o not being able to see clearly. Feet propped in chair. Cool air and cool paper towels placed on neck and face. Patient vomited approximately 50-100 ccs. Stated that she felt better after vomiting. Coke and crackers given. After approximately 10 mins patient felt better and was able to ambulate to lobby with dad. Dad is a physician assistant. Advised dad to wait in lobby an additional 10-15 mins before they leave. Dad voiced understanding. Copy of immunization records given. Reviewed possible side effects of immunization(s). Advised for patient to wait in lobby for 20 mins after shot(s) to monitor for reaction.
The following are descriptions is a synopsis of information provided over the phone by the patient's wife on 5/10: At time of second dose patient was fatigued, lethargic, hyperglycemic, and experiencing brain fog. She states some of the symptoms started some time after his first dose but couldn't provide a time frame. On 5/6 he answered the Vaccine Questionnaire question of "are you sick today?" as "unsure" and further discussion was had with a pharmacist to verify he was eligible to receive vaccine. Neither the pharmacist or patient remember the details of this discussion.  Patient and wife have belief that his ethnicity contributed to dismissing of possible illness during the vaccine screening process, but due to the patient's lethargy and brain fog at the time, he could not provide specifics of the conversation. His wife was not with him during the screening process with the pharmacist or during vaccine administration. The appointment time was 4:55pm. The wife states the patient was so fatigued after the shot was administered on 5/6 that he was asleep in his chair in the observation area.  Later that day fever of 100.5 was noted and controlled by OTC ibuprofen 2 hours after the ibuprofen was administered. The wife states that he rapidly declined over the 3 days after second Pfizer vaccine and she called an ambulance on Sunday 5/9. From the ER he was admitted to the ICU with the primary reason for admission listed as hyperglycemia but a COVID was listed as a contributing factor. The COVID test administered Sunday was positive. He had high blood pressure, heart rate, blood sugar, and sodium. Patients vitals have since stabilized other than the sodium is still high. He is in ICU at hospital still very lethargic as of today 5/10.
Symptoms consistent with SIRVA: L shoulder pain onset 8 out of 10 within 2 hours, painful arc, pain at rest, within 36 hours unable to raise hand above head without severe pain. Have been icing, taking anti-inflammatories, and resting. Completing PROM on self to prevent frozen shoulder. It is now54 hours post vaccination, pain at rest is improved, but still  have severe pain and painful AROM arc.
Patient was given today another dose of Menactra by mistake / No AE; Initial information was received on 05-Feb-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 18 years old female patient who on 11-Jun-2018 received a first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported via unknown route in an unknown administration site and on 05-Feb-2020 was mistakenly given second 0.5 ml dose of same vaccine (lot U6586BA and expiry date 20-APR-2020) via intramuscular route in the left deltoid for prophylactic vaccination.     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on 11-Jun-2018 patient got her initial first dose of Menactra when she was 17 years old and on 05-Feb-2020 was given another dose by mistake .   It was an actual medication error case due extra dose administered.  No adverse reaction 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.  Information on the batch number was requested for first dose.
Started with itching arms and legs, progressed to little red white bumps, pimply in nature.  No other symptoms. Rash lasted 3 days and self treated with Benadryl.  No loss of work or other medical care needed.
Symptoms began on Sunday Nov 14th with fatigue after I woke up in the morning.  I continued to feel fatigued.  The  next day, Nov 15th I began experiencing shortness of breath, some flushing of my face, continued and increased exhaustion.  The next morning I felt even worse and was very light headed.  It felt like my heart was going to pound out of my chest.  I also had a pain in my lung area.  So I checked my blood pressure.  It was 244/137.   I called my local clinic and they called 911 to dispatch an ambulance to my house.  In the ambulance they started an IV and they gave me 4 baby aspirins.   Once I got to the hospital my BP was 179/102.
Pt recv vax on 3/6/97; 7/97 pt exp hair loss.
Patient states that 2 days after receiving vaccine, she has no memory of the events. Her spouse states that she was confused and weak and was taken to the ER and given IV fluids. It took a few days before the confusion resolved. The Hospital and MD told her it was a reaction to the vaccine and advised her to not obtain the second dose.
Felt really great and well rested until shot administered; one hour later, loss of taste, neck stiffness, and severe headache/dizziness by 12 noon.  Shot was administered free by employee health nurse.  Notified her of symptoms, and all she said was this was normal and gave me package insert.  Two weeks later, still getting sudden onset bouts of dizziness and neck stiffness.  Although never received flu shot before, am not a hypochondriac or have personal "beliefs" about flu shots.
Patient was given Moderna Covid vaccine 1st dose on 5/4/2021 and 2nd dose on 6/8/21. Patient was only 17 at the time of vaccination.  CDC has not approved Moderna for safe administration for anyone under 18 at this time.  No adverse or negative effects from the vaccine have been noted.
Moderna COVID-19 Vaccine EUA  Severe Dizziness/Light headedness Body Aches Fatigue Body Rash (Chest, Back, Neck) Low grade fever
Tachycardia: Normal resting heart rate is <60 BPM but was elevated to >100 BPM. After 24 hours contacted a healthcare hotline. After 48 hours increased dosage of beta blocker until tachycardia resolved.  Psoriasis: History of moderate psoriasis that was previously in remission requiring no treatment in prior five years. Within approx one week, psoriasis had flared up  and remained problematic for six months.
pt recv vax & devel an inj site rxn & hard to lift arm, strange sensation;addtl info was recv 31JUL96;pt recovered;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 10-FEB-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: J006955, expiration date: 07-JUN-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom called 2/21/13 - RN spoke to 16 y/o male pt who c/o waking up on 2/21/13 morning w/rash all over body. C/O rash being red round raised bumps that itch on face, trunk, arms & legs. Pt denied any wheezing, SOB. now or at any time. Pt denied weakness, rapid or irregular heart beat or dizziness.
intense itching (unbearable) w/in 1hr;swelling, heat, bruising @ site of inj (w/in 1 day increasing daily);itching disappeared when pt took DPh-never returned;
1. After vaccination my temperature rose over 103 plus and I took 1000 mg of Tylenol over the counter but it continued 2.After 12 hours whole body started etching specially hand wrist started swelling and too much not tolerable etching took medication Benadryl but till this morning March 29, 2021 ER could not stopped it so they gave steroid, I still have 30% of the same and doctor advise to continue Benadryl 50 mg everyday. This made my daily life Misérable
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated received a dose of RECOMBIVAX HB (dose, route, lot# and expiration date unknown) as an initial dose, and then a second dose seven months later for prophylaxis, which was not in accordance with the prescribing information. No adverse effects were reported in the patient. No other information was available. There was no Product Quality Complaint (PQC) involved.
Large red welt 6 days after vaccine. Tender, sore, slightly raised. Approx 3 inch round
This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had suspected Covid-19 infection and patient was in intensive care for Covid which leads to suspected clinical vaccination failure. Patient was hospitalized (date unspecified for unspecified days). It was reported that the patient was in intensive care for Covid and received the J&J Jab 5 weeks before. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000225871. Sender's Comments: V0: 20220409590- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related. 20220409590- Covid-19 vaccine ad26.cov2.s-suspected Covid-19 infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022; Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer/BioNTech Dose Number: 3/Treatment of COVID-19 25May2022". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive; (30May2022) Negative; (02Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications was received in 2weeks. Patient was treated with Paxlovid. Treatment start date was 25May2022. Treatment stop date was 29May2022. Indication was treatment of COVID-19. Tested negative for COVID on 30May after completing Paxlovid on 29May. Symptoms returned and tested positive again on 2Jun.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious.
severe pain on the left arm for 5 days  and then developed rash with blisters on the same arm.  Went to the doctor on 4/8/2021 and was prescribed Valacyclovir  1GM for 7 days.  Rash has dried up, but still having severe pain, tingling and sensitivity on touch .
Patient at appointed time for second dose and related this event. Patient reported that the vaccine site became progressively painful, swollen and bruised starting the day after the vaccination.  The swelling progressed including his hand, numbness in the ulnar nerve area. By 3-4 days after vaccination he was unable to lift his shoulder so  he saw his PCP who suspected a hematoma or thrombus but found neither. He then saw an orthopedist Feb 3 or 4 who was uncertain but sent him to Physical Therapy with a diagnosis of axillary nerve  injury.    See continuation page
facial paralysis, increasing severity post onset...1/20/2010 recieved medical treatment...diagnosis of Bell's Palsy...Palsy resolved over next 2-3 months...90%+ recovery...lay person cannot tell Palsy was present but Doctor can.
Information has been received from an office manager concerning a 14 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil. On 19-AUG-2007 "the patient developed shingles". The patient contacted the physician by phone call. At the time of the report the patient's outcome was unknown. Additional information has been requested.
New onset syncopal episodes secondary to new onset sustained polymorphic ventricular tachycardia and new onset orthostatic hypotension.  Episodes started 2 weeks after 2nd Pfizer COVID vaccine.  Had multiple pre-syncopal and syncopal events leading to 2 E visits and 2 overnight hospital stays.  Required AICD placement and oral pressor medications.
1st child recv vax & 48hr later 2nd child (sibling) devel fever & diarrhea;
Patient received Pfizer vaccine for 6m- 4 years instead of Pfizer vaccine 5 years-11years old.
Received SHINGRIX vaccination on April 28/2018. Developed severe LEFT Deltoid Pain with Markedly decreased ROM x 4 days. 2 weeks post injection developed deep ache in LEFT Upper Arm with severe paresthesiae starting in upper arm radiating mostly into LEFT 4th and 5th fingers but also index and first finger. Responded to very small doses of Prednisone but pain came back after day or 2 and has persisted till now. Routine lab work including ESR, CRP, Sugar, etc. have been normal. Neurology was consulted and confirmed Brachial Plexopathy LEFT Arm, with weakness in Ulnar distribution milder median nerve distribution. EMG confirmed this. MRI C-spine DDD but no acute findings. MRI Brachial plexus Negative. Diagnosis is Post Injection Zoster Neuralgia. Review of available literature: I cannot find anything related to this but Pain and Parethesiae are severe and are same as Post Herpetic Neuralgia symptoms.
Tongue swollen then throat started closed up. Patient experienced symptoms within 20 minutes after the shot.  Patient took 3 tablets of bendaryl before going to ER.  In ER patient was given epi pen shot, IV (patient does not know what in the IV). Patient states to contact ER for more details
05/06 - some muscle pain and weakness  05/07 - severe persistant abdominal pain from 4:00 pm. Lost appetite. Weakness. 05/07- in the night went to ER
pt recv vax 21MAY97 & 22MAY97 pt exp viral illness & a fever of 104.2;pt temp was 103 on 23MAY97;30MAY97 pt devel bilat OM & tx w/sulfa;2JUN97 pt exp T104.7 & vomited;pt devel discrete papules on face & chest;
On 12/14/15 around 1:15 pm, 11V4, Hepatitis A, Tst were administered. On 12/17/15 pt. returned for TST reading and described the following: after apt. on 12/14/15 she experienced an achy right arm, headache and slight dizziness. The following morning on 12/15/15 her right arm was painful with swelling from vaccine site to ear with some arm/hand numbness. She also verbalized a tender (pea size) nodule on right side of neck. Currently pt. states neck/nodule is feeling better but still sore with some residue arm/hand numbness and continued headache and dizziness.