chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US003633 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that the patient under 18-years of age was vaccinated with a dose of FLUCELVAV 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed form listed to unlisted and added second indication as "drug used in unapproved population".
felt fatigued; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and FATIGUE in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced HEADACHE. On an unknown date, the patient experienced FATIGUE. At the time of the report, HEADACHE and FATIGUE outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403180, MOD-2021-403107 (Patient Link).
sore arm; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 042L20A) for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sore arm was not resolved.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Task Force, after speaking with proper channels, decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
Information has been received from the authors of the published literature article. The authors enrolled participants from 12 of the original 15 communities in the 1981 immunogenicity study with a documented response to the primary plasma-derived hepatitis B vaccine series. Among the study participants at 30 years, they had 3 main groups: Group 1 comprised persons who did not participate in the 22-year study and therefore had no blood drawn at that time. An anti-HBs level >=10mIU/mL was considered protective. Study participants with anti-HBs levels<10mIU/mL were offered an intramuscular booster dose of 10 ug of RECOMBIVAX HB given to assess immune response to an antigenic challenge. The authors attempted to determine the concentration of anti-HBs 30 days after the boost (median interval between booster and follow-up blood collection, 33 days). A positive booster dose response was defined as anti-HBs levels >=10mIU/mL at 30 days after the boost. Among the 435 study participants, group 1: Comprised 243 persons who did not participate in the 22-year study and therefore had no blood drawn at that time. In group 1, among 118 eligible participants, 96 (81%) who had anti-HBs level <10 mIU/ml received a booster dose of RECOMBIVAX HB. The median age of the 85 persons from whom serum was obtained after the booster dose was 40 years; 47 (55%) were male. Among these 85 persons tested 30 days after the booster dose, 75 (88%) responded with anti-HBs level >=10mIU/mL; the GMC was 150.4 mIU/mL. Among the 243 group 1 participants, 125 (51%; 95% confidence interval, 47%-55%) had evidence of long-term protection from hepatitis B vaccination (defined by anti-HBs levels >=10 mIU/mL). Among the remaining 118 persons with anti-HBs levels <10 mIU/mL, 75 of 85 available participants (88%) who received a booster dose responded with anti-HBs levels >=10 mIU/mL. This case refers of the less 10 patients who after received a booster dose of RECOMBIVAX HB did not respond with anti-HBs levels >=10 mIU/mL. Among participants in group 1 with an anti-HBs level <10mIU/mL at 30 years, those with a higher pre-booster anti-HBs level were more likely to demonstrate a booster response (antiHBs>=10mIU/mL) than those with lower pre-boost anti-HBs levels. This suggests that even if the anti-HBs level at 30 years has waned to <10mIU/mL, the closer the level is to 10 mIU/mL, the higher the probability that the boost will succeed. This is one of two reports from the same literature source (linked to MARRS # 1608USA006624). Additional information has been requested.
The patient received COVID-19 booster vaccination few days ago but then suddenly developed flulike symptoms including fever myalgia lethargy headache decreased appetite and myalgia.  She also noticed pleuritic chest pain as well as shortness of breath as well as fever.  Her fever was as high as 104.   She had elevated cardiac biomarkers suggestive of myocarditis. She had the MAderna vaccination.
Was also feeling sick from that; flu-like symptoms; blood pressure varies/155/95 and 138/88; decreased appetite; Patient has also lost 8lbs; This is a spontaneous report from a contactable physician (patient) and a healthcare professional, based on information received by Pfizer(manufacturer control number: EC-2021-088083). This case refers to drug BNT162B2 and NORVASC (amlodipine besilate) for events Sickness, Flu-like symptoms and Blood pressure abnormal. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunization, amlodipine besilate (NORVASC), via an unspecified route of administration from Feb2021 at unknown dose for blood pressure, lenvatinib mesilate (LENVIMA) from 08Feb2021 to an unspecified date at 20 mg daily, from Feb2021 to an unspecified date at unknown dose, both via an unspecified route of administration for endometrial cancer (ICD C54.1). The patient's medical history included endometrial cancer (ICD C54.1). The concomitant medications were not reported. The patient's diagnosis was endometrial cancer (ICD C54.1). The patient was prescribed lenvatinib mesilate 20mg daily, start from 08Feb2021. Patient has also lost 8lbs since starting on lenvatinib mesilate, start Feb2021-unknown end date and had a decreased appetite, start Feb2021-unknown end date. Patient reported her blood pressure varies, and she was taking amlodipine besilate. Patient's readings was 155/95 and 138/88; patient was told to call her physician if it gets over 140/90, start Feb2021- unknown end date. The patient got her second COVID vaccine and was also feeling sick from that, flu-like symptoms but is getting better now which started Feb2021, (also reported as end Feb2021). The action taken in response to the event for products amlodipine besilate and lenvatinib mesylate was unknown. The outcome of event blood pressure varies, decreased appetite, patient has also lost 8lbs was unknown, outcome of the other events was recovering.   Information on the lot/batch number has been requested.
On 10-19-11 developed vomiting diagnosed with intussusception requiring surgery. On 11-2-11 again developed intussusception that resolved without surgery.
Patient had adverse reaction to HPV. She had headache and dizziness. Vitals was taken BP 118/68 RR16 temp 97.3 HR 66 oxygen 99% . Cold water was given and stabilized by Nurse. Discharged after 20 minutes with some instructions.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 1st dose of SHINGRIX. On 21st November 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient only had a sore arm about 4 hours after the vaccine and recovered. This case has been linked with case US2018225303, reported by the same reporter.
VERTIGO, DIZZINESS, MIGRAINE,NAUSEA 1 TO 2 TIMES PER DAY FOR THE LAST 5 DAYS, GOING TO SEE DOCTOR TODAY ABOUT SITUATION
Patient was hospitalized with COVID and is being treated with oxygen 2L nasal cannula and dexamethasone
My entire back felt like it had a sunburn. Sensitive and slightly painful when touched. Balance issues when walking or standing. Slight brain fog.
10cm x 6cm area on R deltoid with slight edema, erythema, warm to touch. No streaking. Neuro/vascular intact. Postive joint pain in R shoulder x 2 days (resolved today). No SOB.
After awakening at 11p.m.,  1a.m. , and 3:00a.m.   , I was off balance and found myself on the bathroom floor.  I must have passed out but don't remember how.  I had no injuries that I could see.  I lay there for a while.  I carefully got up and crawled back into my bed.   I lay there until about 6:00 a.m.  I again carefully arose, and I felt OK.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 at 10:00 AM as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 treatment started from 27Jul2022 and ended on 31Jul2022. There was no known allergies and no other medication in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. had her 1 yr immunization on 1/28/20. And came to clinic on 2/13/20 with red swollen eye with drainage and a rash. Provider feels it could be a adverse reaction to the MMR.  Rash and other nonspecific skin eruption (ICD-782.1) (ICD10-R21)    Assessment: mac red rash than blanches white on abd , chest and back; had MMR on Jan 28; will recheck on tuesday Eye drainage (ICD-379.93) (ICD10-H57.89)    Assessment: conjunctiva are clear; eyelids appear swollen with increased redness; had MMR Jan 28 so this could be the reaction we see to it ; will recheck Tuesday Pt. came to appt. on Thursday Feb 20th. No rash today no red swollen eye today either.
DULL PAIN TO MY HEART that lasted about 1 minute. Small bumps that appeared at various places on my body, itched, then disappeared. Tightness in my lungs that is still happening the next day, relieved by albuterol inhaler. Low grade fever and sweating. Soreness at site.
Patient called on 5/6/18 to let us know she had to go to the hospital due to infection from the vaccination. Swelling at the injection site, pain, and fever. Patient was given a course of antibiotics and pain killers.
Tiredness, fatigue; Sweaty; Rash on torso/upper thighs and chest; Body aches; Headaches; Freezing to death; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tiredness, fatigue), HYPERHIDROSIS (Sweaty), RASH (Rash on torso/upper thighs and chest) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included LOSARTAN, BISOPROLOL and MEXILETINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 08-Feb-2021, the patient experienced FATIGUE (Tiredness, fatigue), HYPERHIDROSIS (Sweaty), RASH (Rash on torso/upper thighs and chest), MYALGIA (Body aches), HEADACHE (Headaches) and FEELING COLD (Freezing to death). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore Arm), FATIGUE (Tiredness, fatigue), HYPERHIDROSIS (Sweaty), RASH (Rash on torso/upper thighs and chest), MYALGIA (Body aches), HEADACHE (Headaches) and FEELING COLD (Freezing to death) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called in stating that she received the first dose of the Moderna COVID-19 vaccine on 01Feb2021. Following the administration the patient experienced a sore arm. On 08Feb2021 the patient woke up and experienced tiredness, fatigue, sweaty, rash on torso/upper thighs and chest, body aches headaches and was "freezing to death". These side effects lasted for 7-10 days and are no longer present at this time.
Pt began to feel dizzy and nauseous.  Appeared diaphoretic.  BP was 111/75 pulse was 54.
This spontaneous report was received from a 59 year old male patient, reporting on himself. The patient's concurrent conditions included: "sugar", drug reactions/allergies included penicillin. Concomitant medication included Metformin. On 02-OCT-2018, the patient was vaccinated with PNEUMOVAX 23, route was reported as intramuscular or subcutaneous injection, for immunization for the prevention of pneumococcal disease (dosage information, anatomical site of vaccination and lot number were not informed). Concomitant therapies included Metformin. The patient reported that on 02-OCT-2018, when he got home "I had cold chills and hot flashes." He also reported that when he went to sleep he "sweated all night." Additionally, on 03-OCT-2018 (reported as today), he was experiencing "weakness in legs and hips, swelling and pain at injection site, and pain in back." It was also reported that treatment was not given for the adverse events. Laboratory diagnostics/studies were not performed. The patient sought medical attention calling his doctor. The outcome for all the events was reported as not recovered. The causality assessment between chills, back pain, injection site pain, injection site swelling, asthenia, muscular weakness, night sweats and hot flush and PNEUMOVAX 23)was not provided.
Received AVA while pregnant. Miscarriage 15 Dec 18. 9 Nov 18 - for new OB orientation.  G2P1 (aborta).  c/o nausea and poor appetite.  Denies vomiting. EDD by LMP 4 July 19 w/ LMP being 27 Sept 18, thus 6+1 weeks pregnant. 13 Nov 18 -  Urine cx shows GBS (10-50K)  and enterococcus faecalis (50-100K). Rx'd Amoxicillin 500mg po bid x 10 days.   Symptoms: OTH SPEC ABN UTERINE&VAG BLEED(N938).
Lethargy, headache, numbness in limbs, flu-like symptoms without fever, rash in same arm as injection, under original injection site appeared 6 days post vaccine. Rash was itchy, blotchy, warm but not infected. Rash resolved within 2 days of appearance. Doctor visit one week post vaccine to evaluate rash and previous symptoms. Lethargy, body aches, numbness lasted ~ 3 days post injection. Caused patient to miss work for 2 days. This was part 2 of 2 of the vaccine. Same symptoms occurred after part 1 of the vaccine on 06/03/16, but slightly less severe. Patient recovered after ~ 8 days post second part of vaccine.
Night 3 of vaccine woke  in am with right mild  thigh gnawing, a sensation never experienced before. Duration 1-2 hours. Night 4 woke 2 am with more intense discomfort left knee, again not like anything experienced before but did not require Tylenol. It was gnawing and annoying, Night 5 woke around 4 am with left lower leg/ side of foot mild ache which lasted a few hours. Stretching, changing positions had no effect on any of three nights.  Day after vaccine while exercising I perspired more than usual and was tired. Did not concern me in any way and would not have reported unless had above symptoms.  Question- Do any of the above symptoms indicate I should not get dose 2?  Thank you
tiredness the next day; flu symptoms; have dizziness like you know whenever my head down and get up you know I get dizzy.; It's like a vertigo.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown, Lot Number: Not Provided), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Not Provided), for COVID-19 immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Not Provided), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness the next day"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; DIZZINESS (non-serious), outcome "unknown", described as "have dizziness like you know whenever my head down and get up you know I get dizzy."; VERTIGO (non-serious), outcome "unknown", described as "It's like a vertigo.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx. 2 min. post injection, I saw her standing nearby me and she just went down onto the floor.  I caught her and she didn't hit head.  Had very brief seizure-like movement rt. arm &leg.  She then awoke and wanted to sit up.  Had circum-oral pallor, lasting 10-15 min.  911 was called.  She remembered me giving her a shot and she went to sleep, omly asking for a drink of water.  All this was least than a minute. Ambulance did take her to the E.R. and mother was called.  11/17/09 ED records received service date 11/12/09. Assessment: Syncope - vasovagal. Patient stated she was apprehensive, received vaccine at school, lost consciousness less than 10 seconds, brief right arm and right leg twitching. When she regained consciousness she was immediately alert and not confused. Presents at ED happy and alert. No other complaints.
Patient had low grade fever (99F) and swelling/redness/itching at site of injection.  Patient's daughter called back 11/18/19 to report these symptoms.  We advised to take Tylenol for fever & pain.  We followed up 11/19/19 and fever had resolved, but still having swelling/itching/redness.  Told to continue Tylenol & use ice pack for swelling.  Patient went to ER on 11/20/19 and received prescription for prednisone for swelling/itching.  MD told her this was an allergic reaction, but not anaphylactic.  She was told to get the vaccines in separate arms next time.
Stated felt dizzy after getting shot. Was told to sit down and was monitored. Pt stated arms felt tingly after a more minutes and then said she felt like she had difficulty breathing. Called 911 for ambulance
injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.
Pt recvd Hep B vax 15APR91 & on 16APR91 devel rash & exp generalized itching; next day exp severe pain in both arms, hips, & legs & had difficulty walking; Pt seen by MD on 18APR91 & given meds;
Exactly 1 week after injection, injection site (and only this area) became itchy, hive like bumps were present and then later that night, into following day (1/31/2021) it became red, swollen,  warm/hot to touch, and painful like a burn
Lymph node swelling  and pain in left arm pit 3? diameter bruise plus smaller bruise adjacent on left side of left breast - no pain or swelling.
On April 1,2021, patient experienced severe right arm pain up to right scapula & back, unable to move arm d/t pain & swelling, went to see provider, was sent & admitted to Hospital from 4/1-4/5/21. Diagnosed with RHABDOMYOSIS,
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/17/2022 OBSTRUCTIVE JAUNDICE  ACUTE DVT, UNSPECIFIED VEIN 5/27/2022 OBSTRUCTIVE JAUNDICE
Bell?s palsy. Started with pain in jaw and paralyzed right side of face a few days after pain began
I received the first dose of the Covid Moderna vaccine in my left arm on Tuesday (06Apr21).  On 07Apr21-08Apr21, I was slightly tired and had a slight pain in the left arm.  On 09Apr21 through 13Apr21, I had no issues, no pain and no tiredness.  On 14Apr21, a rash started to develop on my left arm at the injection site, the rash was red, painful and itchy.  By 16Apr21, the rash was a red oval shape that was approximately 3 and a 1/2 inches wide.  By 18Apr21, the rash, swelling, and pain went away.  No issues from 19Apr21 through 21Apr21.  On 22Apr21, the rash had returned and was now 6 inches wide, red and itchy.  The rash is not completely full, the area where the previous rash occurred was clear but a new oval rash grew around it.  This is now over three weeks since the first dose and I am still experiencing side affects
no issues immediately following vaccinations, next morning wokeup with redness at injection site and down arm to about her elbow, black and blue at injection site. was red and warm to the touch but not painful. patient iced arm and took tylenol, by the following morning (monday) the swelling went down alot but the black and blue spot at injection site remained