chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 17-DEC-2015 at 10:54, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 7.6 and 5.1 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the parent.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Feb2022, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) between 4'4" and 4'6", notes: her son is between 4'4" and 4'6"; SARS-CoV-2 test: (10Feb2022) positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe injection site reaction, chills/fever, severe headache up back of the head, aches/pains, nausea, itching entire arm of injection.  Unable to work for 2 days.  The was the second injection.
Red sore and swollen left arm area reported to ES on 11/21/01. Treated for cellulitis left arm within  hours after 500 mg by mouth. Cold at forearm 11/27/01 pt reports finished medication and No problems.
INSOMNIA W SLEEP APNEA 11/30/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Red, swollen, warm to touch at injection site 3-4 inches in circ. Advised Motrin-cool compress.
Racing heartbeat, extra heartbeats noted one week post injection. Cardiology Department placed a ZioPatch 14 day heart monitor on 02/16/2021. MD reviewed ZioPatch results and made diagnosis of Trigeminy on 03/11/2021. No treatment given and symptoms continue.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot #, expiration date and dose not reported) orally. The doses of vaccine were improperly stored at 8.5 degree Celsius for 1 hour. Data logger was involved. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
Information has been received from a third party claims administer, concerning a male who on 14-OCT-2013, was vaccinated with a dose of PNEUMOVAX23 (lot # J004747 expiration date 21JAN2013). The patient sustained an adverse reaction. It was unknown if the patient sought medical attention. At the time of this reporting, the outcome was unknown. Additional information has been requested.
Severe lower back and hip pain on left side, feels like spasms and electric shocks. Also lower abdomen pain (feels like bad menstrual cramps).
body aches, headache, chills, nausea, unable to do daily activities, missed work
PT WITH HISTORY OF NON SPECIFIC HEADACHES FOR PAST 10 YEARS, WAS SEVEN DAYS POST SMALLPOX VACCINE ADMINISTRATION (VACCINE GIVEN 02 APRIL 03) WHEN HE DEVELOPED HEADACHE AND TRANSIENT R SIDED VISUAL DEFECT THAT LASTED 20 MINUTES. THOUGHT TO BE SECONDARY TO MIGRAINES AFTER THUROUGH  EVAL BY NEURO AND ID, PT REQUIRED HOSPITALIZATION FOR FULL EVEALUATION
Constant low level ringing in ears (tinnitus), sometimes gets a little louder but then decreases back to the low level.
I developed calcific tendinitis in my left shoulder.   I saw orthopedic surgeon, on 6/15/22.  He diagnosed me after taking an X-Ray that showed calcific changes in my tendon.  I was treated with two steroid shots and received PT.
On Saturday afternoon, I began to experience chest pain, and the nerves in my arms and legs felt like they were rubber bands pulled tight, and someone flicked them.  This is typical s/s of my anxiety attacks, my Klonopin was not addressing the s/s.  I contacted practicing Psychology doctor, who prescribes my meds for mental health.  Because I was unable to see him in person he said it seems like you are having a strong immune response.   I continued to have increased episodes of the s/s, but I have been able to return to work.  This same thing happened last year when I received my Influenza vaccine.
Heart is racing all day. 144/82; Heart is racing all day. 144/82; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration on 23Feb2021 at 14:00 (at age of 49-year-old), as dose 1, single in left arm for COVID-19 Immunization. Patient's medical history includes Penicillin allergy. Concomitant medications include omega-3-acid ethyl ester (LOVAZA); Atorvastatin; and ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, 1 day and 10 hours after vaccination, patient's heart was racing all day 144/82. Patient received treatment for event with beta blocker Metoprolol. Patient had to visit health professional office due to events. The patient underwent lab tests and procedures performed on 25Feb2021 included blood pressure measurement: 144/82, increased; and heart rate: increases. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Ear Infections, Not Feeding, Vomiting, Fussy, Fever, Not Sleeping, Self Injurious, Hurting others, PICA, Fluid Behind ears, Vesicoureteral Reflux ( VUR ), GERD,  Autism, ENCEPHALOPATHY, Cannot tolerate Lactose, Cannot tolerate phenol foods like Almonds, Very Hyperactive, Developmental stage of a 1 yr old child, Cannot do any self care, Needs 24 hour care.
fever, chills, dizziness for the last 2 days, swollen lymph node on left side of neck near collar bone, mild swelling at injection site and itching.
First night (4/6/2022), could  not sleep more than an hour at a time due waking up to readjust position because of the pain. Day one after vaccination (4/7), sore arm and low grade fever. Second night after vaccination (4/7), waking up every two hours to readjust position. Day two after vaccination (4/8), rash erupted on right upper thigh, abdomen, and then my left wrist. Spent day in bed Third night after vaccination (4/8), only woke up twice from pain Day three after vaccination (4/9), rash has spread to right forearm Fourth night after vaccination (4/9), was able to sleep through the night without pain Day four after vaccination (4/10), hot, swollen, rash appeared on left upper arm centimeters below vaccination site  Was limited in amount of Benadryl I could take because I was driving a lot, and I rarely take pain killers unless the pain is bad. I probably only took one ibuprofen a day, and most of the pain was while I was trying to sleep.
A 35 year old male patient (CC) developed blisters on the left side of his forehead and pea sized lymph node in from of his left ear and neck after receiving his fifth dose of RabAvert on 06/07/04. The patient incurred a cat bite on his left leg. The patient received the post exposure series at the local health department. On the day of his fifth and last immunization on 06/07/04, the patient developed some itchy blisters on the left side of his forehead and a pea sized lymph node in front of his left ear and neck. Reportedly, he had no fever, nausea, malaise or other symptoms and no known allergies to the components if RabAvert. The physician assessed the events as related to the drug. Follow up received 06/25/04: Per reporter, date of birth is 09/28/1968. The patient began the RabAvert series in May. New events mentioned were itch and burns and were treated with Benadryl (25 mg three times per day as needed), and hydrocortisone cream. Lab work was drawn and results remain undisclosed. The patient did not return for additional follow up. Lot numbers and expiration dates unavailable.
Mom came to WIC clinic 26MAy92 to get vax & stated on 24MAR92 3-4 hrs p/vax pt vomited & had fever of 103; fever unable to be brought down & vomited several x's; Taken to ER for eval fever came down there but was there several hrs;
Information has been received from a nurse practitioner concerning a 23 year old female patient with no pertinent medical history and no known drug allergies, who on 21-NOV-2008 was vaccinated with the first dose of GARDASIL vaccine (lot # 661530/0575X) 0.5 ml intramuscularly. There was no concomitant medication. The patient experienced puss-filled boils around the site of injection (2008). The boils "come and go" for the last eight weeks. She had had a total of 8-10 boils so far. The patient had a tattoo on her left arm (around the deltoid area) which she had had for years prior to receiving the vaccine. The patient's puss-filled boils around the site of injection persisted. The patient sought medical attention. Additional information has been requested.
Sore shoulder muscle, limited arm movement, hard to raise left arm over head. Possible rotator cuff injury or bursitis.
I though I had an allergy flare-up. My doctor thought it was a combining of allergies, and just having Covid. Itching and running eyes. My face stayed wet.  Congestion and sneezing, left eye and nasal drip. This lasted for probably three and a half days after the prednisone kicked in.
Approximately 2 weeks after my 4th dose I contracted COVID and had the following symptoms: Cough, Itchy/scratchy throat, Fatigue, Cold-like symptoms, Difficulty breathing. I also passed out and was brought to the Emergency Room and while I was there - they ran some tests (including COVID) and it came back positive. They prescribed me with Mucinex and Albuterol Inhaler and was also advised to do a little bit of movement exercises. As of today 05/17/2022 my symptoms have improved and I started feeling better.
Dizziness  Flush Difficulty breathing (heavy lungs) Occurred about 5 minutes after injection
Vomiting and nausea occured the following morning after receiving the shot. I do not usually vomit.
Had 5 seizures, beginning about 23:00 on 10/13/00, ending at 09:00 on 10/14/00. Pt was unresponsive at those times. Tonic/clonic movements about 1 minute. Temperature 100.2F (axilla) in office at 10:40 on 10/14/00. Exam was normal except for mild rhinorrhea and elevated temperature. Dx: (1) febrile seizure and (2) viral illness versus IZ reaction. EEG scheduled for 11/1/00. The parent did not keep appointment for EEG and has not, as yet, rescheduled.
From initial information received on 14/Jan/2005 regarding an adverse event occurring in the USA, it was reported that two patients (no specified identification provided) received DAPTACEL, lot number C2131AA, on an unspecified data. The route and site of administration were not reported. An unspecified amount of time later, both patients experienced severe local reactions at the sites of injection. One of patients also experienced swelling of the entire limb. It was not reported whether either of the patients recovered from these events.
I had irritation from shoulder into ear. I had an earache so I visited my doctor. There appeared to be no infection.  After a couple of days it improved.
This case was reported by a healthcare professional and described the occurrence of pruritus of hand in a 58-year-old male subject who was vaccinated with BOOSTRIX and TWINRIX. Concurrent medications included Diovan and Tricor. On 19 April 2011 at 08:00 the subject received 1st dose of BOOSTRIX at 0.5 ml in the right arm and 1st dose of TWINRIX at 1.0 ml in the left arm. On 19 April 2011, 12 hours after vaccination with BOOSTRIX and TWINRIX, the subject experienced pruritus of both hands, burning of both hands and hand swelling in both hands. The subject was treated with Benadryl. At the time of reporting the events were unresolved. Follow-up information was received on 06 May 2011 from the reporting nurse. medical conditions included hypertension and dyslipidemia. The subject did not use alcohol or tobacco. The subject did not have any adverse events following previous vaccinations. End date for the events of pruritus of both hands, burning of both hands and hand swelling in both hands was 22 April 2011. on 19 April 2011, the subject experienced small blister lesions, several less than 0.5 cm, on the distal fingers of both hands. End date of the events was 22 April 2011. On an unspecified date, the subject experienced macular-type rash on his forearms and lower legs. Outcome was unspecified for all events. The nurse reported that the events were not associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medical product or any other known cause. The BOOSTRIX lot number was originally reported to be AC528068AA and was noted to be incorrect on 03 May 2011 and corrected to AC52B068AA.
1) on 05/08/21: Very fast irregular and hard hear beating for3 hours. 2) on 05/25/21: heart erratic and hard in morning for two hours 3) on 5/29/21: heart pounding hard, not erratic, from 4:30 am to 9:14 am 4) on 05/31/21: from 3:30 am to 10:30 am very hard hear beating. Ended on its own. 5) on 6/4/21: hard heart beats from 3:30 am to 4 pm.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions was not provided. On 31-DEC-2018, the patient was administered a dose of ZOSTAVAX (19400 PFU, lot # N026817 and expiration date 25-DEC-2018; frequency was unknown) with sterile diluent subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.
Pt developed dizziness about 3-4 minutes after vaccination.  Proceeded to start vomiting.  Vitals initially stable, however, pt became less alert, with rapid deterioration of status (BP 70/40, pulse 40's, sat 84% on RA).  EMS arrived and transported to hospital within 20 minutes of onset of symptoms.  Transported to Medical Center.
Small 8mm SQ nodule under skin still present today on 7/28/21. Not painful.  No erythema or warmth.
has had a fever "pretty much since".; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number, Expiry date was not reported) via an unspecified route of administration on 01Feb2021 as UNKNOWN, SINGLE for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. On 01Feb2021 (Monday, this week), the patient received vaccine and had a fever pretty much since. Patient had indicates she was 37 years of age with underlying health issues. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medial assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-MAY-2016, the patient was vaccinated with an expired dose of M-M-R II lot #K007106, expiration date 16-MAY-2016 (dose and route of administration were not reported). The vaccine did not undergo any previous temperature excursions. No adverse symptoms reported. Additional information has been requested.
I developed trigeminal neuralgia in November 2022. No idea if the adverse event was related to the vaccine
Pt developed a rash and was seen by physician, who described a vesicular eruption from midline of back, scattered across back, on dorsum of left arm, extending to the left hand. The pt was diagnosed with shingles zoster one day later. Pt was treated with Benadryl and Tylenol for itching/pain. Uncomplicated recovery. Pt never had chicken pox or any vesicular eruption prior to shingles.
Bell's palsy: patient woke up with one-side of face droopy and swollen. Called doctor. Rule-out stroke. They determined it was Bell's palsy. Given a steroid dose pack and Valtrex.
positive home ag 17Jan; positive home ag 17Jan; sx of nasal congestion 16Jan; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 52 year-old male patient received bnt162b2 (BNT162B2), administration date 16Nov2021 (Lot number: FF2589) at the age of 52 years 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 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 51 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 51 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Jan2022, outcome "unknown" and all described as "positive home ag 17Jan"; NASAL CONGESTION (non-serious) with onset 16Jan2022, outcome "unknown", described as "sx of nasal congestion 16Jan". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Jan2022) positive, notes: If COVID tested post vaccination: Yes, COVID test post vaccination: COVID test type post vaccination: Other, COVID test name post vaccination: Home Ag. It was unknown, the patient had other vaccine received in four weeks. It was unknown, If COVID prior vaccination. Patient was tested for covid post vaccination (Home Ag). It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, nasal congestion.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and VACCINATION FAILURE,  COVID-19, NASAL CONGESTION cannot be completely excluded.
Moderna COVID-19 Vaccine EUA Patient not 18 years of age; 17 years Identified during chart audits Community clinic
Patient was given the adult dose despite being only 10 years old. No adverse effects have been reported.
pt recv vax 23JAN96 & pt devel a local rxn to Typhoid characterized by a 10 x 3cm area of swelling, pain, & joint aches;tx w/Keftab & Decadron & recovered;
Information has been received from a registered nurse concerning a 15 year old female with penicillin allergy who on 26-JUL-2007 was vaccinated with the first dose of Gardasil (Lot #658094/0524U).  On 12-OCT-2007, she was vaccinated intramuscularly in unspecified deltoid muscle with the second dose of Gardasil (Lot #659435/1265U).  Concomitant therapy included influenza virus vaccine (unspecified).  On 12-OCT-2007, the patient fainted after receiving the second Gardasil vaccine.  On 30-OCT-2007, the patient was examined by the physician because of four more episodes of fainting (no previous history of fainting before the 12-OCT-2007 episode).  Laboratory work on 30-OCT-2007 for a complete blood count, iron level and a metabolic panel was within normal limits (levels unspecified).  An electrocardiogram did not show any abnormalities.  The patient's experience persisted.  Additional information has been requested.