chrisvoncsefalvay/vaers-outcomes huggingface dataset:
still has arm discomfort from second shot.; Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.; felt lazy; she felt down the next day; did not want to do much; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (still has arm discomfort from second shot.), PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.), LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LANSOPRAZOLE (PREVACID), SIMVASTATIN and TROSPIUM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much). On an unknown date, the patient experienced LIMB DISCOMFORT (still has arm discomfort from second shot.) and PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.). At the time of the report, LIMB DISCOMFORT (still has arm discomfort from second shot.) and PAIN IN EXTREMITY (Arm is still sore when arm put across chest to touch the shoulder/Arm hurts two inches from the elbow up to the shoulder.) had not resolved and LAZINESS (felt lazy), FALL (she felt down the next day) and FATIGUE (did not want to do much) outcome was unknown.            Concomitant medication included Digestive probiotic.  Treatment information was not provided.   This case was linked to MOD-2021-403707 (Patient Link).
Shorty after first vaccine dose on 1/28/21, patient developed palpitations. She has continued to  experience intermittent dry cough, shortness of breath and palpitations since. She did receive the second dose of the covid vaccine 2/26/21 (Moderna, lot 013A21A, left deltoid)
1421: pt c/o itchy throat, right ear feeling "full" and feeling "warm". Pt appeared flushed. Benadryl 25mg given PO at 1424. Reassessed patient 1438, pt reports feeling less flushed but still has a scratchy throat and her ear still feels full.
Left upper extremity "cellulitis" began within 24hrs of vaccination. At time of presentation to ER on 4/12, patient was complaining of warm, erythema, tenderness. Soft tissue US showed soft tissue edema without distinct fluid collection. She was treated with Keflex 500mg Q6H x7 days starting 4/12.  Patient also had acute onset dyspnea on 4/12 associated with chest heaviness, which is what prompted her to go to the ER on 4/12. Troponins were neg x3 with no EKG changes, but she did have an AKI, which was treated with gentle IV fluids. LHC was offered during her hospitalization, but patient declined due to poor kidney function
Case was vaccinated x2 for Covid as of April 2021, then was hospitalized for Covid in September 2021. Hospitalized at:  a local Hospital .  Acute respiratory failure with hypoxia (HCC) Assessment & Plan Admitted with COVID-19 pna. Vaccinated. Mild acute respiratory failure with hypoxia with oxygen saturations in the high 80s and need for 2-3L nasal cannula oxygen. CTA consistent with GGO's, dx with pna. Mult RF - obesity, asthma, OSA but she did improve over the course of four days. Now on RA.  --cough pretty intense - did not respond well to tessalon pearls. Started mucinex. She prefers oxycodone for chest pain and cough so given 15 on d/c.  --continue tx for asthma with symbicort - likely acute exacerbation  --continue to encourage CPAP at night.  --Will finish 10 days of decadron. Finished three doses of remdesivir.  Pneumonia due to COVID-19 virus Assessment & Plan Main reason for admission, she is vaccinated. Hx of PE, provoked from surgery - she was treated with ppx lovenox.    -Dexamethasone for 10 days started on admission -remdesivir for 5 days started on 9/27 (held initially because case looked mild)
Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; Swelling on the left side of my face over my Jaw/My face was severely swollen and the swelling was going down into my neck on both sides/The swelling in my face and neck had returned; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201), via an unspecified route of administration at right arm at the age of 31-year-old on 13Feb2021 07:00 at single dose for Covid-19 immunisation. Medical history included allergies to Sulfa. There were no concomitant medications in two weeks or other vaccine in four weeks. On Monday 22Feb2021 06:00 AM, the patient woke up in the morning with swelling on the left side of his face over his Jaw. Throughout the day the swelling increased and began to swell on the right side as well. That evening he went to an urgent care and was prescribed an antibiotic. When he woke up in the morning of Tuesday the 23Feb2021 his face was severely swollen and the swelling was going down into his neck on both sides. He went to the emergency room (ER) and was admitted overnight. He was given intravenously (IV) antibiotics, steroids and fluids. All blood tests came back normal and negative(Feb2021). When the swelling went down considerably, he was discharged on Wednesday 24Feb2021 and sent home with a steroid and antibiotic to take orally. Upon waking up this morning, on 25Feb2021 the swelling in his face and neck had returned. Adverse events were resulted in emergency room/department or urgent care and hospitalization. There was no COVID prior vaccination. The COVID tested post vaccination. The patient underwent lab tests included nasal swab was negative on 23Feb2021. The outcome of events was not recovered.
made her sick; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as  2nd dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included pregabalin (LYRICA) for fibromyalgia. On an unspecified date, the patient stated that the 2nd vaccine shot made her sick and couldn't sleep. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
12/19/2021 - Pfizer vaccine received 12/20/2021 - received a call from the school nurse that the daughter presented with a fever of 100-101 and the student was sent home by the school nurse.  12/24/2021-12/25/2022 symptoms of fatigue, red rash, and fever of 101 F (parent thought it was a reaction to the vaccine, 1st dose) 12/29/2022 - Antigen Home Test administered by mom was positive, Subsequent SARS-Cov-2 (C-19)(RT-PCR) test administered by RPH resulted in "DETECTED." 1/09/2022 2nd dose Pfizer vaccine administered w/ no adverse effects. 3/25/2022 visit to urgent care for conjunctivitis (pink eye) Right Eye resulted in prescribed medication 4/8/2022 dry wet cough noted and lethargic during sports activity. 4/11/2022 Slight fever w/ progressive cough prompted an antigen home test positive for C-19.  Subsequent follow-up appt w/ pediatrician on 4/12/2022- Flu test was negative and PCR test administered by Pediatrician resulted in a positive "DETECTED" lab result.
(R) upper arm (injection site) is tender swollen with violaceous/erythematous patches. Induration.
Information has been received from a consumer concerning her 24 year old daughter with a history of reaction to erythromycin who on 05-FEB-2008 was vaccinated with the initial dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Shortly after receiving GARDASIL (approximately 05-FEB-20080 the patient became nauseous. The nausea subsided on 09-FEB-2008. On 10-FEB-2008 the patient developed hives. The physician was notified and BENADRYL was prescribed. BENADRYL helped initially but as of 18-FEB-2008, the hives persisted. The patient's mother indicated that the physician told the family he did not believe the hives were related to therapy with GARDASIL. Additional information has been requested.
Initial unsolicited report received from a pharmacist on 4 September 2015. This case involves a female patient [age not reported] who was vaccinated with an intramuscular first dose of H1N1 (dose, batch number, expiry date and site of administration were not reported), on an unspecified date in 2009. Illness at time of vaccination was unknown and preexisting physician diagnosed allergies included allergy to Amoxicillin. Concomitant medications was not reported. On an unspecified date in 2009, post vaccination, the patient experienced shortness of breath and swelling of the injection site. Laboratory data and corrective treatment was not reported. On an unspecified date, the patient recovered from the above mentioned events. List of documents held by sender: none.
One of the side effects is swelling at the site of the injection site, however it's been one week and it's still swollen; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE SWELLING (non-serious), outcome "unknown", described as "One of the side effects is swelling at the site of the injection site, however it's been one week and it's still swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a licensed practical nurse concerning a 16 month old male who on 16-MAR-2006, at 12 months of age, was vaccinated in the left thigh with a first 0.5 ml dose of Varivax (lot# 646816/0631R). Concomitant vaccination included a first doe of MMR II (lot# 650349/0969R) SC in the left thigh and a third dose of IPOL (lot# Y0824) SC in the right thigh. On 15-JUL-2006 the patient developed shingles which were reported to be at C-5, C-6, some on the upper right shoulder/scapula, antecubital fossa and wrist. There was no fever and a pain rating of 0 on a scale of 0 (least) to 10 (most). No other systemic symptoms were noted. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. Unspecified medical attention was sought. Subsequently the patient recovered on 23-JUL-2006. No further information was available. There was no product quality complaint involved. Additional information is not expected.
This case was reported by a pharmacist and described the occurrence of light headedness in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included dizziness, which the subject had experienced a few days prior to vaccination. On an unspecified date the subject received a dose of FLULAVAL (details unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced light headedness and broke out in sweat. At the time of reporting the outcome of the events was unspecified.
A patient was administered with a dose of PENTACEL vaccine without reconstituting with diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Agency (Reference number- 00784846) and transmitted to Sanofi on 24-Sep-2021.  This case involves a 4-month-old male patient who was administered with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without reconstituting with diluent (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 24-Sep-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6945AA, expiry: 09-Jul-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).  It was reported "Caller stating they administered a patient a dose of PENTACEL without reconstituting with diluent. Caller wanting to know if they can administer the diluent separately. Caller clarifies that the DAPTACEL/IPOL portion of the PENTACEL vaccine was administered, however they forgot to administer the powdered ACT-HIB portion. She asks what diluent can be used with the ACT-HIB portion of the PENTACEL vaccine so it can be administered."  No additional adverse event (AE) 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 the 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.
Non-Responder to 6 Doses of a Previous Hepatitis B Vaccine Responded to Heplisav Series; Initial Report Received on 08-Nov-2021.  Heplisav-B in prior hepatitis B vaccine nonresponders: a case series.  24 September 2021.  In a case series by (2021), patients with documentation of 6 doses of a standard hepatitis B vaccine, received 2 doses of Heplisav-B, and the results of post-vaccination tests were collected from existing health records within the system.    Patient ID 4 received an initial hepatitis B series at 47-years-old and a second hepatitis B series at 48-years-old.   A total of 6 doses of the standard hepatitis B vaccine were administered. The patient was considered a non-responder.  At 51-years-old, the patient received the initial dose of Heplisav-B.   The patient completed the Heplisav-B series (details not specified).   On an unspecified date, at least 1 month after completing the Heplisav-B series, the hepatitis B surface antibody was positive.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Menstrual cycles since vaccination have been off after being very regular for a very long time.  They have gone from being 2 weeks early to up to 2 weeks late.  Some periods are heavier and some might only be for a day.  Cramps have been more severe and have lasted longer than the actual period.
TINGLING AND NUMBNESS IN FINGERS AND TOES, LIPS STARTED TINGLING AT 5:30, RED, AND WARM LIPS
Information has been received through a pregnancy registry from a 26 year old Caucasian female consumer with no past medical history and NKDA. On 07/12/01 and 08/15/01, the pt was vaccinated with the first and second dose of varicella virus vaccine live (site unknown) (0.5 ml). Concomitant medications included albuterol (17 g) sporadically. On 08/15/01, the pt had inflammation, redness and soreness at injection site for 24-36 hrs. On 09/04/01, the pt found out that she was pregnant (LMP) 08/15/01). The pt began treatment with amoxicillin trihydrate (Trimox) (500 mg) (21 doses) from 08/27/01 to09/03/01. The pt sought unspecified medical attention. Additional information has been requested.
Significant pain at injection site, within hours of injection.  Appr. 3 1/2 days later, intense pain involving entire shoulder girdle,  lower neck, and upper thorax, bilaterally, anterior and posterior, most pronounced in substernal area in vicinity of manubrium.  The pain awakened me from sleep, and was excruciating (I have a high pain threshold), preventing sleep the rest of the night and following day.  It was pleuritic in nature, clearly worsened by deep inspiration, and was unremitting.  Headache, slight fever, and chills developed subsequently, prior to abrupt resolution of symptoms 25 hours after onset, leaving only slight residual dull pain, which gradually disappeared over the ensuing two days.    I have never before experienced any reaction whatever to the flu vaccine.
Pt Developed a right upper extremity tremor sites after administration of vaccines persists at 48 hrs. No other neurological findings.  5/14/09 Received vaccine & PCP medical records of 5/8/09. FINAL DX: none provided Records reveal patient experienced shaking of RUE since vaccination.  Neuro exam WNL although tremor persisted throughout exam.  ID & Neuro phone consults done.  Continued observation, no tx or labs.
I had a fever, chills, body aches, and fatigue. I also had weakness, shortness of breath, and serve dizziness. They symptoms lasted about 36 hours. They were so severe that I could not leave the house. I even had to call off work. I did follow up a few months later for fatigue, weakness and joint. They did test blood work. I had severed arm pain that I could not lay on my arm for 3 weeks.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 58 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
On the 21st of December that evening is when I noticed I was getting dizzy spells. I kind of shook it off as I stood up too fast. On the morning of the 22nd there was a ringing in my left ear like a static sound. I shook it off as nothing as well because I thought I slept on it wrong. 11:30 in the morning is when the world starting spinning for me fast and I started stumbling and getting sick to my stomach. That lasted probably a good 3-4 hours and then around 4:15 is when I was able to get in the urgent care for them to see me. They were able to diagnose me with Vertigo and prescribe me medication. They prescribe me meclizine.
Chills that started at 12mn of Aug. 14, 2021, Fever, headache, body aches, diarrhea, all throughout August 14, 2021 that subsides on August 15, 2021 6:00PM
Patient is a 59 y.o. male with schizophrenia, anxiety, HLD, CKD, DM, hypothyroidism, and hx of CVA.  He presents as a transfer after being found to have COVID19 at his group home.  He is not able to provide any hx surrounding his current state due to cognitive dysfunction and underlying mental health issues in addition to prior CVA.  Apparently the group home sent him to the ER due to poor oral intake for the past couple days.  He has also been lethargic.  NO other reports of fevers or chills.  He had a + contact from one of the staff at the group home.
COVID 19 TEST POSITIVE; This spontaneous report received from a patient 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 previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, (dose number in series 1), 01 in total administered, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, (dose number in series 2), 01 in total administered, 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 following administration of covid-19 vaccine ad26.cov2.s, the patient tested positive for Covid-19 at home on a rapid antigen test one month after getting his booster dose (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was unknown (dose number in series 2). This report was non-serious. This report is associated with a product quality complaint (PQC) number: 90000210253. The suspected product quality complaint has been confirmed to be voided. This case does not qualify for a PQC since the only indication is that the patient had Covid but does not refer to any symptoms based on the PQC evaluation/investigation performed.; Sender's Comments: V0:  Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
swollen glands/lymph nodes on the left side of the neck(BEHIND EAR)  and head.  painful
I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/10/2021 ALTERED MENTAL STATUS, UNSPECIFIED I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/10/2021 HEMATURIA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/10/2021 UTI (URINARY TRACT INFECTION)
On 4/27/01, injection site was red, swollen and painful. Increased swelling and redness on 4/28/01 and went to ER. Dx'd with aseptic abscess. Rx'd with ibuprofen and cold packs. Seen at MD on 4/30/01 and was beginning to resolve. Rx continues. 1/2" needle used for administration of vaccine. Is recovering.
Urticarial rash started 2 days after injections. Itchy hands for 1 week.