chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard time getting out of the bed; Hard time walking; Hard time to sleep; Intense body aches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Hard time getting out of the bed), GAIT DISTURBANCE (Hard time walking), INSOMNIA (Hard time to sleep), MYALGIA (Intense body aches) and ARTHRALGIA (Joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H216, 026A21A and 026M21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Hard time getting out of the bed), GAIT DISTURBANCE (Hard time walking), INSOMNIA (Hard time to sleep), MYALGIA (Intense body aches) and ARTHRALGIA (Joint pain). At the time of the report, DISCOMFORT (Hard time getting out of the bed), GAIT DISTURBANCE (Hard time walking), INSOMNIA (Hard time to sleep), MYALGIA (Intense body aches) and ARTHRALGIA (Joint pain) was resolving.            No Concomitant product use was reported. No treatment information was provided.  The reporter was reporting adverse event on the behalf of themselves and their husband who was the patient. The patient after getting the booster started to experience intense body aches, joint pain, hard time getting out of the bed, hard time walking and hard time to sleep. The reporter stated that overall symptoms were improving. The reporter also reported elevated liver enzymes.   This case was linked to MOD-2021-406429 (Patient Link).
Lymphatic response.  Severely enlarged lymph node on left collar bone with inflammation spreading all the way down to the underarm.
8/23/2011 -> Hep A #1 given - BP decreased, nausea - > resolved after G'ade/ 8/27/2012 -> Hep A #2 given - syncope, head bang on floor, BP ok but weak, at 1229, nauseated - > in atrial flutter lasting for > 1 hour. CT - minor or arachnoid cyst. Cardiac evaluation - normal neuro eval - normal >> allergic reaction.
Arm pain; swollen and tender supraclavicular lymph node (injection side); swollen and tender supraclavicular lymph node (injection side); general fatigue; sinus congestion; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), with the first dose on 15Dec2020 and second dose on 05Jan2021; both intramuscular in the left arm at a single dose for COVID-19 immunization. The patient's medical history included penicillin allergy and lactose allergy. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Jan2021, the patient experienced arm pain, swollen and tender supraclavicular lymph node (injection side), general fatigue, and sinus congestion. No treatment was received for the adverse events. Outcome of the events was not recovered. The events were considered non-serious by the reporter.  Information on the lot/batch number has been requested.
Rheumatoid arthritis flare up in left shoulder; Spinal cord injury; Neurogenic bladder; Right foot with neuropathy, Neuropathy of right foot; Area periodically develope warts; Bladder infection; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder), SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection, Urostomy and Catheter placement. Concurrent medical conditions included Foot infection (with Humira) since February 2021, Sulfonamide allergy and Latex allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, METHOTREXATE for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) (seriousness criterion medically significant), SPINAL CORD INJURY (Spinal cord injury) (seriousness criterion medically significant), NEUROGENIC BLADDER (Neurogenic bladder) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot) (seriousness criterion medically significant), SKIN PAPILLOMA (Area periodically develope warts) (seriousness criterion medically significant) and CYSTITIS (Bladder infection) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) was resolving and SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient experienced bladder infection in 2021.  The patient was treated with Nitrofurantoin started approximately on 01 Mar 2021.  Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.
This spontaneous prospective pregnancy report as received from registered nurse refers to a 25 year old pregnant female patient with Last Menstrual Period (LMP) of 10-NOV-2015. The patient presented no pertinent medical history or drug allergies/reactions additionally, no concomitant medications were reported. On 06-JAN-2016 the patient was 8 weeks pregnant, first trimester when she was vaccinated with the second dose of GARADASIL 9 (lot # L028083 with expiry date 03-SEP-2017) (strength, dose, anatomical site and route were not reported). The patient did not seek any medical attention and none diagnostic studies were performed. Estimated Delivery Date (EDD) reported as 16-AUG-2016, however, it was unknown whether the patients were pregnant on the time of reporting. Additional information has been requested.
This spontaneous report was received from a physician refers his aunt of unknown age, who on an unknown date, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that "as of the last several weeks of month" on an unknown date, his aunt developed shingles. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for patient had developed shingles was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Fell and broke shoulder; Fall; missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of UPPER LIMB FRACTURE (Fell and broke shoulder) and FALL (Fall) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UPPER LIMB FRACTURE (Fell and broke shoulder) (seriousness criteria disability and medically significant), FALL (Fall) (seriousness criteria disability and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine). At the time of the report, UPPER LIMB FRACTURE (Fell and broke shoulder) and FALL (Fall) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications and medical history were not provided. Limited information was available as the called hung-up.  Very limited information regarding these events has been provided at this time. A causal relationship cannot be established.; Sender's Comments: Very limited information regarding these events has been provided at this time. A causal relationship cannot be established.
pt recv vax 15SEP95 & 5DEC95 pt devel chicken pox w/20-25 lesions;pt did not exp fever;no further details were provided;
Left shoulder, Intense should pain started hours after administration.  Limited range of motion.  Pain is constant, worse with certain movement numbness and tingling down to elbow
INCAPACITATED; NEUROLOGICAL ISSUES; CARDIO ISSUES; GASTRO ISSUES; OTHER ISSUES; This spontaneous report received from a patient concerned of unspecified age, sex, ethnic origin and race. 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, batch number and expiry were not reported) dose was not reported, 1 total administered on 27-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  From an unspecified date, the patient had been incapacitated (Disability NOS). The patient experienced neurological issues (Neurological disorder NOS), cardio issues (Cardiac disorder), gastro issues (Gastrointestinal disorder) and other issues (Adverse event NOS) which was attacking all of the organs. The patient wanted a way to detox the spike proteins or some other way to remove this out of the system before it became life threatening. Patient was desperate and was asking for help. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from incapacitated, neurological issues, cardio issues, gastro issues and other issues. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211018778-covid-19 vaccine ad26.cov2.s- incapacitated. 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).
BAD CRAMPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-APR-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 experienced cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps. This report was non-serious.
Narrative:  Patient is a 55yo FEMALE with PMH significant for breast cancer, hypothyroidism, and PTSD. In addition, patient with significant adverse reaction/allergy history. Causative agents include medications (e.g., penicillin [rash], codeine [N/V, rash], acyclovir [anaphylaxis], valacyclovir [rash, angioedema] and non-medication triggers (e.g., gluten [anaphylaxis], wasp venom [anaphylaxis], bee pollen [anaphylaxis], contrast media [swelling]). Per 2/23/21 Clinic Video Visit note, patient received the first dose of the Pfizer COVID-19 vaccine on 1/7/21 at a outside facility. Patient had a delayed allergic reaction involving hives, hypotension, and tachycardia. The reaction may have been delayed due to patient pre-medicating with diphenhydramine prior to receiving the vaccine. Patient elected to not have the second dose of the vaccine and may reconsider in the future. No further notes documenting further adverse effects from the vaccine.
fatigue; chills; headache; very heavy/dead legs; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, chills, headache, and very heavy/dead legs. The outcome for all the events was unknown.  Information about lot/ batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Within 1 hour of injection pt has had pain at injection site and radiate down the arm. It is constant pain and occasionally demesnes range of motion to worse cannot raise arm above shoulder Has tried: Tylenol, Ibuprofen, Vicodin, Aspercream, Icy Hot, Activon, healthy Pad with no relief.
Accidentally Gave a Pregnant Woman a HEPLISAV-B Vaccine; Accidentally Gave a Pregnant Woman a HEPLISAV-B Vaccine; Initial report received on 31-May-2023.  A healthcare professional reported that a 28-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and that the patient is pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date (approximate date of Apr-2023), the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported) from a pharmacist.   On an unspecified date, after having been vaccinated with HEPLISAV-B, the patient was noted to having been pregnant. The event outcome was not reported.  No additional information was reported.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recvd vax on 5MAY93 & that evening pt exp a dermatologic react manifested by large ecchymotic areas w/swelling & itchiness from pts shoulder to elbow; The sx subsequently resolved; No further details were provided;
83F w/ PMH of HTN, HLD, palptiations, presents w/ several days of bilateral LE pain/numbness/weakness.   Patient woke up on 8/3 AM w/ severe pain in her hips shooting down the legs, first on the right then the left. She went to her PCP who prescribed her naproxen/cyclobenzaprine. By the time she arrived home, she was unable to get out of the car due to significant weakness. On 8/5, she start to develop urinary incontinence. Denies any falls or trauma. Of note, patient received Pfizer vaccine 1st dose 7/8 and 2nd dose on 7/29. Denies any history of autoimmune disease or FH of autoimmune disease. No recent viral like symptoms. No sick contacts.  Impression: Paraparesis + urinary continence likely secondary to longitudinally extensive transverse myelitis spanning the distal thoracic level (T11) to the conus. Etiology uncertain, but possibly vaccine related myelitis. The hyporeflexia in her LE are discrepant from a myelopathy, though this could be due to conus involvement (UMN/LMN signs) or age-related. I doubt this is an AIDP given the radiographic findings but CSF analysis will clarify this.
Pins and needles in hands and feet.  Palms of both hands turned dark red.   Vaccinated arm (left arm) extreme pain and restriction up to my shoulder, neck and upper back.  Burning pain.  Flush.  Fifty four days later still experiencing  pins and needles, dark red palms off and on, and flush.  All of these symptoms started immediately after getting covid 19 Pfizer vaccine.  No treatment just suffering.
I began to feel nauseous and lightheaded while brushing my teeth around 10:30 pm several hours after I received the first injection of the Moderna COVID vaccination. I sat down and started feeling very hot. I passed out a few moments later. I woke a few minutes or seconds after passing out and was evaluated by EMTs. They said my vitals looked good, but strongly recommended I go to the emergency room for further evaluation. The ER performed and EKG and bloodwork, both of which were normal. I was told this was most likely vasovagal syncope and sent home. I have had a previous history of fainting from injury or injections. This was different because the fainting has previously occurred minutes or seconds after the triggering event versus hours. Since that night, I've  been tired and experienced occasional lightheadedness. I saw my primary care doctor today (4/21) and he advised me to fill out this report.
Pentacel Vaccine was given to patient on 09/09/19 however, Pentacel was not reconstituted to include HIB. Patient has no signs and symptoms of an adverse event but this is considered an error. Outcome is that we are contacting mom to give HIB portion of vaccine separately.
Pain at injection site, swelling, parasthesia, fever/chills, fatigue - all lasting for 5-7 days.
Information has been received from a health professional concerning a 5 year old male who, "last week," in April 2007, was vaccinated with a 0.5 ml subcutaneous dose of ProQuad. "Last week," in April 2007, the patient developed a rash on her right arm, 4 by 3 inches, at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 13 month old female patient with no medical history or no known allergies who on 22-Apr-2004 was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # not reported). On 29-Apr-2004 the patient presented to the physician office with a rash on her face, pink skin and a fever of 102 which started 3 days prior. Treatment with diphenhydramine hydrochloride (BENADRYL) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) anti-itch bath was recommended. At the time of the report the patient had not yet recovered.  Additional information has been requested.
10 minutes after dose #2: Mild Facial flushing, parasthesias in bilateral fingers, mild lightheadedness. Observation only
Patient received tetanus toxoid vaccine (Td) on 5/19/03. Developed warmth and erythema on 5/20/03 which progressed with the development of vesicular lesions. Admitted to hospital on 5/21/03 started on antibiotics and systemic antihistamines.
This spontaneous report as received from a Nurse refers to unspecified patients of unknown age and gender. On an unknown date in 2014 (also reported as since 2014) the patient was vaccinated with PEDVAXHIB (lot number and expiry date unknown) (dosing regimen and frequency unknown) which was exposed to temperatures below the recommended range. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PEDVAXHIB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PEDVAXHIB was unknown. No product quality issue was reported. This is one of the two reports from the same source. Additional information has been requested.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medication were reported.  No Treatment information was reported.
Received GARDASIL and FLUZONE on 3/14/16. Woke up (on vacation) 3/28/16 with right sided facial paralysis. Seen locally by MD on 3/29/16 and diagnosed with Bells' Palsy - no treatment. Mom called our office 3/30/16 and put on PO steroids.
Received vaccination 4/15/11 at approx 8:45 am. By 2 pm that day, had developed severe pain at injection site. By 9 pm had very severe pain in upper arm that prevented moving arm. Slowly improved over next 48 hours.
severe pain at injection site; shallow breathing; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: E13302), via an unspecified route of administration, administered in left arm on 10Feb2021 at 10:00 (at the age of 65-years-old) as single dose for COVID-19 immunisation. The facility type vaccine was hospital. The patient did not received other vaccine in four weeks. Medical history included cancer, COPD and penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin and gabapentin, all taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced severe pain at injection site and shallow breathing. The patient did not receive treatment for events. The outcome of events was not recovered.
Fever max 104.7, not below 102.1 for over 24 hours with OTC fever reducers.  HR 125-135 for >24 hours, chills, fatigue, dizziness
Dose 1 Moderna 02/09/2021 no lot #  Patient died of pneumonia, ARDS on 8/18/2021-not a covid infection, not vaccine related
Pts leg was very swollen, warm to the touch and had a slight rash near injection site.
The pt developed a large local reaction at the site of the DPT, requiring about 2 weeks for full resolution. This was the pts 5th DPT.
upper left arm red; rash on upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper left arm red) and RASH (rash on upper left arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (upper left arm red) and RASH (rash on upper left arm). At the time of the report, ERYTHEMA (upper left arm red) and RASH (rash on upper left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
pt recvd Hep B vax on 1st dose of FEB92 w/no adverse reaction; Pt recvd 2nd dose Hep B vax 2MAR92 & w/in 24 hrs devel major hives; 17MAR92 woke up puffy eyes; another day woke up w/puffy lips;