chrisvoncsefalvay/vaers-outcomes huggingface dataset:
decreased specific antibody response after immunization with Pneumovax; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 62-year-old female patient with chronic obstructive pulmonary disease (COPD). She developed four acute exacerbations of COPD (AECOPD) over the past year, manifested as acute worsening of cough, dyspnea, and sputum production. She required hospitalization three times and was treated with systemic glucocorticoids, antibiotics, and short-acting bronchodilators. Sputum culture on one occasion grew Streptococcus pneumoniae. She had two AECOPD treated the previous year with outpatient oral antibiotics. Chest CT during hospitalizations showed emphysematous changes without bronchiectasis. She had a remote history of pneumonia and three to four sinus infections, but no other history of recurrent or unusual infections. She smoked two packs per day (/d) for 25 years and stopped 5 years ago. Concomitant medications included high-dose inhaled corticosteroid (ICS), long-acting b-agonist (LABA), long-acting muscarinic antagonist (LAMA), roflumilast and azithromycin.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, strength, lot #, expiry date, site and route of administration were not provided) for prophylaxis. After immunization with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), she had a decreased specific antibody response, with two of 23 pneumococcal antibody levels above 1.3 microg/mL. On an unknown date, the immune workup demonstrated consistently decreased immunoglobulin G (IgG) of 340 (610-1500 mg/dL), immunoglobulin A (IgA) of 24 (80-450 mg/dL), and immunoglobulin M (IgM) of 42 (40-230 mg/dL), without systemic glucocorticoids. Lymphocyte immunophenotyping showed normal B-, T-, and natural killer cell subsets and normal switched memory B cells. The IgG levels to tetanus and diphtheria were in the protective range. She was given the diagnosis of common variable immune deficiency (CVID) and began 150 mg/kg weekly subcutaneous immunoglobulin therapy. Outcome of the event decreased specific antibody response was not reported.  The reporter considered decreased specific antibody response to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Literature Report  A copy of the published article is attached as further documentation of the patient's experience. This is one of 2 reports derived from the same literature article (cross referenced with MARRS #2207USA008796).; Sender's Comments:  US-009507513-2207USA008796:
Patient experienced subjective fevers 1 day s/p tetanus booster given.  Also with progressive area of surrounding erythema and induration.  At maximum, approximately 12 cm diameter erythema and 8 cm diameter induration surrounding site of injection.
Only shot in right leg was IPV. Pt's leg had bleeding after injection. Two weeks later, he developed a 2cm X 1cm hypo-pigmentated lesion, similar to a scar. Not evaluated. About the same, 6 weeks later.
PATIENT EXPERIENCED EXTEREME HEADACHES, NIGHT SWEATS, AND BODY ACHES. HE WAS SICK FOR 7 DAYS. HAD A LITTLE COUGH AND A 103 FEVER. GENERALLY FELT REALLY BAD. FIRST TWO SHOTS WERE NOT LIKE THIS. STARTED DAY AFTER SHOT. REPORTED ON 12/15/21 THAT HE STILL HAD SOME COUGH AND NIGHT SWEATS GOING ON.
Pain in muscle of upper arm and forearm; spread to general muscle aches over the rest of body, approx 10 days after getting shot. Now after 3 weeks, Pain is localized in upper arm muscle (took Advil)
TWO WEEKS AFTER INJECTION,: Very large red raised rash area extending up to shoulfer and approx. 5" around area.  Itchy, somewhat painful.
Vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Information has been received from an RN concerning an 83 year old female with allergies to sulfa and iodine and no other medical hx who on 30OCT2003 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination in the "other arm" included a dose of influenza virus vaccine. Concomitant medication included aspirin. The reporter indicated that the pt developed a reddened area around the injection site with edema. No treatment was required for the event. The reporter also noted that she was concerned about the lot number and has pulled the remaining vials in this lot from the stock. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The reporter also mentioned that two other female pts had similar reactions after therapy with  pneumococcal 23v polysaccharide vaccine and experience a similar reaction. Additional info has been requested.
Extreme swelling of upper lips and both cheeks. Steroid and PEPCID given. Observation for 2-4 hours in ER. Diagnose: angioedema (facial only). Steroid x7 day given with prescription for EPIPEN. 2 wks b/f edema had going down gradually.
Temp 99.7 left arm edematous, erythema, a slight raised wheal around site of injection left arm pain. Cellulitis was noted. 3 days after injection. Treated with Augmentin Susp 400mg / 5ml, 1 tsp BID x 10 days. symptoms resolved after treatment for 2 days.
This spontaneous report was received from a medical assisstant and refers to a 17 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-SEP-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot # M014929, expiration date unknown) for prophylaxis. On an unknown date (reported as after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The outcome of the events was reported as recovered on an unknown date in 2017. No treatment was given for the events. The causality between the events and GARDASIL 9 was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA012280: US-009507513-1710USA012278: US-009507513-1710USA012279:
Tinnitus. My tinnitus heightened right after the shot within about 5-10 minutes and stayed that way throughout the evening. This morning 4/19 at 5:30am I woke up to a clogged ear and tinnitus went from a 3 to a 9 in prominence. This has never happened before.
On morning of 6/6/17 while at school, pt. saw "colorful blasts" and then felt lightheaded. Headache then "wrapped around the front" of her head. Ice pack applied which helped and vision. TYLENOL administered by school nurse. Felt better but did vomit x1 around 11:30am. Now, in office at 3:00pm, patient feels "fine",
This spontaneous report was received from a medical assistant and refers to a 1 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided. On 22-JAN-2019, the patient was vaccinated with VARIVAX lot # R018780, expiration date 01-JUL-2020, 1 dosage form in the right thigh for and with PROQUAD lot # R020816, expiration date 16-JAN-2020, 1 dosage form in the left thigh (strength and route were not provided) both for prophylaxis. The vaccines were reconstituted with sterile diluent lot # R032351, expiration date 02-JUN-2021. No adverse effects reported.
Pt received pfizer vaccines on 03/01/21, 03/22/21, and 09/30/21. Pt presented to the ED on 12/11/21 with complains of falls and confusion. Pt was found to be COVID positive.
She had flushing on the same side of her face on that she got the vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 25Mar2021 08:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Mar2021 13:00 the patient experienced she had flushing on the same side of her face on that she got the vaccine. The outcome of the event flushing was recovering.  Information about lot/batch number not provided. Requested during follow up.
pt brought to ED via ambulance for AMC and worsening respiratory status; required intubation; positive for COVID; septic shock; pt passed away that same day in the hospital
11:30am- Vaccine Received.  6:00pm-body aches,  fever,  headache.  3:00am the following day- fever, body aches, skin hurting,  shivering,  headache,  malaise.  6:00am-bloody nose with giant blood clots that took me 20 to 25 minutes before it would stop.  The following 2-3 days still having ongoing fever and headache.
Severe swelling in left hand.  Soreness in left shoulder.  Head cold or head ache, with slight chills infrequently.
Chills, bones very achy and especially back.  Extremely tired.  Broke out in rash over whole body in about 27 hours after injection.
immed p/vax pt states arm felt tingly then became pale, diaphoretic, c/o difficulty breathing, tightness in throat did not lose consciousness or have cardiac or respiratory distress; pulse 84 strong, BP 80/40 - 118/60;
One day after Td vaccination suffered severe muscle pain in L arm R thigh Lateral neck muscle as well as muscle pain body wide. Gradually subsided over the next week.
Anaphylaxis lasted about until 8/18/2021 at 2:16 am. Back to normal except tongue a little swollen.
This spontaneous report was received from an approximately 66 year old female patient with arthritis regarding herself. The patient had no drug reactions or allergies. On an unknown date in March 2011, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). The patient was given pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) around the same time as the ZOSTAVAX (approximately in March 2011), but indicated that the vaccines were not given concomitantly. Concomitant therapy included LIPITOR. On an unknown date, the patient experienced a burning sensation in her joints shortly after receiving ZOSTAVAX, recommended by her primary care physician. She was treated with NEURONTIN by her rheumatologist which did not helped in her pain. On an unknown date in November or December 2012, her neurologist prescribed nortriptyline and her symptoms were reduced. On an unknown date in February (reported as February or March) 2012, and in the spring or summer of 2012, a physician tried treating the patient with OXYCONTIN, VOCODIN, TYLENOL with codeine, CYMBALTA and LYRICA (manufacturer unknown). None of these relieved the burning sensation, which kept her awake at night. A homeopathic practitioner diagnosed her with a possible allergic reaction to ZOSTAVAX. On an unknown date in March 2012, she stopped LIPITOR. On an unknown date electroencephalography (EEG) was performed and the result was unknown. On an unknown date, a  blood work was performed which indicated that she should go back on the LIPITOR. She stopped taking it for 4 days. She indicated that she thinks there may be a connection from when she was on LIPITOR and the severity of her burning sensation. She also stated that on Nortriptyline, she experienced dry mouth and weight gain. The patient had not recovered from neuropathy as none of the treatments relieved the symptoms. Outcome of other events was unknown. It was reported that the allergic reaction to be possibly related to ZOSTAVAX and the relatedness was unknown for pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). The relatedness for all the other events was unknown for ZOSTAVAX and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
flu-like symptoms : aches and pains and fever drinking lots of water and sleeping outcomes: still flu-like symptoms
aching lower back; freezing cold; could not lift her head; terrible chills; fever; laid out for a day/ in and out of bed all day; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm) and CHILLS (terrible chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day). At the time of the report, BACK PAIN (aching lower back), FEELING COLD (freezing cold), HEAD DISCOMFORT (could not lift her head), VACCINATION SITE PAIN (Sore arm), CHILLS (terrible chills), PYREXIA (fever) and FATIGUE (laid out for a day/ in and out of bed all day) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-069621 (E2B Linked Report). This case was linked to MOD-2021-069621 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069621:
pt recv vax last year OCT94 & devel swelling @ inj site;pt has recovered from the above rxn
Headache, Arthralgia, Fever, Tachypnea, Tachycardia, chills, lymphadenopathy Narrative:
Began loosing circulation in right pointer finger, began turning purple on 04/9/21 and on 04/10/21 spread through out the finger. I have pictures
I reported this to my doctor but he said I was a hysterical patient who bought into conspiracy theories. I do not. I am not anti vaccine. I was trying to share what happened. Within days of receiving my first covid vaccine I developed shingles. After the second I developed neuropathy. After the third the neuropathy became worse. I am young and healthy and this should not have happened. The neuropathy was improved because I resorted to natural remedies because my doctor again insisted I was being overly reactive. I wasn't. I needed help. I have used tumeric with success. I refuse to get any further covid vaccines as there was a direct correlation for me. I didn't say anything to any other doctor or person because that doctor made me feel ashamed. My friend in the drug industry encouraged me to submit this to the FDA as she said this is only how things get better for others.
Approx 6 minutes after administration, pt complained of left arm tingling into hand and fingers, left elbow sharp pains and feeling flushed. As assessing pt, then complained of chest tightness. Denied SOB.
Intense abdominal cramps 30 minutes to an hour after eating or drinking (water, tea, juice), lasting throughout the day, subsiding by evening; exhaustion, weakness, occasional cold sweats, feeling flush at times; symptoms seemed to grow day to day, starting out moderate on Thursday, July 29th, really intense on Monday, August 2nd.
This spontaneous report as received from a pharmacist refers to a 54 year old female patient. Patient's medical history, drug reactions/allergies were reported as none. On 16-APR-2014, the patient was vaccinated with ZOSTAVAX vial strength 19,400 plaque forming units (PFU) (lot number J011828, expiry date 26-DEC-2014), dose and frequency unspecified subcutaneous, at back of arm. Concomitant therapies included estradiol. On 17-APR-2014, the patient developed one giant blister at the injection site as well as other small vesicles that were filled with fluid surrounding the giant blister. The reporter mentioned that this patient received ZOSTAVAX subcutaneously in the back of the arm and stated this was where subcutaneous injections were supposed to be given. The patient sought medical attention contacted pharmacist. The patient was treated with VALTREX and prednisone. No lab diagnostics studies were performed. No product quality complaint was involved. VZVIP packet has been faxed. The outcome of one giant blister at the injection site and other small vesicles that were filled with fluid surrounding the giant blister was reported as not recovered. The reporters causality assessment for the events one giant blister at the injection site and other small vesicles that were filled with fluid surrounding the giant blister with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information has been requested.
first vaccination= hives;  second vaccination= generalized rash with discoloration and itching;  booster= bilateral joint pain in shoulders and knees
Following receipt of vaccine, the patient felt very warm, lightheaded, and felt as if we was going to pass out. The patient was also tachycardia at the time.
Broke out with shingles within 10 days of receiving second dose.  Shingles are on my right eye lid, nose, forehead and scalp.
Swollen, painful, itchy rash at injection site.  Also felt very warm to the touch. Still red and slightly sore with some itchiness ongoing a week later.
Within 15 minutes of vaccines (MMR and VZV) patient developed clear rhinorhea, wheezing, angioedema. Given oral Benadryl Nebulizer with Xopenex and ?. Had ? episode with urticaria. Later in evening also resolving ? Benadryl. No further problems.
2-3 day history of 4 small pustules on an erythematous base.  Consistent with chicken pox. Had shot on 6-15-2006
A report was received from a health care professional on 12/8/03 concerning an unknown number of children aged between 4 and 8 years of age and of unspecified sex who inadvertently received 0.25ml Fluvirin on an unknown date. On an unknown date, an unspecified number of children aged between 4 and 8 years of age inadvertently received 0.25ml Fluvirin instead of 0.5ml. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Extreme lethargy and weakness. Entire body involved.  Unable to keep working  for the day.  Feel terrible.  Temp: 99.6.  Elbow pain bilateral (started with first vaccine). I am a nurse.
he had been violently throwing up.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VOMITING (he had been violently throwing up.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Aneurysm of descending aorta (Aneurysm in the descending aorta of the heart.), Type II diabetes mellitus and Drug allergy (No other allergies aside from Clonidine.).    On 10-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (he had been violently throwing up.). At the time of the report, VOMITING (he had been violently throwing up.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter's husband got the Moderna Booster shot earlier, February 10, 2022 and he had been violently throwing up. That was the only dose that the husband had a reaction with. Moderna dose was asked but unknown.  Patient did not took any medications to alleviate the symptoms.
The patient developed shingles on left side back and lateral chest wall. Antiviral medication not given as it was 1 week after onset of symptoms. The patient was prescribed a pain medication.
Patient felt pressure on chest & weakness on inside of left are in the bicep area shortly after getting up at 6 am 3/29/2021.  Slight light-headedness was felt shortly afterwards. Symptoms did not change after moving around & on the advice of patient's insurance company's Nurse Line, she went to the Emergency Room shortly after 7 am. Patient underwent a heart catheterization  that day (3/29/2021) and a cardiac MRI the following day (3/30/2021). Cardiologist informed patient he suspected either Stress Cardiomyopathy or Myocarditis. Patient was discharged 3/31/2021 with 4 medications and follow-up appointments scheduled
Information has been received from a physician concerning a patient who on 26-MAR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) in place of the booster dose of varicella virus vaccine live (Oka/Merck) (MSD). No adverse symptoms reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Presented to ED on 8/30/21; diagnosed with bilateral PEs and right DVT
Developed temp of 103 mom states Tylenol brings temp down, but then it goes back up; Child is pulling at ears today 14MAR91; Advised to have child seen by MD;
Fever; Flu like symptoms; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body Ache) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     .  The patient's past medical history included COVID-19 in October 2020.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body Ache). On 13-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 15-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body Ache) and PYREXIA (Fever) had resolved.            Concomitant medication information not provided.
Initial report received on 03 December 2007 from a health care professional. An adult patient, with no concurrent illness, who was traveling on a cruise ship as an entertainer, had received a subcutaneous dose of YF VAX vaccine (lot number UF197AA) on 26 November 2007. The site of administration was not reported. At an unspecified amount of time later, the patient developed big red spots and burning at the injection site, along with sweating, fever, and nausea. The patient did not seek medical attention. Treatment received was not reported. At the time of this report, the adverse events were resolving. The reported for this case is the same as for cases 2007-04169, 2007-04170, 2007-04171, 2007-04172.