chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body pain; headache; sore arm; This case was reported by a consumer and described the occurrence of general body pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on 29th December 2018, refer case US2019GSK093712).   On 3rd May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a month after receiving Shingrix, the patient experienced general body pain, headache and pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, headache and pain in arm were unknown.   It was unknown if the reporter considered the general body pain, headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and was better but had a little headache, whole body feel moderately sore and arm was very sore or when moving for a couple of days then just sore to touch for a few days.
pt recvd vax; few hrs later, exp tingling in the fingers; these sxs resolved by the next day;
THE PATIENT HAD 2 DOSES OF MODERNA, WAS GIVEN PFIZER AS A 3RD DOSE INSTEAD OF MODERNA. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS.
This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took amoxicillin on unknown date for an unspecified indication and experienced drug allergy. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 16:00, the patient experienced sore arm and a little tired. Tiredness went away the next day and no other side effects. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm was resolved on an unknown date in Mar2021 and a little tired was resolved on 10Mar2021. No follow-up attempts are possible. No further information is expected.
Shortly after the vaccination the site was red and hot. We applied ice to the area and encouraged movement. Later that evening we noticed he was limping more when he walked. When we compared his legs, the leg that had the vaccination was swollen from hip to knee. We applied more ice, encouraged movement, and gave BENADRYL. The leg was very sore and tender the following day as well. We again used BENADRYL and encouraged movement. He did not want to walk. (We did not phone the doctor as this same reaction happened when patient was 18 months old.) We monitored him at home and watched for improvement.
1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.
Pt recvd vax &  1 day p/vax exp rash big red blotches all over that started on neck & covered torso, arms & legs; treated w/hydorcortisone cream rash resolved in a few days;
Swollen vaccinated arm with blue fingers the morning following vaccination; felt so poorly that she was unable to go to work.
Patient felt "sick," dizzy, and developed numbness in her fingers. this lasted for 30 seconds. She felt as though she was going to "pass out," but she never lost consciousness or vision. She was provided water and orange juice, and she felt better. Her systolic blood pressure dropped from 90s to 70s, but went back up to the 90s over an hour or two. Pallor, but no rashes. no cough, wheezing, nausea, vomiting, diarrhea, chest pain, or headache.
Information has been received from a nurse practitioner for the pregnancy registry for GARDASIL concerning a 17 years old female who on 07-JUL-2008 was vaccinated with the first dose of GARDASIL.  Concomitant therapy included PROZAC, XANAX, trazodone HCl and albuterol.  The nurse practitioner reported that the patient may have been pregnant when the first dose of GARDASIL.  No adverse reactions reported.  The last menstrual period was 18-JUN-2008.  Her due date is 25-MAR-2009.  The patient sought medical attention, she was seen by nurse practitioner.  There was no product quality complaint.  Additional information has been requested.  Follow up information has been received from a nurse practitioner that reported that the patient had an elective termination of her pregnancy last week at approximately 8 weeks estimated gestational age (EGA) (approximately 08-AUG-2008).  The nurse practitioner reported that she saw the patient on 13-AUG-2008 and she seemed to be doing well, following the termination of her pregnancy last week at approximately 8 weeks EGA.  The nurse practitioner stated that the decision to have the termination was not due to the GARDASIL.  The patient was also being treated with PROZAC, XANAX and trazodone HCl, and had concerns related to these medication as well as other concerns.  Upon internal review termination of her pregnancy was determined to be an other important medical event.  Additional information is not expected.
Pneumonia vaccines administered in 2014 and 2018; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (2112USA008003), concerning a 70-year-old male patient. His concurrent conditions included Parkinson's disease, tic douloureux/nerve pain, high cholesterol and high blood pressure. He smoked cigarettes (approx. 4 cigarettes a day) from 1967 to 1972. On 01-JUN-2009 (also reported as on 01-OCT-2014, conflicting information), the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) with an adverse reaction of shingles. Concomitant therapies included atorvastatin, lisinopril (manufacturer unknown), carbidopa (+) levodopa and topiramate.  On an unspecified date in 2014, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of vaccination, vaccination site, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumonia vaccine) (dose, route of administration, vaccination site, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). The patient had no adverse reactions or side effects after the vaccines.  This is one of the two reports received from the same reporter, concerning the same patient.; Sender's Comments:  US-009507513-2112USA008003:
Both arms broke out in hives from shoulders to wrists (on on the underside though).Then it moved to my chest Thursday. Then it moved to my thighs Friday and to my lower legs by Sunday (today).; My shingles also flared back up; Tuesday (3/23) evening my shins started itching really bad. There were no visible signs of a rash or hives. They continued to itch through Saturday.; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 15:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included CREST Syndrome. The patient previously took codeine and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient received unspecified medications within 2 weeks of vaccination. On 23Mar2021 at 18:00, the patient experienced really bad itching and there were no visible signs of a rash or hives which continued to itch through Saturday. On 25Mar2021, the patient had shingles flaired back-up. On 31Mar2021, the patient's both arms broke out in hives from shoulders to wrists (on the underside though) and by thursday it moved to chest and by Friday to thighs and by Sunday to lower legs. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for itching, shingles and hives. The clinical outcome of the events itching, shingles and hives were not resolved at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
One hour after vaccination, experienced increasing pain through out left arm.  After 3 hours I was unable to use my arm at all.  Pain continued for 3 days.  Also shallow breathing.  Called my Dr's office to report the problem on day 2 and was told to take ADVIL for pain or go to hospital ER.
redness spreading below the inj site, itching, warm & painful lt upper arm;h/a, neck pain;
Case number PHEH2017US003256 is initial spontaneous case received from pharmacist on 30 Jan 2017. This report refers to 80 year old male patient. Medical history was not reported current condition included diabetes, high cholesterol and high blood pressure. Concomitant medication included: metformin hydrochloride, simvastatin and lisinopril and hydrochlorothiazide. Past vaccination history included: Influenza vaccine 2013, 2013 and 2015 and well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 169003, expiry date: May 2017) at dose of 0.5 ml intramuscular on 28 Jan 2017 at 3.30. Temperature excursion was reported with FLUVIRIN pre filled syringe (PFS). The maximum temperature reached was 51.44 degree F for 2 hours 30 minutes. This was the first excursion and vaccine was given to one patient. No adverse event was reported following this medication error. Follow up information was received from pharmacist on 28 Feb 2017. The patient current condition added (diabetes, high cholesterol and high blood pressure) concomitant drug added (metformin hydrochloride, simvastatin and lisinopril and hydrochlorothiazide) vaccination time and anatomical site added 3.30, left arm and past vaccination history added. And updated narrative accordingly.
Pt states she had some pain immediately after the suregery, but still has some intermittent bouts of pain following the administration
Fever, runny nose, coughing, congestion, wheezing, gasping for air when coughing, no appetite, lethargic, fussy. We notified the office on 12/19/2014 @ 1:41PM and we were told to keep her hydrated and comfortable by the nurse on call. The nurse also told us not to bring her in and to call the doctor on call on 12/21/2014 to update the office on her status.
Giant red welt, approximately 1.5-2 inches in diameter. Welt was painful, especially when touched. Upon visit to clinic, doctor indicated that they did not believe it was dangerous/deadly, but that reaction was severe enough that it warranted a report.
pt devel 10-12 lesions following exposure to child who had devel chicken pox p/ vax;
15 minutes later severe pain on right side of body from him to chest which lasted about 15 second. Tightness. After 10 minutes felt like having contractions. on right hand and arm felt woozy, felt faint. Lasted a minutes. Patient was concerned so went back to doctor who was closed, to urgent care which was also closed so went to ER. Felt better by the time patient arrived so did not go in. Next day had pain, tightness on back of neck. On 2/22 pain on neck similar to when had shingles before. Today feels fine.
Left upper thigh is red, swollen and hot to touch. Injection site red >2". Able to walk on leg. No noted fever, chills. No pus or drainage. No red streaks.
Patient presented to office with L thigh area red, swollen, and hot. Area size approx. 3 in. x 4 in. and spreading into groin area. Instructed to apply ice packs off and on and ATARAX was prescribed.
Experienced post menopausal bleeding for about 2 weeks after the first dose given on 4/15/21 and after the second dose, had more pronounced bleeding that lasted longer and is still experiencing spotting now.
2 hours, post vax, child had decreased activity, would not eat, ran a fever and appeared limp for 2-3 hours.
rheumatoid arthritis; immune compromised; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient was a recipient of the Pfizer vaccine [covid], the patient had failed to produce antibodies. The patient had three different tests and wanted to ask if there was any way that could participate in any Pfizer study where the patient can have more access to the vaccine and maybe contribute. The patient was immune compromised. The patient had rheumatoid arthritis and took medications for them. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Presented with full body urticaria starting in the palms, wrists, neck, groin, and ankles. Extremely itchy welts persisted so visited a walk in clinic the next day, was told "your body came into contact with something it really didn't like" and was prescribed 5 days of prednisone. Symptoms got much worse that night, so revisited the clinic again and was subsequently prescribed Hydroxyzine and recommended to take Claritin and Famotidine. After starting antihistamines and finishing steroids, the full body hives subsided for the most part, with random flare ups each day that go away over the course of a couple hours. Developed skin writing (Dermatographia) at about day 2 of onset of symptoms and still persists regardless of antihistamine use. The slightest scratch or even rubbing of my clothes or glasses against my skin causes lines. I can draw pictures on my skin and welts in the shape of the drawing appear within a minute and disappear within the course of about 30 minutes or so. Rubbing of my eyes or lips, and cleaning of my vuvla in the shower also seems to cause a swelling reaction. At the beginning and height of my symptoms I also experienced widespread joint pain, swelling of lymphnodes in the neck and armpit, and even suspected swelling of salivary glands that made it painful to move my jaw or chew. Also experienced bad heartburn and chest pain and tightness, although that could have been a side effect of the steroids as it mostly subsided after discontinuing use.
site of injection hard; site of injection swollen; Arm hurt and  site of injection spread all over the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm), VACCINATION SITE SWELLING (site of injection swollen) and VACCINATION SITE INDURATION (site of injection hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm). On 17-Jan-2021, the patient experienced VACCINATION SITE SWELLING (site of injection swollen). On an unknown date, the patient experienced VACCINATION SITE INDURATION (site of injection hard). The patient was treated with AMOXICILLIN (oral) for Pain and Swelling, at a dose of 500 mg. At the time of the report, VACCINATION SITE PAIN (Arm hurt and  site of injection spread all over the arm) had not resolved and VACCINATION SITE SWELLING (site of injection swollen) and VACCINATION SITE INDURATION (site of injection hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided
Got a breakthrough infection with covid; Sore throat; Lethargic; Her loss of taste and smell still has not come back; Her loss of taste and smell still has not come back; it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible; Headache; Extreme tiredness; Patient received the second dose of the vaccine 21 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) in a 55-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.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose). On 07-Jul-2021, the patient experienced COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back), AGEUSIA (Her loss of taste and smell still has not come back), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose) had resolved. At the time of the report, COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness) outcome was unknown and ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative for Covid.         Concomitant products were not provided. Patient was not on any medication and had no health conditions Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains no new information
20JUL92 1130AM recved DTP/OPV/HIB; 22JUL92 12MN t105; seen @ ER dx otitis;
Vaccine given around 4:30 PM 07/22/2021 Started feeling achy, feverish, chills and headache around 8:00 PM 07/22/2021 Went to bed around 11:30 PM tossed and turned waking every hour 07/22/2021 Temperature taken @ 3:45 AM was 101.9 and @ 5:30 AM was 102.1 07/23/2021 Called NP at 6:30 AM asking about taking Tylenol and Ibuprofen due to the pamphlet stating to check with health professional first . Was advised to alternate OTC Tylenol and Ibuprofen. 10:00 AM 07/23/2021 low grade fever, still achy and headache 7:00 PM 07/23/2021 feeling better just achy from laying around
After administration of the third dose,  The patient was administered morphine and Zofran.  CT abdomen/pelvis was obtained.  Upon returning from the CT scanner, the patient became less responsive and hypoxic.  He was placed on a nonrebreather and initially improved.  CT showed possible infiltrates at the bases of the lungs
Patient awoke that morning with slurred speech , right side of face drooping, tongue feels tingly, right arm feels heavy. Face felt heavy and when drinking fluid it ran out of her mouth,. Mother took her to Urgent Care and they diagnosed  her with Bell's Palsy.
Modest fever blister inside lower lip.  Still present after about 48 hours.  Extreme fatique from ordinary house work.  Had to stop working and try to sleep during the day.  Still present after about 24 hours.
Hospital Course This is an 83-year-old male who presents to Medical Center with complaints of altered mental status.  Patient moves an apartment by himself and was found on the floor in the building where he lives.  He was confused and EMS was called by a neighbor.  His initial blood pressure was 70/50s.  Patient was given intravenous fluids in our emergency department with improvement in systolic blood pressure. CT head was unremarkable for any acute change chest x-ray with bilateral pneumonia patient was tested positive for COVID-19 in the emergency department.  His creatinine was elevated at 2.48.  High-sensitivity troponin was 119 then 175. Patient admitted for further management .  Patient was found to have E. coli bacteremia treated by IV antibiotics followed by ID service patient also was followed by pulmonology for respiratory failure acute kidney injury by nephrology service.he was noted to have type II MI. Limited echocardiogram  for normal LV systolic function cardiology consult.  For treatment kidney function improves.  Encephalopathy was thought to be secondary to metabolic and sepsis which improved patient evaluated by neurology service. ID service recommended to switch IV medication to oral and discharge home No acute overnight events.  Patient has no new cardiovascular complaints.  He is on room air. Patient cleared by all other services for discharge patient and family agrees the discharge plan
Red, raised rash near injection site. No pain or itching at the onset. Occasional tingling/stinging. After 4 days itching began.
Rash began on 11-29-09 on face then went to trunk and extremities. Family reacted individual was "extremely ill" including vomiting, headaches and fever. Family reported rash was pussy but uniform. Individual taken to urgent care due to unusual circumstances. Client diagnosed with atypical chickenpox secondary to vaccination.
I got really sick the next day with a fever of 100.1. I was unable to move, walk and to do selfcare. I was turning really red, very swollen and my heartbeat was super-fast. I couldn't eat.