chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Renewed itching after 2nd dose; This is a spontaneous report received from a contactable consumer (patient) reported in response to non-HCP letter sent in cross reference case. A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL92102) (also reported as EL9262 May2021), dose 2 intramuscular, administered in Arm Left (upper) on an unspecified date in Jan2021 (Mid-afternoon, at the age of 77-years-old) as dose 2, single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was unknown and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK4176, expiration date: Mar2021), dose 1 intramuscular, administered in Arm Left (upper) on 31Dec2020 (at the age of 77-years-old) as dose 1, single for COVID-19 immunisation and experienced It's really itchy on his back and several other places left upper arm and bum (Urticaria and Itchy) from 14Jan2021. Vaccination Facility type was Pharmacy or drug store. The patient experienced Renewed itching after 2nd dose on an unspecified date in Jan2021 (3rd week) and the patient stated First dose after 2 weeks was getting better but got worse after the 2nd dose. To the question on event required the initiation of new medication/ other treatment procedure, the patient answered that to many people in waiting room first, was very nervous. No social distance has not gone back for more treatment itching not severe to go back in there. The event outcome was unknown.    No follow-up attempts are possible. No further information is expected.
Numbness on right arm.; tingling on the right arm.; This case was reported by a nurse via sales rep and described the occurrence of numbness of upper extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The field representative called to relay an adverse event reported to him by a nurse practitioner.  The nurse practitioner stated that a patient received the first dose of Shingrix and began experiencing numbness and tingling on the backside of the right arm.  This was reported to the nurse practitioner on 3rd Feb 2023 during a follow up visit and the events had resolved. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Local edema, redness, warmth, 5 inches x 5 inches, right deltoid
80 y/o female w/ hx of celiac dx had been well before and after an office visit where she had Pneumovax and HD flu vaccine started to have N/V and profuse watery diarrhea shortly after eating a Chinese dinner that evening.  Diarrhea cont'd into the ED visit progressing to bloody and mucousy stool.  Pt dropped her BP, became anuric and was admitted to the ICU.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. Vials were placed in refrigerator on 28-Oct-2021. No temperature excursion was reported.
Information has been received from a health professional concerning a 10 year old male who on 06-APR-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot# 632369/1461J). On 10-DEC-2007, the patient developed a rash of less than 50 lesions on the trunk. It was noted that the patient was exposed to chickenpox by his brother. The patient's current status was unspecified. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. Additional information has been requested.
Headache FEVER,CHILLS,FATIGUE,BODY ACHE,MILD COUGH. Narrative:  Other Relevant History:
23SEP91 sl fever, crankiness evening & nite; 24SEP91 evening in bathtub body stiffened turned blue, non responsive, not breathing 20-30 sec; paleness afterwards; ER visit t100.3, WBC 18,000; Hmg 12, HCT 39; put on meds for poss ear infect;
fever of 102 degrees; This case was reported by a consumer and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   The reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st Dose of Shingrix vaccine and experinced fever of 102 degrees F. The reporter did not consent to follow up. This case has been linked with US2020AMR018142, reported by same reporter.      Lab Comments: on an unknown date lab test was performed
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates these unspecified patients were vaccinated with improperly stored VAQTA (strength, dosing details, anatomical location, lot# and expiration date were unknown). No patients reported adverse effects. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
I was diagnosed with covid on 24Mar; I was diagnosed with covid on 24Mar; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA VACCCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and the patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The patient received her first vaccine dose on 08Mar2021. After that she got symptoms on 16Mar2021 and was diagnosed with COVID-19 on 24Mar2021. She was over her symptoms and was feeling better. The outcome of COVID19 was recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
8/28/21 pt was seen in the ED with a positive COVID test; monoclonal antibodies administered during the ED visit; pt was dc'd to home; 9/6/21 pt returned to ED via EMS with increasing SOB; sx have worsened over the last few days; O2 supplementation; pt having fever, nausea and vomiting; poor oral intake; COVID pneumonia; given remdesivir, dexamethasone, ABX; pt had a pulmonary embolism; sepsis; pt made herself DNR/DNI; comfort care measures; she passed away in the hospital
On 2/25, right arm was sore and had fatigue. On 2/26, woke up feeling stiff and achy. On 2/27 in the evening, inner thighs and arms developed a red rash with itchiness. On 2/28, went to ED  where Dr. prescribed 3 tab (60 mg total) of prednisone for 5 days.  On 3/1, rash continued to spread over entire body.  On 3/2, saw primary physician who ordered blood work.  He adjusted prednisone schedule, prescribed hydroxidine, and epipens, and requested followup status. On 3/4, rash and itchiness dramatically subsided.  Today the rash is gone.
I don't have any energy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I don't have any energy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced ASTHENIA (I don't have any energy). At the time of the report, ASTHENIA (I don't have any energy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Information has been received from a doctor of pharmacy concerning an approximately 1 year old female pt who in 12/99 was vaccinated with 1 dose of MMR and within 2 days, post vax, she developed symptoms of pyonephritis. She sought unspecified medical attention. According to serology, the pt's infection resolved but a high fever persisted for 8 days. No further information is available.
Fever Chills Muscle aches Dizzy  Lightheaded  Headache  Fatigue  Loss of appetite  Nausea
Considerable swelling of left hand which prevented closure of the hand with a loss of range of motion of 60 to 70 percent  of normal. There was throbbing pain in various areas and significant ratiating pain during efforts to close the hand .
In June, 2021, my menstral cycle started at day 37.  The bleeding was slow to come, but once it came, it did not stop.    Today is July 27, 2021.  I am only able to control bleeding through using ibuprofen.
Apparently cellulitis at the injection site after VARIVAX administration. No reaction with the other vaccines. Emergency room visit currently with antibiotics.
About 3 months after received vaccine I tested positive for a breakthrough case of COVID-19. Symptoms were mild and last 3-4 days.
I have noticed that my period has been super irregular since I got the vaccine. I'll get it two times in a month or else I won't get it for over a month. If I get it two times in a month then my period will only last a day or two. That hadn't happened to me before. I am still having irregularity with me period at this time. Recently I got sick and was tested for COVID-19. It came back negative. I had a runny nose and was super congested, was coughing, and had headaches. I just took Ibuprofen and Airborne. The symptoms lasted about a week.
migraine, jaw pain, body aches, shoulder & neck tight.  Site of injection is swollen, red, hot to the touch, hurts to move arm.  Discomfort goes shoulder down to injection site. Complains of being tired.
Information has been received from a physician concerning a female who in January 2009, was vaccinated IM with the second 0.5ml dose of GARDASIL (lot# not reported). The patient exhibited "multiple sclerosis (MS)-like symptoms". The date of onset of the symptoms was unknown. The patient was hospitalized overnight at hospital for testing to rule-out multiple sclerosis. The physician relayed that unspecified test results were "non-specific". The dates of hospitalization were unknown. The physician did not provide details of the specific symptoms experienced by the patient but added that "the symptoms are improving." Follow up information was received via telephone call from the patient's mother who worked in the doctor's office and was not a Health Professional provided the patient's full name and birth date. It was reported that the patient was 23 year old and had received 2 doses of GARDASIL. The patient received the first dose of GARDASIL from her gynecologist (GYN) physician (date, dose and lot number unknown to reporter). The patient received the second dose of GARDASIL on 12-NOV-2008 (lot# 659184/0843X) (previously reported as January 2009). The patient began having the following symptoms in the middle of December 2008; "Swelling in her arm, twitches, constant back pain, could not walk at times". The patient was hospitalized of over night, early in 2009 to rule out (R/O) multiple sclerosis (MS) (hospital name and hospitalization dates not reported). The patient's mother stated that the patient could walk and was improving. Follow up information was received via telephone call from a person from the patient's gynecologist's office who provided the doctor's address and reported that the patient received the first dose of GARDASIL on 05-MAY-2008 (expiration date 14-JUN-2009). Additional information has been requested.   8/7/09 Medical records received DOS 11/12/08 to 7/28/09. C/O heartburn, rosacea, joint stiffness. Second dose of Gardasil administered. Post vaccination patient presents with back pain, insomnia.  8/10/09 Hospital records received, multiple ER and inpatient records DOS 12/26/09 to 1/24/09. Inpatient dates 1/23/09 to 1/24/09. Assessment: Bilateral upper and lower extremity weakness. Patient previously c/o sudden onset of right hand pain, swelling, tingling, bluish discoloration and decreased temperature. Questionable median nerve compression. Patient developed intermittent mild bilateral upper and lower extremity weakness. Knees giving way, back pain in cervical thoracic area. Pronounced left leg weakness. Generalized weakness all extremities. Post epidural and post Dilauded. Right deviation of tongue, dysmetria, hyperreflexia. Cervical epidural injection - local anesthetic nerve block.  8/10/09 Hospital diagnostic procedures DOS 12/26/08 and 1/28/09. Patient presents with right upper extremity pain.   Out patient ICD-9 Codes 453.8 Embolism and Thrombosis of other specified veins, 729.5 Pain in limb.  9/16/09 ICD-9 Codes: 722.0 \ksk
Second vaccine received on 4/6/21. Pulmonary Embolism on 4/11/21. Death on 4/13/21.
I had terrible red bump hives on my arm; I contacted my doctor on 04/18/2021 who administered and prescribed me triamcinolone acetonide cream to help reduce the itchiness and spread of the hives from progressing. After using the cream twice a day for about 2 weeks, the hives and itchiness went away on its own and hasn't returned since.
The current adverse effect is an itchy rash that appeared at the site of the injection about 8 or 9 days after the injection. Previously, beginning within 8 hours of the injection, the upper left arm was quite sore for 4 days.
Fever of 104; seen in ER and given MOTRIN and TYLENOL.
Acute basilar artery occlusion resulting in CVA: Patient presented as a stroke alert with rapid onset of altered mental status with nonsensical speech, followed by aphasia. Initial NIH of 20. No history of stroke. No history of COVID.
pt recv vax 6PM 4JUN96 & exp excessive crying & swelling of leg for 4-6hr relieved by APAP
Pt recvd 3 injects of Engerix-B; 1 dose consisted of a "double dose" & pt reportedly became "really sick p/inject"; event abated; Pt did not exp any events w/the next 2 Engerix-B injects;
What has now been label as Covid Arm. Itching at the injection site began approximately four days after injection. I have had a red rash in a circular shape. As of today, twelve days later, it is mildly red and still itches. I am due for my second Moderna on March 31. At this time, it is doubtful I will get the second shot. I had no treatment.
Chronic hives all over the body with angioedema  of the lips, chin, eyelids, and hands. Extremely itchy all over body before hives presented. Took 6-8 Benadryl, 4 doses of Xyzal, Allegra, or Zyrtec, Pepcid, Singulair, and Vitamin D per day in addition to three rounds of prednisone. Hives were severe and not controlled until 9/18/21 and are now mild while taking all of the above mentioned medications.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 22-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Right arm has been swollen/swollen for over 4 months; It is hard; Eyelid twitching about 2 months after the shot; Balance has been off; Swollen from above my wrist all the way up to my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm has been swollen/swollen for over 4 months), INDURATION (It is hard), BLEPHAROSPASM (Eyelid twitching about 2 months after the shot), BALANCE DISORDER (Balance has been off) and JOINT SWELLING (Swollen from above my wrist all the way up to my shoulder) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Right arm has been swollen/swollen for over 4 months), INDURATION (It is hard), BLEPHAROSPASM (Eyelid twitching about 2 months after the shot), BALANCE DISORDER (Balance has been off) and JOINT SWELLING (Swollen from above my wrist all the way up to my shoulder). At the time of the report, PERIPHERAL SWELLING (Right arm has been swollen/swollen for over 4 months), INDURATION (It is hard), BLEPHAROSPASM (Eyelid twitching about 2 months after the shot), BALANCE DISORDER (Balance has been off) and JOINT SWELLING (Swollen from above my wrist all the way up to my shoulder) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.
No additional adverse effect reported; patient was administered a dose of properly stored but expired PNEUMOV AX 23 which expired on 3/1/2020; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 16-MAR-2020 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # R007721, intramuscular for prophylaxis.  lot number R007721 which had already expired on 01-MAR-2020. No additional adverse effect reported.
Patient received dose 1 vaccine. While sitting in waiting area for observation patient fainted and fell to floor. Patient briefly had seizure activity in limbs for 5-10 seconds then became alert. Paramedics were contacted and assessed patient. Patient was recommended to follow up with primary care.
High fever(over 103), nausea, vomiting, profound weakness, severe headache for 5 days- please note, I had covid and recovered on January 1, 2021. My physician believes my intense reaction was caused from having the vaccine administered so soon after having COVID. My physician has requested that I not receive the second dose.
Body ache and joint pain, feeling hot, chills so bad my teeth chattered, fever 100.7, vomiting, dizzy, raging headache, fatigue
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 09/16/2021. PATIENT FULLY VACCINATED ON 02/10/2021. PATIENT RECEIVED MONOCLONAL ANITBODY INFUSION ON 09/17/2021
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with VARIVAX (Merck) which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding an 18 year old male patient. On 01-JUL-2014 at 1:30 PM, the patient might have been immunized with a dose of VARIVAX (Merck) lot number J009165, expiration date 24-JUL-2015, in the right upper arm (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Entire body itchy and burning. When parts of body were scratched, the area would get red and inflamed. Area would stay inflamed for an hour. On day 2, entire body red after a hot shower and inflamed. I saw my doctor. She prescribed Zyrtec BID, Benadryl 25-50mg BID PRN and Pepcid 20mg BID. I started the meds that day (Dec 22). As for today the itchiness comes and goes. When I scratch, it doesn't get inflamed anymore.