chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Meningococcal given 3/16/2015, symptoms started 3/17/2015. Pt here today 3/18/15 c/o redness, warmth, indurated and nonfluctuant to (L) deltoid. Approx 12cm x 14cm.
her neighbor got tired after 2nd dose; 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 FATIGUE (her neighbor got tired after 2nd dose) 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 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 FATIGUE (her neighbor got tired after 2nd dose). At the time of the report, FATIGUE (her neighbor got tired after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089114, MOD21-080986, US-MODERNATX, INC.-MOD-2021-089137 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089114:Patient case MOD21-080986: US-MODERNATX, INC.-MOD-2021-089137:
After vaccination, patient had seizure-like activity lasting approximately 5 seconds. After seizing activity ended, patient complained of dizziness and pain in the vaccinated arm. Patient remained at the fairgrounds with her husband (who was also vaccinated)  for approximately 2 hours after episode. Patient was driven home by her husband.
Patient received her flu shot on 9/15/2020 and called me today to say that her arm/shoulder has been hurting her since her vaccine.
Hair Loss severe, insurance refused to pay for  the medication the doctor ordered.  Doctor recommended Rogaine for Women for 4 months.
Patient came into the pharmacy in the early evening (about 5:00 PM) on 05/01/2015 to inquire about what appeared to be a site reaction likely due to the Zostavax she received on 4/29/15 from pharmacist.  She was pleasant and seemed only mildly concerned. I examined the area and informed her that it did look like she had a localized site reaction due to the vaccine and that it did sometimes occur in some patients.  It was about 2 to 3 inches in diameter and was red.  Patient also said she could feel a hard lump underneath the area when touching it with her fingers.  She said it was not painful. She did not complain of any other symptoms.  I told her that it would probably go away on it's own within a few days but that if it got worse, did not improve or if other symptoms developed to call her primary doctor.  She agreed and left the store.  I followed up with her this morning by calling her at home and she said that the area had not yet improved.  I advised her that she could apply some ice to the area to try to reduce some of the redness.  I faxed notification of the adverse event to both the protocol physician as well as to the patient's primary physician at about 4:15 PM on 05/02/15 as I could not reach them on the phone over the weekend. I also documented the adverse event through the corporate reporting system as well as notifying both our pharmacy supervisor and the immunization coordinator.
Patient is 41 year old who presented  with right sided upper and lower extremities weakness with facial drip , call as code stroke level 1  -CTbrain, CTA showed right basilar ganglia hemorrhage with small volume subarachnoid hemorrhage,  left middle cerebral artery thrombosis with left basilar ganglia infarct and right basilar ganglia infarcts. TEE was negative for LV thrombus /vegetation .
Information has been received from a certified medical assistant concerning a 14 year old female with no pertinent medical history who on 14-May-2009 was vaccinated with the first dose of GARDASIL (lot# 661764/0650X), o.5ml, intramuscular administration. There was no concomitant medication. On 14-May-2009 the patient "passed out" immediately after the vaccination. Subsequently, the patient recovered without requiring treatment and was released to home fully recovered. Additional information has been requested.
Apparent allergic reaction to Proquad. Area of erythema approx. 4cm with induration (hive) approx. 1cm at site of injection. Appeared within 5 min. of immunization being given L arm. Given 12.5mg Benadryl po and gradual dissipation in size of induration. (Local allergic reaction).
Patient reported to pharmacy on 06/30/2021 at approximately 11am EST with redness and swelling at site of injection. Patient reported swelling and redness occurring approximately one week after receiving second dose of COVID-19 vaccination. Patient reported that he has had incidence of bleeding on and off at the site of injection. Advised patient to contact primary care provider and to report adverse reaction.
She had low pneumococcal titers with good response to booster; 21 month old twin girls received pneumococcal vaccine; Literature report:  This literature marketed report has been received from authors of the literature article entitled as stated above.   This report referred to a 21 months old female patient born at 35 weeks with 22q11.21 microduplication syndrome. The patient had narrow aorta without surgical intervention required and with normal immune system. The patient had slight speech delays. The patient was healthy without history of recurrent infections and was up to date on vaccines including live virals. No other physical abnormalities such as cleft lip or palate or known electrolyte abnormalities.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, strength, route, lot# and expiration date were unknown) for prophylaxis (product administered to patient of inappropriate age.).  On an unknown date, the patient experienced low pneumococcal titers with good response to booster. The outcome of low pneumococcal titers was unknown. The reporter considered low pneumococcal titers to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports obtained from the same literature (2202USA003399).; Sender's Comments:  US-009507513-2202USA003399:
Patient received 2nd pfizer COVID vaccine at 1300 and went to observation area with her sister as a companion for extended monitoring due to multiple allergies and patient reported lip swelling and darkening with 1st dose. Patient states that after her first pfizer COVID vaccine that she experienced lip swelling and darkening about 1.5 hours post vaccination. She states that she went to her PCP to be checked out and that by the time she got there 4 hours later it had resolved. She states that her PCP did not give her any guidance on receiving her 2nd COVID vaccine. Patient reports that then after her first dose she went home and napped for about 4 hours. No further symptoms reported after 1st vaccination.   1330: 30 minutes after vaccination, Observation RN checked on patient and she reported feeling concerned that her lip was swelling and the color change was occurring again. Patient assessed by observation RN and EMT. No tongue or oral swelling noted. Patient denies any difficulty in breathing or swallowing. Patient wanted to continue to wait in the observation area to see if it was getting worse.   1345: patient reports that she still feels like her lips have some swelling and there is a color change on the outer portion of her lips. Writer does note any obvious swelling, but does inform patient that she did not see her lips prior to receiving her vaccine today. Patient states that she would feel more comfortable receiving benedryl here rather than be driven home by her sister and son as she lives 30 minutes away from here. Patient given 25mg benadryl IM in right deltoid at 1350. Patient agrees to be monitored for 30 more minutes.   1405: Patient reports that her lips feel better and decrease in swelling. Lips and tongue again observed by writer and EMT and no obvious swelling or darkening to lips noted. Patient reports feeling drowsy, but is easily arousable and reports ears aching.   1420: Patient checked on again and reports that she feels able to go home. She denies any ear ache at this time. She is offered to be checked out at the hospital but denies. Risks and benefits explained of going home vs. Going to hospital to be checked out. Patient and her sister verbalize understanding and patient continues to state that she feels well enough to go home. Patient and sister verbalize understanding that if anything changes she is to call 911 or head to the nearest hospital. Patient is then walked down with writer to car.
Fatigue, headache, achy muscles, tingling muscles, sore arm at site of injection.  Lasted from midnight until next evening  - 15-18 hours duration
I have terrible psoriasis now all over my body including my face and scalp. I have not been able to preform my job at all to this condition.
02/14/23 presents to  ED for "shortness of breath". PMHx of "COPD, NSTEMI, and a-fib"
pt devel pea sized lump @ the inj site;the lump turned into a dimpled indentation which persists;
She experienced 3 strokes; This is a spontaneous report from a contactable consumer.  A female patient of unspecified age received BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration  on 12Mar2021 (lot number and expiry date not reported) as a single dose for COVID-19 immunization. The patient's medical history included severe Factor 7 deficiency. Concomitant medications were not reported. On 12Mar2021, 50 minutes following the injection, the patient experienced 3 strokes. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt has swelling from injection site, in right upper arm down to elbow, injection site pain, and entire arm pain.
After receiving injection patient walked out of pharmacy and sat in chair in front of pharmacy. About 8 minutes or so later, patient fell back in the chair and passed out. I ran over and called the patient's name who came to, and he felt warm and sweaty. Patient was able to recall his name, the day of the week, and where he was. About 2 or 3 minutes later after coming out to the patient, he vomit into a trash can and then stated he felt much better.
HYPOXIA 1/19/2023 CKD STAGE 3A (GFR 45-59) HYPOXIA 1/19/2023 BILAT HEARING LOSS HYPOXIA 1/19/2023 BRADYCARDIA HYPOXIA 1/19/2023 BILAT HEARING LOSS HYPOXIA 1/19/2023 BILAT HEARING LOSS
On 10/08/2020 at 9:30 AM he had an Acute cerebrovascular accident  (CVA)  Treated for stroke, Strength came back but cannot make sense of the written word,   It is called Expressive Aphasia AKA Broca's Aphasia.
Heat development; Cellulitis; Swelling the size of an orange; Itchy skin; Red skin covering upper arm; Arm pain; This spontaneous report was reported by a consumer concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was sore with restricted movement, swelling, site turned red and spread through entire upper arm, itchiness, heat and cellulitis.  The patient's medical history was not reported. The concomitant medication included Metformin, Clonidine, Lisinopril, Metoprolol, Synthroid, Citalopram, Xanax and Vitamin D.   On 2 Mar 2021, 1 day prior to the onset of the event, the patient received the first dose mRNA-1273 (Lot number -013A214) via intramuscular in left arm for prophylaxis of COVID-19 infection.   On same day the patient reported the arm was sore with restricted movement.  On 10 Mar 2021, patient reported swelling near orange size,  the site turned red and spread through entire upper arm and itchy skin.   On an unknown date heat developed and doctor believed patient developed cellulitis secondary to the vaccination.  Action taken with the mRNA-1273 in response to the events was not provided.   The outcome was recovered for swelling, arm pain and red skin and unknown for rest events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Systemic: Redness, swelling and heat below injection site above elbow-Mild.
Patient who received the 2nd Pfizer dose a week earlier for the COVID; Patient who received the 2nd Pfizer dose a week earlier for the COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient who received the 2nd Pfizer dose a week earlier for the COVID".  Clinical course: Reporter stated, they had a patient who received the 2nd Pfizer dose a week earlier for the COVID, they were (Age withheld) (Further clarification was unknown), didn't know what the risk of that or repeating the dose or what and don't know we had reported it but just wanted the recommendations. When again probed for the concern, reporter stated, "they had already reported this, (Age withheld) year old who got the 2nd dose of the COVID vaccine a week 'earlier'. So curious about the clinical ramifications, repeating the dose thing and immunity stuff like that. Reporter stated, don't have LOT information unfortunately. QR comment: Patient count was unspecified over the call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Client was vaccinated next to EMT ambulance due to prior allergic reactions and medical history. Approximately 3 minutes after vaccination, client reported onset of throat tightening and proceeded to progress to a full anaphylactic reaction, with stridor and respiratory distress.   At one minute after onset of symptoms, patient was administered 0.3 mL epinephrine IM in the left deltoid, and was transferred to a gurney and then into the rig, where oxygen was applied via non-rebreather mask at 12L/min, and vital signs were taken with  a HR of 96 and BP of 146/113.  Respirations were stridorous and approximately 40-60.  SaO2 after oxygen was high 90's.   Within the next 3-5 minutes, stridor lessened and client appeared more comfortable and gave a "thumbs up sign". IM Benadryl was given at approximately 8 minutes post onset.  A second transport ambulance from Medical Center was requested at onset of symptoms and arrived shortly after the dose of Benadryl.  Stridor was minimal and vital signs were HR 95, BP 123/78, with improved respirations, minimal stridor, no accessory muscle use and good air entry.  SaO2 was 100% on oxygen. IV attempt was unsuccessful by local EMT and patient was transferred to the second team for further care and transport to the Medical Center.
pt exp chest pain tx w/pred;26NOV96 c/o chest discomfort, feeling tired, sore throat, aches in the elbows & lt wrists;pt may be exp esophageal reflux tx w/zantac;c/o pain in elbows, aches in knees;suspected rheumatoid arthritis;
Leg cramps; Discomfort near the heel and calf; This is a spontaneous report from a contactable consumer, the patient. A 27-year-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 arm left on 03Apr2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). The patient had no known allergies. Concomitant medications included MILK THISTLE 500 mg and QUNOL COQ-10 20 for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 09:00, the patient experienced leg cramp and discomfort near the heel and calf. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events leg cramp and discomfort near the heel and calf was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Redness and blistering at the injection sight 5-29-15. Site applied heat with resolution: 6-1-15 residual 5 mm x 8 mm erythematous papule.
Within 20 minutes of receiving vaccine, felt itching and redness with warmth to site of vaccination, left deltoid.
A few minutes after immunizations-child complained of feet itching, eyes blood shot, began vomiting.  Within 5-10 minutes, child began to get very drowsy, body felt warm, cheeks flushed, legs red, continued to complain of nausea.  Blood pressure: 90.50.  Sent to ER via ambulance.
My neuropathy has increases, progression in my CMTA 1A has taken place, more muscle loss more nerve damage felt
neck pain was quite severe for three months after the vaccine; couldn't even get out of bed and function properly; General body aches; Neck pain left side and I got my shot in my left arm; General sick feeling; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain left side and I got my shot in my left arm), MALAISE (General sick feeling), CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine), VACCINATION COMPLICATION (couldn't even get out of bed and function properly) and MYALGIA (General body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced NECK PAIN (Neck pain left side and I got my shot in my left arm), MALAISE (General sick feeling) and MYALGIA (General body aches). On an unknown date, the patient experienced CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine) and VACCINATION COMPLICATION (couldn't even get out of bed and function properly). On 25-Feb-2021, MALAISE (General sick feeling) and MYALGIA (General body aches) had resolved. At the time of the report, NECK PAIN (Neck pain left side and I got my shot in my left arm) had not resolved and CONDITION AGGRAVATED (neck pain was quite severe for three months after the vaccine) and VACCINATION COMPLICATION (couldn't even get out of bed and function properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information  provided. The patient's neck pain began the same day but didn't reach its worst severity until the third day after the first shot.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received as new events aggravation of existing disorder, vaccination related malaise was added.
This spontaneous report was received from a certified medical assistant concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers: K005110, K014833, K021152, K024038, L005290, L011528, L012480, L020189, L030162, L032182, L037356, M007277 and M015930 (strength, dose, route of administration and expiration dates were not reported) for prophylaxis. It was reported that all vaccines involved in temperature excursion were vaccines for children (VFC). The administered doses of M-M-R II were exposed to temperature excursions between 26° (unspecified units) (lowest) and 75° (unspecified units) (highest) for 12 hours each day, from 15-DEC-2015 to 31-MAR-2017. No adverse effects were reported. A digital data logger was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007467: US-009507513-1705USA001208: US-009507513-1705USA001209: US-009507513-1705USA001210: US-009507513-1705USA001212:
Patient stated she "felt weird" when she woke up at 0500. At 2:00 PM she became weak, it was hard for her to walk. Stated bilateral arms and legs were weak. Reported to her PCP. Flu test (-), sent home. 1/14/14 Back to her PCP. Now only feels weak on (L) side, sent to hosp. for stroke work up.
1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED.  Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]
patient got 2nd dose greater than 42 days interval; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose greater than 42 days interval) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided.
High fever, extreme fatigue, aches and and chills began about 4 hours following the vaccine booster on Thursday afternoon and these symptoms continued throughout the weekend until Sunday evening. Fever was between 102 and 103 degrees and would return each time the effects of Tylenol would wear off after 4 or 5 hours.
I21.4 ACUTE NON ST ELEVATION MI 6/1/2021 HYPOKALEMIA I21.4 ACUTE NON ST ELEVATION MI 6/1/2021 ACUTE NON ST ELEVATION MI
Nausea and vomiting 12 hours after receiving the 2nd dose of the HPV vaccine. Stomach ache ensues.
PATIENT SAID SHE GOT THE SHINGLE AND SHE GOT RASH AND ITCHING UNDER HER BREAST