chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In December 1999, the vaccinee developed intermittent twinges in legs and his ankles were sensitive to touch. In April 2000, he developed numbness in his feet and pain in his legs. The vaccinee reported that he was told he had peripheral neuropathy. A doctor visit was required. No treatment was given.
Immediately post vaccine administration, patient experienced syncope (fainting). Eyes rolled back, sweating, lost consciousness. 15-20 seconds later regained consciousness as if nothing happened. Provided patient 4 glucose tablets and sat/spoke with him for an additional 15 minutes
Bumpy rash on face, neck and chest area.  Not red, but clearly raised.  Not visible until up close and can feel it.  Some itching associated with it.
vaccine was stored in fridge beyond 30 days when administered to pt; follow up with pt; pt no adverse reaction; advised repeating dosage
I started with a rash on my chest which spread to my abdominal area and very top part of my thighs
Information was received from a nurse concerning a 4th grade student who on 25 JAN 1996 was vaccinated with a dose of Varicella.  On 17 DEC 2004 the student developed chickenpox.  According to the school nurse there were 58 other elementary school students and 34 of them had previously been vaccinated with a dose of Varicella.  Unspecified medical attention was sought.  There was no information regarding the present status of the student.  No product quality complaint was involved.  Additional information was requested.
Approx 10min after injection while sitting in waiting area, c/o  dizziness, lightheadedness. Attempted to move patient to exam room but began to faint. Gently lowered to floor by the doctor and myself. No injury resulted in being lowered to floor. Patient remained there for Approx 15min assisted to exam pulse normal room until alert. B/P 14/74
Initially after getting the vaccine I had mild to moderate soreness in my arm for about 1-2 days which then subsided.  Then on Jan.7 I began to have itching at the injection site and a 3x4 inch area of redness.  I applied some OTC 1% hydrocortisone cream which did lessen the itching but redness persisted.  Today, Jan.10 the redness measures approximately 3 1/2 x 4 1/2 inches, itching is present at times and area is warm to the touch.  I have no fever and arm feels only slightly tender right where needle was inserted.
Initial misuse report received from a healthcare professional on 23 July 2013. A 04-month-old patient had received a dose of ACTHIB vaccine and also the ACTHIB in the dose of PENTACEL vaccine on 22 July 2013. No adverse event was reported. Documents held by sender: None.
chronic diarrhea, stomach cramping  Since two days after receiving the second dose of Moderna vaccine, I have had chronic diarrhea throughout the mornings. Bowel movements are not formed. Before the vaccines, my bm's were consistent (1x/day, well formed) requiring magnesium to help soften my stool. I have since stopped taking magnesium.  I have experienced painful menses in the past however week two after receiving my second dose I had severe stomach cramping that woke me up at nights and consistent for seven days.  Menses was regular.
No additional AE reported; expired product administered to a patient; ONE of TEN vials has a different lot/expiration date/The affected VARIVAX with LOT S020464, EXP Jul 2, 2021, was administered to a patient; expired product administered to a patient/ONE of TEN vials has a different lot/expiration date/The affected VARIVAX with LOT S020464, EXP Jul 2, 2021, was administered to a patient; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one vial, lot #S020464, expiration date: 02-JUL-2021, administered for prophylaxis (strength, dose, dose number and route of administration were not provided) (expired product administered).  The nurse reported that the other 9 doses matched the carton, which was sealed/intact/free from damage or physical defects, however this issue was not discovered until the product was used. She investigated the issue at the day of this report with another nurse and identified that the one vial had a different lot/expiration date compared to the remaining vials in package. The nurse practitioner confirmed that she had never carried varicella virus vaccine live (oka/merck) (VARIVAX) with lot #S020464. The lot # had no prior temperature excursions. No additional adverse event (AE) reported.
Patient became nauseated about 10 minutes after vaccine administered, this subsided but returned several hours after the vaccine was given. She continued with intractable nausea and vomiting for about 24 hours.  This patient was enrolled in hospice and she continued to decline and refused to eat or drink. She was taking Ibuprofen due to intractable back pain. Her emesis was coffee ground color. After this her condition continued to decline until her death
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No information on concomitant medication were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Received SARS Coronavirus 2 RNA-SARS-CoV-2, NAA test at Pharmacy on 07/05/2021 at 12:15. Case investigation interview has not been completed for this individual at time of writing this note.
LARGE RED AREA AT SITE OF INJECTION, RED AREA IS RAISED AND WARM TO THE TOUCH, AREA IS PAINFUL TO LAY ON
Patient complained of swelling and tenderness (to the touch) of the neck and shoulder on the same side as the vaccine was given.  No reaction seen on other side of neck or shoulder.  Also complained about back muscles seizing up while shopping.  The pain and swell went away within 2 days, but was still tender (not as drastically as before) on the 17th of February
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 81-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. Concomitant products included Shingrix. On 13th August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th August 2018, immediately after receiving Shingrix, the patient experienced injection site pain. On 14th August 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema, headache, nausea, influenza-like symptoms and chills. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site pain, headache, nausea, influenza-like symptoms and chills to be related to Shingrix. Additional information was reported as follows: On 12th June 2018, the patient was vaccinated with the 1st dose of Shingrix and she had not experienced any adverse events. After the injection the patient's arm was sore, but the next morning she had pain, redness and swelling at the injection site. She also had chills, nausea, flu-like symptoms and headache. The swelling had gotten to 4-5 inches in diameter. The patient saw her doctor and was instructed to ice the swelling.
Uncontrollable crying, high pitched shrieks, constant for two hours and finally she fell asleep.
Shortly after receiving the 2nd dose of Pfizer I have developed Raynaud's and extreme cold intolerance.  My hands turn bright purple and feel like they are cramping. The tops of my hands turn white and I have poor circulation.  Additionaly I feel that my average daily blood pressure has increased since the 2nd dose of Pfizer vaccine.  This Raynaud's had impacted my daily life and I am unable to go out in the cold for any length of time.  I am worried about the long term effects as well.  I never had an issue with this this before the vaccine.
Paranthesias (arms, legs, head completely "asleep" and numb for months), tachycardia, pulsatile tinnitus, uncontrolled rapid eye movement-seems similar to nystagmus,  electric shock sensation in head, body spasms- particularly in neck and head, chest pain and discomfort, shortness of breath, limb discomfort- difficulty to walk across the room, sore joints/tendons, knee pain, peripheral neuropathy, vertigo, tendonitis, temperature regulation issues, internal vibrations in brain, heaviness feeling in head, shooting sharp pain in arms/legs, burning skin feeling, blurred vision, sensitive scalp- unable to brush hair, heart palpitations, low grade fever, disconnected feeling, swollen ankles, dizziness, nerve pain especially with feet- warm water feels scalding & sometimes feels like stepping on glass, heart rate spikes when doing small tasks or taking a hot shower.  Abnormal EKG- showed short PR syndrome and possible combined atrial enlargement.  Visited Emergency room. Normal blood work.
Patient immediately felt dizzy and fainted a few minutes after getting the vaccine.  She had to lay down on the ground to prevent falling.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified number of unspecified patients were administered an unspecified number of improperly stored doses of GARDASIL (strength, dose and lot# were not reported) intramuscular. No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
Out of Temperature Range Product Administered; Initial Report Received on 06-DEC-2022  This is a spontaneous report, received from a registered nurse in the regarding a 22-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 02-SEP-2022, dose 1 of HEPLISAV B (Lot #937782, expiration date 25-SEP-2023, NDC # 43528-002-01), was administered intramuscularly in the left deltoid for hepatitis B immunisation.    The vaccine was out of temperature range. The amount of time it was out of temperature range is unknown. The reporter denied any other adverse effects reported by the patient.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
PFIZER COVID-19 VACCINE EUA. PATIENT RECEIVED HER 1ST DOSE AROUND 4:15PM.  BY 4:30PM SHE WAS ASKING TO SPEAK TO A PHARMACIST ABOUT A HEADACHE.  UPON QUESTIONING THE PATIENT, SHE HAD BEEN EXPERIENCING THE HEADACHE FOR 3 DAYS (STARTING 4/3) AND HAD TRIED A COUPLE OF OTC MEDICATIONS WHICH SHE WAS UNABLE TO NAME.  SHE COULD NOT RECALL WHAT PRESCRIPTION MEDICATIONS SHE WAS TAKING.  THE PATIENT DENIED FEELING DIZZY, CLAMMY, OR LIGHT-HEADED.  PATIENT SAID SHE WAS FINE TO WALK HOME.
Angioedema, drooling, mucosal swelling. Treated for anaphylaxis with improved exam.
Left arm was tender to the touch at the injection site. over a period of 24 to 48 hours, my left arm increasingly became red, swollen, and welted at the injection site and hot to the touch.  All complications were isolated to my left arm and on, or around, the injection site.  48 hours after the injection my arm became itchy and felt like a (severe) allergic reaction.  I felt nauseated for the first day or so and body aches the second day.  Nausea and body aches lasted no more than a day.  The allergic reaction on the injection site continues to be a problem one week after the injection.  Tenderness, swelling, and welting has improved but I am still experiencing itchiness and the site still feels warm to the touch.  The injection site reaction began within 24 hours after injection and has been ongoing for almost a week.  It was at its worst after 48 and that lasted for days (Thursday through Sunday).
Patient had non-febrile seizure about 4 hours after vaccines.  She was screaming, then stiffened.  Mom noted peri-oral cyanosis.  SHe then had generalized tonic-clonic movements for 1/2-1 minute.  After that she was pale, tired but responsive.
Little itching; Little red circle the size of nickel  at the injection site; Fatigue; vaccination site swelling; vaccination site tenderness; warm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site), FATIGUE (Fatigue), PRURITUS (Little itching), VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE PAIN (vaccination site tenderness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included INSULIN (NOVOLIN 30R [INSULIN]), GLIMEPIRIDE (AMARYL), WARFARIN SODIUM, CLOPIDOGREL BISULFATE (PLAVIX), CETIRIZINE, BIOTIN and SIMETICONE (GAS X) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site). On 06-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site). On an unknown date, the patient experienced PRURITUS (Little itching). On 13-Mar-2021, FATIGUE (Fatigue), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE PAIN (vaccination site tenderness) and VACCINATION SITE WARMTH (warm at injection site) had resolved. On 13-Apr-2021, VACCINATION SITE ERYTHEMA (Little red circle the size of nickel  at the injection site) had resolved. At the time of the report, PRURITUS (Little itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked .   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional1-The followup was received on 09 apr 2021. Patient's mail id updated. Some other events were also added. Concomitant medicines also added. Information about the second dose and its AE were added. On 12-May-2021: Additional2; Sender's Comments:  FIRST DOSE
Progressive poly peripheral neuropathy (sensory only) persistent current SX at 12 weeks. Initial severe local reaction left arm injection site.
PATIENT STATES SHE PASSED OUT THE FRIDAY AFTER GETTING VACCINATED.  SAID SHE WAS GETTING READY IN THE MORNING AND WAS ABOUT TO BRUSH HER TEETH WHEN IT HAPPENED, BUT THAT SHE WAS ABLE TO CATCH HERSELF FROM FALLING.  ALSO STATES HER ARM WAS MORE PAINFUL, SWOLLEN AND RED THAN THE 1ST SHOT.
Narrative:  Patient was intubated as a result of tongue swelling following second dose of COVID-19 vaccine. Of note, patient reported to staff he had consumes claims and chicken for dinner prior to reaction as well.
Skin hurt and very sensitive. Muscles tensed up and felt like I lost all energy. Had to be driven home and layed to rest.
On Tuesday evening I started sneezing, it lasted about 15 minutes and left me short of breath. I thought I was having an asthma attack. I took a ZYRTEC and decided I would take an at home COVID-19 test in the morning. During the night I awoke with night sweats, in the morning I was not feeling better. I took the COVID-19 test; it came back positive. I called my PCP, then I went to a local urgent care who I knew tested. They did the rapid antigen test that also came back positive. They prescribed PAXLOVID, I started taking it immediately, I awoke in the morning with just a stuffy head. For me it was like having a mild cold and it was a lot less than having flu. I did have the metallic taste in my mouth with the PAXLOVID. Today is day 6 and I tested negative with a home COVID-19 test. I did isolate as per protocol; both my husband and son have tested negative.
Patient received first dose on 10Feb2021/second dose on 18Mar2021; couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.; arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021), PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 10Feb2021/second dose on 18Mar2021) outcome was unknown and PAIN IN EXTREMITY (arm was in excruciating pain/severe pain/couldn't even touch her arm/it hurts the whole arm) and MOBILITY DECREASED (couldn't move her arm/the movement of her arm just kept getting worse/She can't reach behind her.) had not resolved.            She does not have a diagnose yet although she has consulted doctors, the X-Ray did not show injuries or anything, and they are going to do a MRI in about 4 weeks. She started going to the Orthopedist and now is doing physical therapy.  No concomitant medications were reported   This case was linked to MOD-2021-024087 (Patient Link).
Left deltoid at site of TD injection, was reddened, slightly swollen and had a 8" diameter around the site. Pt went to ER the following day (weekend), was treated with "something" to reduce swelling (according to mother).
Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment.    The outcome of the event was unknown.  The reporter did not provide causality assessment.  The case is linked to the cases 202007727, 202007728 and 202007729 (the same reporter).  Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Five reddened, raised wheals approximately 4 cm in circumference on left deltoid that remained unchanged for 3.5 days. By the 4th day, no raised areas, but skin still reddened.
This spontaneous report was  received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (orally, dose was not reported, lot # L013197, expiration date 26-Jan-2017). There was no adverse event reported. Additional information has been requested.
started breaking out in rash day prior to visit;seen in office 27JAN97 for eval & varicella dx;
Patient is unsure if hives started on 7/08/2016 or 07/09/2016. Hives on arms, legs and abdomen. Seen at hospital on 7/15/16. Treating with oral Benadryl and Hydrocortisone cream. Referred to primary care physician.
Minor rash near vaccination site about 40 mm by 80 mm vertically.  I applied Benadryl cream to stop the itching.
When I woke up the following day I had terrible inflammation in my joints and especially in my back where I have 5 different diagnosis in my back. I could barely move and I was in horrible pain! I already have severe arthritis and it was magnified greatly for 2 days.