chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been experiencing intermittent, involuntary twitching of my my left thumb that started around 12;00 noon. There is no numbness or tingling (normal injection site ache, however) or recognizable pattern of when the twitching occurs, and the twitching does not seem to last longer than 10 seconds at the most before stopping. 1-3 minutes will pass before my thumb starts twitching again. Other digits do not seem to be affected. I did not experience this prior to the COVID-19 vaccine administration and not have any neurological conditions that this would be a symptom of.
allergic reaction; feeling sick; Feels lousy; can't breathe; arm has been painful, tender; arm swollen; dizzy; weakness; shaking; didn't get of bed for 2 days and she just can't function; can't even think; feeling  hot and  cold; hands and feet are cold and just can't get warm; sweaty; heartbeat is racing; lethargic; fever; redness; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe) and PAIN IN EXTREMITY (arm has been painful, tender) in a 68-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.     The patient's past medical history included No adverse event.   On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (allergic reaction), MALAISE (feeling sick), FEELING ABNORMAL (Feels lousy), DYSPNOEA (can't breathe), PAIN IN EXTREMITY (arm has been painful, tender), PERIPHERAL SWELLING (arm swollen), DIZZINESS (dizzy), ASTHENIA (weakness), TREMOR (shaking), HYPOKINESIA (didn't get of bed for 2 days and she just can't function), THINKING ABNORMAL (can't even think), FEELING OF BODY TEMPERATURE CHANGE (feeling  hot and  cold), PERIPHERAL COLDNESS (hands and feet are cold and just can't get warm), HYPERHIDROSIS (sweaty), PALPITATIONS (heartbeat is racing), LETHARGY (lethargic), PYREXIA (fever), ERYTHEMA (redness) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided   Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-053149 (E2B Linked Report).; Sender's Comments:  MOD-2021-053149:First dose
The vaccine was received after more or less 24 hours after delivery and noted the box is still cold but the gauge is beginning to turn red with no reported adverse event; Initial information received on 10-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced the vaccine was received after more or less 24 hours after delivery and noted the box is still cold but the gauge is beginning to turn red with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (strength, dose and formulation: unknown) with lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious "the vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red with no reported adverse event (intercepted product storage error)" (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported that "client called to check viability of vaccine as he was told the vaccine was ordered 31/Jan/2022 and arrived 01/Feb/2022 not even within 24 hours after it was ordered. The vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red. Account manager cannot provide information on the worst case lowest or highest temperature and duration of the excursion".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (The vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red with no reported adverse event).  At time of reporting, the outcome was Unknown for the event the vaccine was received after more or less 24 hours after delivery and noted the the box is still cold but the gauge is beginning to turn red with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Diffuse lenticular rash noticed approximately 16 days following administration; local induration at site of MMR noticed approximately 12 days following administration.
After approximately 10 minutes Pt started clearing her throat repetitively and complaining of chest pain, shortness of breath and tingling/swelling if her tongue. Pulse Ox was taken and Pt was at 97% on room air and pulse of 84. 1st dose of Epi 0.3 mg given IM in left thigh at 1156, followed by IM injection in left thigh of Benadryl 50 mg. Pty placed on 2L O2 by nasal cannula. Lungs clear, Pt was not stridulous. EMS called and arrived at 7 minutes after injection of Epi. Pt transported to ED via ambulance, departed without incident.
73 y.o. female with past medical history of stage 4 melanoma (currently on  encorafenib/binimetinib) presents with complaint of abd pain that started 2 days prior to admission (adm on 11/13/21). Her pain is described as epigastric/RUQ/RLQ abd pain with associated nausea and multiple dry heaving with clear fluid since yesterday and no diarrhea. Reported fever at home up to 100 but denies chills. Normal BM per pt (solid and brown, non-bloody), denies bleeding. Denies CP/SOB, cough, dysuria. Patient received her Moderna vaccine booster on 11/5/21. Reports last colonoscopy ~ 10 yrs ago that was reportedly normal.  CT abd was done on admission that showed Marked mural edema involving the transverse colon, with relative sparing of the distal transverse colon and splenic flexure region. Findings are consistent with colitis and could be related to infectious or inflammatory colitis. Ischemic colitis should also be considered.  She was seen by GI, general surgery and oncology, appropriate w/up was done - not felt  related to cancer immunotherapy nor infection.  CT abd mesenteric protocol was done 11/15/21: 1.  Persistent mural edema involving a long segment of the mid transverse colon, slightly improved in the interval. There is induration of the paracolic fat. There appears to be enhancement of the edematous bowel wall; however, the enhancement does appear relatively diminished; although difficult to assess due to the still fairly pronounced bowel wall edema. No vascular occlusion is identified. Ischemia due to low flow states cannot be excluded on the basis of this exam and may be intermittent; therefore, clinical correlation is recommended.  Pt's BCx remain negative and has intermittent low grade fevers,  had firm BMs (no diarrhea), was covered with antibiotics but etiology of her transverse colitis remained unclear and thought to be vaccine related.
1. A very sore feeling inside of my right nostril that developed into an actual wound about two days after the vaccine on 3/5/2021. It has only just started to heal and feel "normal" as of 3/24/2021.  A strange cold sensation just to the right, lower side of my right eye. Every time my eyes well up, crying or just tearing up after yawning etc., I have a cold shooting sensation that begins at the corner of my eye and moves down my face about and inch. It's so cold and intense I always reach up to feel if I somehow have a tear on my skin already, but never do. This occurs whether tears actually leave my eye and move down my face, or even if I just tear up. It start occurring roughly two days after my first Covid-19 vaccine on 3/5/2021. My second shot is scheduled for 4/2/2021
Sore arm, GI reactions, diarrhea 48 hrs. Then it went away.
Starting at 2 am after vaccine Severe headache, nausea, diarrhea, muscle aches, right arm pain, fever, sweating, bilateral eye pain
Patient had vaccine at aproximately 940 m. She came back into walk in clinic around 1 pm stating  she had developed total body rigors, slurred speech, gait disturbance and left sided chest pain. Patient was sent to ER for further evaluation
CHICKEN POX TYPE RASH ALL OVER BODY, ARMS, LEGS, TRUCK, BACK
rash on my upper left arm where I received the vaccine.; fatigued; vaccinated arm sore; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching). At the time of the report, VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 06-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history information was reported.     On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching). At the time of the report, VACCINATION SITE RASH (rash on my upper left arm where I received the vaccine.), FATIGUE (fatigued), VACCINATION SITE PAIN (vaccinated arm sore) and PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
After 1st vaccine I developed a very sore arm w a lump under my skin the size of a tennis ball.  This was a Thursday by Monday it subsided. By the end of the 1st week, the site of the vaccine is very red about 2 inches in diameter and the lump is back w tenderness returning.
Temp 100.4 one day after receiving vax, then no sx until 3/15/2000 nightly fevers - temp not taken but child was burning up with fever. Tx with Tylenol. Slight dots and blotches on genitalia, buttocks and stomach started approximately on 3/19. Has had similar sx before with teething. Now rash is spreading. No fever or rash since 3/24/2000.
Swelling/ redness < 24 hrs after administration of HEP A vaccine right upper arm/ warm compresses TYLENOL PRN
Information has been received from a physician concerning a 10 year old female who on 21-JUN-2001 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 30-JUL-2003, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 20-NOV-2009, the patient experienced mumps (the date diagnosed was reported as 03-JAN-2010). The patient was afebrile and did not have parotitis. The outcome for mumps was not reported. Follow-up information was received from the physician concerning the 10 year old female patient (also reported as 8 years old). It was reported that the mumps onset date was 14-JAN-2010 (previously reported as 20-NOV-2010)/. The patient was diagnosed with 17-JAN-2010 (previously reported as 03-JAN-2010). The patient had right parotitis. At the time of reporting the patient's final outcome remained unknown. This is one of several reports from the same source. No further information is available.
Received shingles vaccine- ZOSTAVAX- Resulting in break out of shingles.
ANGINA, UNSPECIFIED ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN HYPOTENSION
This spontaneous report was received from a female consumer of unknown age refers to herself. The consumer's medical history, concurrent conditions and concomitant medications were not reported. In November (year not specified), the consumer was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). In May (year not specified), the consumer experienced shingles after the vaccine. The outcome of the adverse event was unknown. The relatedness between the adverse event and the vaccination with ZOSTAVAX was not reported. Additional information is not expected, no reporter contact details.
severe chills moderate to severe head ache moderate to severe body ache moderate to severe nausea
(L) upper arm swollen and red warm to touch and c/o itchy. BENADRYL 25 mg IM given today. 13 cm x 13 cm area.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (patient received 1st dose of Shingrix, refer case US2020AMR003744.).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had pain in arm. This case linked US2020003254, reported by same reporter.
Both doses I had a headache, nausea, fatigue and some dizziness but nothing to severe. I have an IUD (my  3rd) and haven?t had a period where I bleed in about 6yrs. After the second dose I have had 3 period cycles where I have actually bled, it is still less than prior to an IUD. Also while I have had cramping over those 6 years they got significantly worse for the last 3 cycles. Also just had a gyno appointment and they said my IUD is still in a good position and there are no other underlying issues.
he was in atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (he was in atrial fibrillation) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (he was in atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (he was in atrial fibrillation) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  Patient experienced atrial fibrillation one week after receiving the second dose of the vaccine.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
a 46 year old patient / received a dose of Shingrix on 27Jan2021; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 45-year-old female patient who received Herpes zoster (Shingrix) (batch number 295J3, expiry date 6th December 2021) for prophylaxis.   On 27th January 2021, the patient received the 1st dose of Shingrix. On 27th January 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The Pharmacy intern reported a 45 years old patient received dose of Shingrix vaccine, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZCA) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 25-Jan-2021, VACCINATION SITE PAIN (Soreness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment details was provided
This spontaneous report as received from a pharmacist refers to an approximately 59 year old non-pregnant female patient with high blood pressure. On approximately 31-JUL-2014 (about two weeks ago) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot #, expiration date unspecified), subcutaneous. Concomitant medication included blood pressure medications. In 2014 the patient developed disorganized, bilateral rash on arms, neck and face. The pharmacist stated that the patient reported itching and pain with the rash, and that the lesions crust when they resolved. The patient had sought medical attention. The pharmacist stated that the patient was prescribed a "steroid cream" by her physician, but it had not brought the patient relief. The pharmacist stated "I think it looks like chicken pox". She stated that the patient reported having no history of chickenpox. The event outcome was reported as not recovered. Additional information has been requested.
The patient states two days after each vaccine she developed a rash and hives. After the second vaccine the patient went to the ER with hives all over her body and face, and difficulty breathing when sleeping. ER doctor states the patient either received too much vaccine or it reacted with her system.
On October 8th, 2022 the patient was given a vaccine with the expiration date of 09/30/22.  I was notified of the error.  We were also notified that the manufacture indicates the the stability data supports the use of the product through October 19 and that revaccination is not required.
This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age or gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 31 Fahrenheit degrees (F) range for a time frame of 48 hours. The temperature excursion was not recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. No information on patients' pertinent medical history, drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were vaccinated with a doses of VAQTA (dose and route were not reported) (lot # M018644, expiry date 20-SEP-2017) that were improperly stored. Concomitant therapies were not provided. No adverse effects were reported. This is a one of several reports from the same reporter source. Additional information has been requested.
She received vaccine and was sitting waiting for 15 minutes.  After 10 minutes she came over and expressed that she felt dizzy and was about to pass out.  We took her over to bed where she was extremely nauseous and dry heaving repeatedly. She was also extremely flushed and hot but no temperature and no problems breathing.  Blood pressure was elevated when ems came.  We called 911 and had a Dr. who was at clinic check on her.  Ems came after about 10 minutes and took her to hospital.