chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Around Sep 1, 2021  I developed severe pain and swelling on my left foot around my thumb, I went to a foot doctor  who incorrectly diagnosed it as gout disease, he treated it with Motrin and after a while it went away.  Around Jan of 2022 I developed severe pain in my right elbow which greatly limited the use of my right Arm, my Doctor diagnosed it as Tennis Elbow, I never play tennis or any sport, I also do not use my hand in a manner that would typically cause tennis elbow, I was prescribed PT twice a week which has helped    Around March 2022 I developed pain in my left foot around the ankle area, this greatly effects the way a walk and caused me to develop a slight limp.
17 YEAR OLD received Moderna. It was realized when she came back for her 2nd Moderna vaccine on 6/4/20201.
A burning sensation on areas touching any surface. Mostly felt in the back and buttocks. Continues since May. A rash on buttocks still exist today. Have seen 3 doctors/ no diagnosis. Prescribed treatment is Gabapentin 300 mg 3 times daily. Unable to sit or lay down comfortably.
pt recv vax; approx 4 hr later, devel hives; no problems at site of inject;
2nd dose was given too early by 5 days. At time of immunization no apparent side effects. Pt contacted and advise to return in 28 days.
Lots of fatigue 2 days after vaccine, sharp stabbing pain on left side that afternoon underneath breast, struggling to breathe, went to ER, ER thought it was blood clot in lung, found to have normal lung, take ibuprofen, pain lasted most of the day, more pain when breathing in, pain gradually faded but occasionally flared up for 2 weeks after the first adverse event. Had been having some mild symptoms previous to that, medical people concluded it was inflammation exacerbated by vaccine. Palpitations, rapid heart rate.
Upset stomach; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included Upset stomach. Concurrent medical conditions included Lactose intolerant.    On 23-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 4:00 AM, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue). On 26-Apr-2021, ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details were reported.  Patient  is taking Concomitant  medications since 01-01-2018. Following are the details : 1) Multivitamin (1 per day) - oral route, indication - To be healthy. 2) Calcium ( 300mg/1 per day) -  oral route, indication  -  Extra calcium  because I am  lactose intolerant. 3) iron (65mg/1 per day) - oral route, indication - Anemic. 4) Flaxseed Oil (1000mg/1 per day) - oral route, indication - Dry Eyes.   This case was linked to MOD-2021-314027 (Patient Link).
Hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hives) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-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 URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
recently tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (recently tested positive for covid) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SARS-COV-2 TEST POSITIVE (recently tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (recently tested positive for covid) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced non-serious event of special interest SARS-CoV-2 test positive. The event occurred following the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. Furthermore, information regarding vaccination schedule and first and second dose was not provided. Also, no information about patient's accompanying symptoms has been provided at this time. The rechallenge is not applicable considering that the event occurred following the third dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-CoV-2 test positive is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced non-serious event of special interest SARS-CoV-2 test positive. The event occurred following the third, booster dose of mRNA-1273, however, the precise temporal relationship cannot be determined, having in mind that the exact start date of the reported event was not provided nor was provided vaccination start date. Furthermore, information regarding vaccination schedule and first and second dose was not provided. Also, no information about patient's accompanying symptoms has been provided at this time. The rechallenge is not applicable considering that the event occurred following the third dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for SARS-CoV-2 test positive is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Shoe was swollen up/swelling is in his lower left: ankle, foot, and leg; Pelvis was also swollen; Rash between fingers; Lymphadena; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Shoe was swollen up/swelling is in his lower left: ankle, foot, and leg), SWELLING (Pelvis was also swollen), RASH (Rash between fingers) and LYMPHADENOPATHY (Lymphadena) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy, VITAMIN B COMPLEX for Supplementation therapy, VIT D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PERIPHERAL SWELLING (Shoe was swollen up/swelling is in his lower left: ankle, foot, and leg), SWELLING (Pelvis was also swollen), RASH (Rash between fingers) and LYMPHADENOPATHY (Lymphadena). The patient was treated with IBUPROFEN at a dose of 200 mg; Physical therapy (Compression bag physical therapy to reduce swelling in foot from lymphedema) for Peripheral swelling and Physical therapy (compression bag physical therapy) for Lymphadenopathy. At the time of the report, PERIPHERAL SWELLING (Shoe was swollen up/swelling is in his lower left: ankle, foot, and leg), SWELLING (Pelvis was also swollen), RASH (Rash between fingers) and LYMPHADENOPATHY (Lymphadena) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Computerised tomogram: abnormal (abnormal) left superficial inguinal lymph node is minimally prominent, measuring up to 2.8 cm, but still maintains its normal fatty hilum.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-074901 (E2B Linked Report). This case was linked to MOD-2021-074901 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Additional information received; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074901:1st dose
Isolated pox developed on right foot 09 Aug 09, likely focal auto inoculation (vs localized vaccine).
Pt recvd vax 22NOV93 930AM & devel h/a, sore arm by 3AM throat very sore felt closed was seen by MD dx w/URI;
Information has been received from a pharmacist and a physician concerning a patient who in August 2007, was vaccinated with a dose of RECOMBIVAX HB. In approximately August 2007, the patient developed a rash on the trunk and arms 24 to 48 hours after vaccination. The physician was then notified and described the rash as a hypersensitivity rash. The physician did not describe other symptoms or treatment. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
nausea, body chills, parts of face felt numb & tingly; also sore throat;
arm was so sore to the point that she could not lift her arm to put on a T-shir; she experienced arm soreness/arm was so sore; felt very tired; blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021), MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN for Diabetes, SEMAGLUTIDE (RYBELSUS).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021). On 10-Feb-2021, the patient experienced MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugars have been elevated/having trouble with my sugars\Blood sugar was 175 on 11feb2021) had not resolved and MOBILITY DECREASED (arm was so sore to the point that she could not lift her arm to put on a T-shir), VACCINATION SITE PAIN (she experienced arm soreness/arm was so sore) and FATIGUE (felt very tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood glucose increased: (Inconclusive) morning-141 night-167. On 10-Feb-2021, Blood glucose increased: (Inconclusive) morning-170 night-173. On 11-Feb-2021, Blood glucose increased: (Inconclusive) morning-175. On an unknown date, Blood glucose increased: (High) Patients normal sugar-126-130.         Treatment information include one additional metformin.  Action taken with mRNA-1273 in response to the events was not applicable.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On the date previously entered I experienced full body fatigue suddenly and decided to lay down.  About 20mins later I went to stand and when I lifted my legs they began to shake and felt weak. This weakness slowly got better over the next 4-5 hours. 2 days later I was working and I had the muscle weakness again. Today 01/19/2021 I had another episode of weakness, it is primarily in my legs and they shake if I attempt to lift them.
Redness at site of injection.  We were informed by primary care physician that this patient developed a mild disseminated blistering and was seen by a dermatologist.
SLEEPINESS; KIDNEY HURT; LOSS OF APPETITE; COUGH; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042421A, and expiry: 21-JUN-2021) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced sleepiness. On 02-APR-2021, the subject experienced kidney hurt. On 02-APR-2021, the subject experienced loss of appetite. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, cough, and chills on 02-APR-2021, and had not recovered from headache, sleepiness, and kidney hurt. This report was non-serious.
Hives , swelling of left ear & eye. Extreme Muscle pain mainly in neck and arm right side and muscle pain  throughout my body.
Large red area surrounding injection site that that has grown is swollen and hard and sensitive to touch-also, extreme itching at injection site and soreness
Chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported. treatment details were not reported.   This case was linked to MOD-2021-041137 (Patient Link).
defective needles caused some of the dose to drip out. patient did not get full dose.
A few mins after 1st shot on 3/9, pt. felt "warm" w/increased heartrate and lightheaded.  BP 156/114, pulse 122.  In a few mins BP improved to 114/72.  Pt. was advised to f/u w/her dr.  for BP eval.  On 3/18 she noticed itchy rash over injection site w/"nerve" pain and swelling of whole left arm down to her fingers.  Went to Urgent Care 3/19 and got a sling and a course of steroids.  Saw her dr. 3/23, was improving by then. No additional treatment.  She stayed off work 1 week.  On 3/30 had 2nd Pfizer vax right arm; had chills, fever, joint pain that night, resolved next day.  States is mostly recovered now except for minor swelling and pain in left arm.
Confusion and memory loss.  Lasted about a week.  Very obvious to me and to those around me.
Pt arrived at 1247 reported "tonsil swelling" which progressed to tongue feeling thick. Benadryl 25 mg IM given at 1252 without relief. Pt still reporting feeling of tongue swelling. Rash developed on neck and arms.  Per protocol second dose of Benadryl  25 mg administered with slight relief at 1315. Epinephrine 0.3 ml administered at 1315 with no relief. Symptoms still persist. Second epinephrine dose administered at 1322.  EMS notified and arrived at 1329 to transport pt to Northwestern Hospital.
large, swollen arm; This case was reported by a other health professional via sales rep and described the occurrence of large arm swelling in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced large arm swelling. On an unknown date, the outcome of the large arm swelling was unknown.   It was unknown if the reporter considered the large arm swelling to be related to Bexsero.  Additional details were provided as follows: The patient had large swollen arm after receiving the Bexsero vaccination.  No additional details were available. The reporter consent to follow up.
Difficulty breathing, hoarse throat/voice, weakness/fatigue and an increased heart rate, coupled with other flu like symptoms Increased urination although I had hardly taken in any fluids after 11:00 Great deal of pressure in my head and sinus cavities. I had an extreme amount of pressure in my eyes. My eyes were blood shot and watery for the remainder of the day as well as the following day. I had fever and chills as well. symptoms didn't subside until around 6 pm on Thursday.
Redness and swelling in arm at and around injection site. The redness and swelling wrapped all the way around patients arm. we have had about 3 other patients have similar reactions with this vaccine with the same lot number.
patient received a dose of ACTHIB which was reconstituted with sterile water; Initial information was received on 04-May-2021 regarding an unsolicited non-valid non-serious case from other health professional (inquiry number: 00587326).  It was reported that 0.5 mL of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ357AA and expiry date not reported) was administered to a one-year-old male patient which was reconstituted with sterile water via an unknown route at an unknown administration site for prophylactic vaccination (product preparation issue).  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Heachache, nausea, fatigue within first 5 days; then rash started 8 days later.
Round, red, raised, and hot area around injection site that was extreamly soar to the touch and felt like a burn. The are that was affected also was very sore and it hurt to move for 3 days post vaccine. I was a little achy all over too. The red spot went away after 4 days. Then 8 days post vaccine the red, raised, round spot that is hot to the touch came back. The soreness has also returned.
A few hours post vax the patient showed symptoms of apnea with periods of shaking of 15-30 seconds. The patient seemed "out of it".
ARM WHERE THE SHOT WAS GIVEN WAS SORE TO THE TOUCH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced arm where the shot was given was sore to the touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm where the shot was given was sore to the touch was not reported. This report was non-serious.
Expired ROT ATEQ administered to patient.; This spontaneous report was received from an other health professional referring to a 2 month old male patient. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.     Between 10AM to 11AM on 20-NOV-2020, the patient was vaccinated with expired rotavirus vaccine, live, oral, pentavalent(ROTATEQ)  (dose, strength, and anatomical site of vaccination were not reported, lot # S006159, expiration date reported and validated as 10-NOV-2020) orally for prophylaxis (expired product administered). The outcome of expired product administered was unknown.
7 year old patient accidentally received a dose of TDaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number U7549AA) for prophylaxis.   On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 year old patient accidentally received a dose of TDaP).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 22-Aug-2023 Pediatrician called in to report that a 7 year old patient accidentally received a dose of TDaP but was unsure if the product was actually a GSK product. During the call, the conversation was suspended due to a connectivity issue A call back was made but the health care professional (HCP) did not answer. The 7 year old patient Boostrix, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Patient should have received Pfizer 0.3ml (12+) but instead received Pfizer 0.2ml (5-11 year old)
Noticed quarter sized redness to injection site in the morning upon waking, progressed to about 6cm diameter indurated area with warmth to touch by the afternoon.
After the 1st shot, I was fine. I just had a sore arm. I got the 2nd shot at noon (on Monday) and decided to go home in case I started to fell bad. I didn't feel bad that afternoon, evening, or night. I went to work on Tuesday. As the day progressed, I felt really cold and tired. By the time I got off of work, I was absolutely freezing and felt like I could sleep for days. I took my temperature and it was 100.4. I took more Ibuprofen and went to sleep for 3 hours. I woke up and took my temperature again and it was 99.4. I took more Ibuprofen and went back to sleep. I slept all night (which is uncommon). I felt fine on Wednesday.
Patient contracted COVID after being fully vaccinated.  No Booster Fatigue and Runny nose
Immediately after vaccine -> lightheadedness with 23 hours -> fatigue, HA, abd ache, loose stool 9/25/15 - persistent HA, nausea, neck pain advised hydration, rest 10/1/15 - "hand and finger swelling" reported, difficulties with concentration.