chrisvoncsefalvay/vaers-outcomes huggingface dataset:
leg cramping; This case was reported by a pharmacist via call center representative and described the occurrence of leg cramps in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number E2A23, expiry date 13th September 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced leg cramps. On an unknown date, the outcome of the leg cramps was not recovered/not resolved.   It was unknown if the reporter considered the leg cramps to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm and experienced leg cramping that has not resolved unclear which leg involved.
about a month after receiving the vaccine I started to notice ringing in my ears.  It seems to be getting worse, not going away
Pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) 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 10-May-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. Last menstrual period and estimated date of delivery were not provided. In April 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine). On 10-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received vaccine) had resolved. Not Provided          On april-2021 patient had received first dose and on 10-MAY-2021 received second dose and denied for further follow up. No concomitant and treatment information is provided. Pregnancy information also not provided.
Pain, redness near injection site lasting 3-4 days from morning after vaccination. General fatigue and headache lasting 36 hours starting morning after vaccination.  Symptoms expected based on online information about AE?s.  Improved over time, but not completely by Day 5 (still some redness) Itching and welts (extensive) on legs, arms, stomach, back started 7PM on 30Sep2020 -5 days post vaccination.   Onset quickly - no other meds or change in food or other triggers for allergy symptoms.  Improvement by 6am 01Oct2020, but still some mild itching as of 9am.
1041: Pt c/o itchy tongue 1042: Pt states that this is how her previous allergic rxn occur and next is that her throat will close. Pt walked to ED with nursing staff x2, with epipen. Pt able to walk, talk, and no issues with breathing at this time. 1046: Pt to ed, checked in and take to a room, pt able to walk and converse with staff. At this time, pt started to become hoarse in speech and state this is when she would administer an epipen if she was at home. Epipen administered. 1047: SBAR to ED staff. Pt now in ED care.
Odd taste when eating food sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EP7534) at the age of 65 years as dose 1, single and administered in arm left, administration date 05Apr2021 14:30 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: Aug2012 (ongoing). The patient's concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "Odd taste when eating food sometimes".  Additional info: Caller stated that he had his second dose of the Covid 19 Vaccine about 3 weeks ago the day of report. He was wondering if a side effect of the vaccine can be that it effects the taste of food. Stated he had an odd taste when eating food sometimes. Patient was uncertain of when his symptoms began. Stated he believes it began after the first dose and has continued. Patient didn't have bad symptoms when he had the virus. Said he would not have known he was sick, but he knew he had been exposed so he got tested. This was prior to either dose of the Vaccine. Patient denies any other medications, medical conditions, labs, testing, or treatments relevant to event. No prior vaccinations within 4 weeks. AE  No follow-up attempts are possible. No further information is expected.
I had abdomen issues and heart issues. I have seen the GI and was diagnosis with Chronic Gastritis. I also went to see a Cardiologist and rhyme of the heart.  They put me on a heart monitor for 2 weeks.  They did an EKG as well. They want me to change my medicine.
Chills, fatigue, site of injection red and swollen, general malaise several hours after injection and subsided completely 3 days later. Symptoms 2/10/15-2/13/15.
BREATHING DIFFICULTY, STRIDOR, O2 SAT DROP, LIGHTHEADEDNESS, GENERALIZED ITCHING. AROUND 10 MIN POST INJECTION. BEENADRY 100MG TAKEN, 4 DOSES OF TWO PUFF OF PROAIR HFA TAKEN. BREATHING NORMALIZED. ITCHING REMAINED, LIGHTHEADED SUBSIDED.  GENERALIZED TOTAL BODY ITCHING CONTINUED THROUGH THE 3RD TODAY, LESSENDED YESTERDAT THE 2ND. BREATHING DIFFICULTY SOB AND TIGHTNESS RESUMED TODAY 1/3/2021 FOR ABOUT 2 HOURS BENADRYL 150 MG TAKEN , PEPCID 40 MG TAKEN, CLARATIN TAKEN PROAIR PUFFS TAKEN X 5 .  CHEST TIGHTNESS CONTINUES, ITCHING CONTINUES AND BENADRYL CONTUNES TO BE USED WITH PUFFS FOR RELIEF. NORMAL MEDS TAKEN AS WELL XYZAL AND SIGULAR
Patient was sitting in observation area after receiving vaccine.  I was contacted to talk to her because she said she felt 'dizzy'; she then said she felt 'light-headed'.  On standing she was initially unsteady on her feet, but was able to walk to emergency area, where she laid on her back with her feet elevated. Her husband was with her. 11:55:  Pulse 74, RR 16, BP 102/76, Oxygenation saturation 99% 12:05:  Pulse 64, RR 14, BP 116/78, Oxygenaton saturation 99% 12:15:  Pulse 58, RR 14, BP 118/74, Oxygenation saturation 99%  After 12:05 vital signs, patient stated she had no dizziness and felt like her 'usual self'; at that time she sat up, was talking with her husband and myself and appeared stable.  After the 12:15
left foot began itching around the end of may and at same time. then  calves, thighs, upper arms, hands and it would happen to both sides at same time . when it reached top of shoulder after a few days it all went away.
lump, bigger than a pea but smaller than a marble on the left side above the collarbone; rash on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) and RASH (rash on the chest) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 011M20A) for an unknown indication.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) and RASH (rash on the chest). At the time of the report, NODULE (lump, bigger than a pea but smaller than a marble on the left side above the collarbone) outcome was unknown and RASH (rash on the chest) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Ultrasound scan: inconclusive (Inconclusive) Inconclusive.         No concomitant medications were reported.   Patient consulted their dermatologist and was given an unspecified cream. An ultrasound of the lump was performed and the patient was urged to have a CT scan performed following the results.
UC flare; This is a literature report.  Introduction: The advent of mRNA vaccines has been a major component of the vaccination effort against COVID-19. Immunization with mRNA vaccines has been associated with a systemic inflammatory response. We present two cases of patients with ulcerative colitis (UC) in long-term remission who experienced flare following vaccination.   Case description/methods: Patient 2: A 52-year-old female with history of UC in remission of 5 years on mesalamine who received both doses of the BNT162b2 mRNA vaccine, 21 days apart, presented with abdominal pain, diarrhea, and bloody stool that developed 1 day after dose 2. Abdominopelvic CT demonstrated diffuse colitis, and she underwent colonoscopy, which was aborted due to extensive colitis. Sigmoid colon biopsy confirmed crypt abscess formation architectural distortion and ulceration. She was treated with mesalamine and methylprednisolone. Her acute disease was complicated by bowel perforation, and she underwent total colectomy.  Discussion(s): The presence of an environmental trigger is frequently linked to onset of disease flare in patients with UC. These two patients were in symptomatic remission on 5-ASA maintenance agents for several years prior to vaccination. The lack of clear alternate environmental changes in these patients suggests provocation of flare by the inflammatory response following vaccination. Existing literature evaluating SARSCoV- 2 mRNA vaccine adverse-events in patients with UC suggests that gastrointestinal side-effects are uncommon. In addition, biologic agent use may decrease rate of vaccine- elated adverse events. Recommendations from an expert consensus favors vaccination of patients with UC. In addition, recent literature demonstrates strong immunologic response following vaccination of patients with UC despite concurrent use of biologic agents. Consideration should be given to pretreatment of patients with UC in remission to decrease risk of flare.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Ulcerative colitis relapse and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Arm was very very sore; Aching all over my body; Chills; 98.2.F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was very very sore), PAIN (Aching all over my body), CHILLS (Chills) and PYREXIA (98.2.F) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L2DA and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was very very sore), PAIN (Aching all over my body), CHILLS (Chills) and PYREXIA (98.2.F). At the time of the report, VACCINATION SITE PAIN (Arm was very very sore), PAIN (Aching all over my body), CHILLS (Chills) and PYREXIA (98.2.F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 98.2 98.2F.         No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-230884 (Patient Link).
Beginning with right arm pain after injection, and the day after with slight bruising to the injection site. Then after eight days a rash appeared just below the injection site with slight swelling and itching.
About 12 hours later patient could not move his legs and could not walk. With assistance of wife and walker could barely get to the bathroom. Describes it as "could not make his legs work". The next morning (Saturday morning) it was better and he could walk with the assistance of just a walker.  This also happened after his second shot which was Pfizer Lot: EN6201 on 3/11/21 at the same Pharmacy. Patient provided this information while receiving his booster Pfizer dose today 10/25/21. He had not previously reported to the Pharmacy or VAERS.
Headache; Fever; Joint Ache; Chills; Flu Like Symptoms
Muscle pain starting that night after the shot, fever of 99.6 the next day, fatigue, headache, and muscle pain all over, took advil and slept most the 2nd day. 3rd day only mild muscle aches
At about 9:30 pm on 3/25, left arm started getting sore and felt a rush of warmth in the crook of my elbow on the same arm.  Went to bed.  During the night felt ill, but didn't do anything about it.  On 3/26 at around 7:00 am, when I usually awake, I couldn't really get out of bed because of fatigue, slight headache, and nausea.  No temperature, but took 2 tylenol around 10 am.  Woke up about 11:20 am feeling better and ate.  Started feeling more tired at about 1:20 pm; rested and slept.  Started getting chills and more fatigued; 102.4 degree temp at 4:00 pm, 101 degree temp after taking tylenol.  Friday night sweat through two pj sets.  Woke up Saturday with no temperature, but tired and short of breath.  Shortness of breath has continued through today, April 1, although better than Saturday-Tuesday.  Shortness of breath occurred when walking, going up stairs, and talking.  O2 level dropped no lower than 94%, 96% when resting.  Usually, its 98-99%.
Patient reported that she received Zoster vaccine and developed redness around the site of injection.  She reported that three weeks after receiving the vaccine she developed back pain and was seen and evaluated by a doctor for this.  She never broke out in a rash, but had nerve pain in the back.  She was diagnosed with the Shingles and was given Valtrex for one month and tyelenol with codeine for pain relief.  She has been on the Valtrex for one week at this time and is still in pain.
I started with bad rash day after shot.. 2 days later I started breaking out in hives.. as the day went on i started breaking out all over my body especially my face. my legs, back, face, stomach.. itchy everywhere.
Severe lightheadedness and fluid accumulation at site of injection from being swollen.; Severe lightheadedness and fluid accumulation at site of injection from being swollen.; Severe lightheadedness and fluid accumulation at site of injection from being swollen.; This is a spontaneous report from a contactable consumer or other non hcp(Patient himself). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 09:15 (at 35-years-old) (Batch/Lot number UNKNOWN) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient experienced severe lightheadedness and fluid accumulation at site of injection from being swollen on 03Feb2021 19:00. Therapeutic measures were taken as a result of severe lightheadedness and fluid accumulation at site of injection from being swollen which included ice packs. The outcome of events was reported as not recovered.  Information on the lot/batch number has been requested.
Felt a faint pain behind my left breast around 30 minutes after receiving the vaccination. I also got the vaccine on my left arm. The dull or faint pain is not constant and I will randomly feel it since receiving the vaccine. This is some thing that I have experience in the past when I have had too much caffeine but in the past it was more prominent whereas right now it?s very light and faint and dull
Tinnitus mostly in left ear, coming and going on right. Gradual onset around a week after the shot. Ear and throat pain. Difficulty popping ears. I went to the doctor and she gave me flonaise which has helped with the popping but not the sound. It?s a high pitched screeching. Please help.
Fever, chills ,headache, body aches, nauseousness, arm soreness, increased heart rate, sharp pain in head, exhaustion.Body aches, headaches, exhaustion still experiencing. All other symptoms lasted a day. Took Advil and Tylenol.
APAP given w/in 1 hr of administration of vax, then same dosage given q 4-5 hrs for total of 3 doses; last dose given 4AM 17JUL91, fever began 15JUL91 103 R in ER 8AM on 16JUL91;
Pregnancy; Initial Report Received on 09-Dec-2022 (Safety received 14-Mar-2023)   A nurse reported to the Registry that a patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when 25 weeks pregnant.  No relevant medical history was reported.    No relevant concomitant medications were reported.    08-Dec-2022, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported). The route and site was not provided. The patient was 25 weeks pregnant.  The nurse was calling about enrollment, but the patient only speaks another language, so the nurse was asking for options. The registry staff asked the reporter if they could call her back with options after speaking with a manager. The patient may not be able to be consented if she does not understand as is not translated.   The Pregnancy Registry attempted to several follow-ups on 12-Dec, 19-Dec and 29-Dec-2022 with the reporter on whether the reporter would enroll the patient de-identified and left several messages to return the call. Follow-up with the patient was not obtained.  No additional information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient given 0.5 mL pediatric dose of Havrix. Error noted after patient had left the office and we were unable to give her the additional 0.5 mL needed for a full dose.
Vesicular Eruption 8 days after vaccine administration, low grade fever(subjective). Resolved 4/21/2018.
Within about 12 hours after taking the vaccine a capillary in the white part of my eye bust and the left side of my left eye was/is bloody; It's been about 2 days and for the first day and a half I experienced the normal flu like symptoms.; dazed; when I leaned back to put eye drops in eye I lost my balance a little which does not normally happen; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534), via an unspecified route of administration, administered in left arm on 27Mar2021 14:30 at single dose for COVID-19 immunisation. The patient's medical history included asthma, prediabetic, low thyroid, overweight but not obese, and capillary in the white part of his eye bust (right eye) about 4 months ago. The patient's concomitant medications included alprazolam (XANAX), colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and levothyroxine sodium (SYNTHROID). The patient previously took cryproheptadine hydrochloride (CYPRO) and had known allergies. The patient also previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient had no COVID prior to vaccination and has not been tested for COVID post-vaccination. The vaccine facility type was Public Health Department. The patient has no other vaccine in four weeks. On 29Mar2021 at 14:00, it's been about 2 days and for the first day and a half, the patient experienced the normal flu like symptoms. Now after about two days (29Mar2021 at 14:00), he feel just a little out of it, dazed. Also when he leaned back to put eye drops in his eye, he lost his balance a little which does not normally happen. Also within about 12 hours after taking the vaccine, a capillary in the white part of his eye bust and the left side of his left eye was bloody. No treatment was received for the events. The outcome of the events were not recovered.
Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nasal congestion.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 10-Jan-2021, NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; Reporter'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.
Pt had a spontaneous brain hemorrhage,  leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later.
Day 1 - arm soreness, Day 2 - Fatigue and face numbness and tingle Day 3 - Face numbness and tingle followed by droopy right eye and then right sided mouth drooping that comes and goes.
pt recvd vax 29NOV93 & w/in 24 hrs mom stated pt had fever to 104 & 2 episodes of major muscle spasms lasting several seconds each poss sz; fever resolved; approx 24 hrs later; not seen by MD; trembling of whole body lasting 10-15 sec;
pt recv vax & exp blurred vision & aching of both eyes;30SEP97 (7 days post vax)  vision in lt eye had returned to baseline but vision in rt eye was cont to deteriorate;corrected vision in rt eye was 20/50 & 30SEP;dx optic neuritis;
Blood clot in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Apr-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 06-Apr-2021 due to THROMBOSIS. The patient was treated with Surgery (Angioplasty) for Thrombosis. On 06-Apr-2021, THROMBOSIS (Blood clot in leg) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the stat date of the events a causal relationship cannot be excluded.
patient fell unconscious a day after the vaccination. Was in the hospital for 3 days and took 2 days to completely regain consciousness