chrisvoncsefalvay/vaers-outcomes huggingface dataset:
depression; diarrhea; dizzy; headache; vomit; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy), HEADACHE (headache) and VOMITING (vomit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included ATENOLOL, LEVOTHYROXINE, CLOZAPINE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy), HEADACHE (headache) and VOMITING (vomit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency. On 10-Jun-2021, VOMITING (vomit) had resolved. At the time of the report, DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up was received No new information
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of VAQTA (dose and lot # not reported) after the vaccine was exposed to temperatures outside of recommended condition. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Within 20 min to half hour after this first vaccine dose I  experienced sharp one second pains in what felt like uterus.  Happened intermittently several times through day and faded away after 1st day.  Also within half hour of vaccine both arms felt asleep or as if they had been in same position for a long time even though they were not.  This continued first day or longer off and on.  Within first half hour after vaccine experienced a brief one second strong headache in small section at back of head.  On drive home after vax and first days my heart hurt.  Brain for for first week.  Worst affect was in days 6 and seven post first vaccine experienced moderate to severe continual headache.  Lasted 2 to 3 days.  I never get headaches like this.  I did also experience sore breasts and mood swing as if my period was coming but it was not due to come for another 9 days.  This is unusual for me as it usually only happens briefly the day before it starts now.     My period did start on time on schedule 17 days after the vaccine.   Also I had a weird thing happen on one day in which my earlobe itched and felt infected as they did many decades ago when I was allergic to metal from earring posts in my pierced ears.
Extreme tiredness, dizzyness, low energy, overall feeling of malaise. I slept a lot. This is day six from when adverse reaction began and I feel almost normal, but I still have a little dizzyness. I was so dizzy one day that I would have fallen if I had not grabbed the doorframe.
14NOV90 pt vax w/2nd hep B; exp gen hives; Sx resolved.  Felt warm, had flushed skin on face & arms w/o wheezing, tachycardia, blood pressure of 130/90.  Tx w/ benadryl.  Sx resolved.
Information was received from a 67 year old female consumer who was given PNEUMOVAX 23 (Merck), unknown dose and frequency, about two weeks ago (approximately 01SEP2012). Her relevant medical history included high blood pressure and she may have received the pneumococcal polysaccharide vaccine a few years ago, but was not sure. The patient's relevant concomitant medications included MYSOLINE, aspirin 81mg, atorvastatin, LYRICA, benazepril and an unknown antibiotic (unknown indications). Two weeks ago (approximately 01SEP2012), the patient experienced abdominal pain. Five days ago (approximately 09SEP2012), she broke out with a rash and itching on her face, arms,  ears and eyes. She had normal blood test and x-ray (not further specified) two weeks ago (approximately 01SEP2012). As of 14SEP2012, the outcome of the abdominal pain, rash and itching was unknown. Additional information has been requested.
Mouth rash, mostly under tongue some around lower molars; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 11:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. The patient had no known allergies. On 16Apr2021, the patient experienced mouth rash, mostly under tongue some around lower molars. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event mouth rash was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 03-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Received first injection 1 weeks ago. The first few days I experienced normal symptoms such as pain and redness. Following that I had no symptoms. On Friday, (1/15) I noticed that the left-side lymph node in neck/collar bone area was swollen. The area felt similarly to that of a cyst. Starting Friday night, I began taking amoxicillin to prevent a bacterial infection. The swelling/cyst like bump on my neck/collarbone has decreased in size, but the vaccination sight has become very red, swollen, and itchy at times.
Shingles; spots on my arm lower than the injection site; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd July 2019, the patient received the 1st dose of Shingrix. On 6th July 2019, 4 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional information received were as follows: In the evening, the patient received Shingrix shot. The patient experienced few spots on arm lower than the injection site and those spots have now developed into shingles. The patient would like to know was how common is this for the Shingrix shot to bring shingles. The patient did not understood that to be possible, but she had proof that it was.
virtually no reaction to the second(except when I touched the site of injection I felt a little sore arm.; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 13Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) in response to consumer letter sent via follow-up letter. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EM9810; expiration date: 30Jun2021) dose 2, via intramuscular, administered in arm left on 19Feb2021 09:00 (age at vaccination 69-year-old) as single dose for covid-19 immunisation. Medical history included, ongoing hypertension, family history included hypertension and heart disease, gall bladder removal on an unknown date Jun2015, cataract surgery on an unknown date 2016. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EL9262; expiration date: 31May2021), via intramuscular, administered in arm left on 28Jan2021 16:30 as single for COVID-19 immunisation and experienced sore arm. Concomitant medication included lisinopril taken for hypertension (taken for years). The patient experienced virtually no reaction to the second (except when i touched the site of injection i felt a little sore arm on an unspecified date. The patient reported that called to Pfizer to get info about people who experienced no reactions. and if this made them more suddenly to get COVID. Patient reported that had no adverse reaction. Patient contacted Pfizer to find out if booster shots were planned as of that date none had been planned although the current variant didn't exist. Patient was concern with her lack of any reaction and that Patient would be less covered by the vaccine than those experienced AE's. Patient still remain concerned as to how effective your vaccine will be in protecting against the variants, unsure if body made any antibodies. Asked doctor if patient could get a fiter test just for peace of mind. Knowing that, the doctor said was not being advised at this time. Patient was concerned about breakthrough vaccines and wish he could receive a booster. Since patient was totally vaccinated almost five months ago patient worry that he will be less protected when increased cases hit the area this fall. Patient did know that people can still be protected even if they didn't exhibit an outward reaction. But without knowing patient had antibodies, patient did not feel comfortable removing her mask indoors or with large groups. Please make a booster and offer it to those like me who remain uncertain as to our immunity. No treatment medication was received for the adverse event. The outcome of the events was unknown.  Follow up activities are completed. No further information is expected.
After 10 minutes in observation (2:10), patient felt dizzy, sweating, hot, fuzzy eyesight, nauseous, ears ringing; BP 88/68, pulse 65, O2 99%. 2:20 tingling throughout body, BP 105/62, P81, O2 99%. EMS arrived 2:30 BP128/82, P76, O2 100%. Symptoms resolved 2:39 and patient left with roommat
Changes to menstrual cycle- it lasts 1.5 weeks longer and there is heavier bleeding
swelling of upper legs 45min p/vax;regression w/in 24hr p/treatment w/solumedrol & DPH;
Patient felt faint on the way home. Passed out briefly about 1/2 hour after vaccination. Over the next 24 hours: nausea, vomiting, loss of appetite, diarrhea, clammy skin, cold sweats. Subsided after 1 and 1/2 days, with remaining malaise and tiredness.
This spontaneous report as received from a clinical medical assistant refers to a female patient of unknown age. The patient received their second dose of GARDASIL (lot number unspecified) in June 2008 and was in the office today, on 08-APR-2013, to receive their third dose of GARDASIL (lot number unspecified). The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
After first dose, extreme fatigue, joint pain, brain fog and difficulty performing duties. After second dose, ultimately hospitalized, found to have severe inflammatory spondyloarthritis, aortitis, coronary vasospasm, and hyperadrenergic dysautonomia with refractory HTN. Prior to this, losartan had been weaned and was almost to the point of stopping it. Later, developed cerebral involvement. Had episode of asystole. Developed eye involvement necessitating neuro-ophth eval. Ultimately, placed on multiple immunosuppressives and called "psoriatic arthritis" because no one would cover meds related to reactive arthritis from vaccine. Multiple hospitalizations after that, monthly, due to complications from the vaccine complication and/or meds necessitated by the vaccine reaction.  Most recent being 9/9-9/12/2021.
fever,headache,bodyache.  c/o subjective fever, chills, and body aches after receiving 2nd dose of Moderna COVID vaccine yesterday around 0830.  Pt took 2 tabs of tylenol with some improvement of sypmtoms.  Pt concerned for ability to perform duties at work.HPI: 26yo M presenting to ED for above complaints after receiving the second MODERNA COVID vaccine yesterday. He has no focal neuro deficits, no dyspnea or chest pain, or any other complaints.
DRUG ADMINISTRATION ERROR; This spontaneous report received from a patient concerned a female of unspecified age. 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. No concomitant medications were reported.  On an unspecified date, the subject experienced drug administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administration error was not reported. This report was non-serious.
103.5 temp for first 4 days. Coughing and chest congestion. Blood with coughing. Urgent Care administered XRay, and listened to lungs, was told unusual sounds coming from bottom of left lung. Temp stayed 102-102.5 even after taking 600 mg ibuprofen for every 6 hours. It has been almost 2 weeks, temp is now 99.4-100.
2 little brown spots; red rash on top of the swollen part under the left eye; a swelling started on her right side of her face; her whole head felt hot; she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot), SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye), RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye) and RASH MACULAR (2 little brown spots) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 041C20A) for COVID-19 vaccination.     Concomitant products included CALCIUM, VITAMIN D3, CELECOXIB, LISINOPRIL and SIMVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye). On 26-Mar-2021, the patient experienced SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot) and RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye). On an unknown date, the patient experienced RASH MACULAR (2 little brown spots). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red rash, Facial swelling and Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (a swelling started on her right side of her face), FEELING HOT (her whole head felt hot), RASH ERYTHEMATOUS (red rash on top of the swollen part under the left eye) and RASH MACULAR (2 little brown spots) had resolved and SWELLING (she had swelling in her neck on both sides/skin, also her gums nose, ears and eyes/swelling under her left eye) had not resolved.            Treatment information include allergy OTC medication.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Except of event swelling all other events outcome updated to resolved. On 29-Jun-2021: No new information.
Pt devel hives and injection site warmth, redness and swelling twenty-four hours post-vaccination.
Pt had immuns 3/17/14 in PM. By evening started having dizziness, body aches, chills, nausea, no appetite. Went to ER that evening (3/17/14). Strep and influenza negative. Pt came in for ER follow up with Dr. on 3/19/14.
hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 23-JAN-2014, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis). On an unspecified date (reported as subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation), the patient was treated by a physician for hearing loss. As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, hearing loss was determined to be medically significant.
COVID vaccine breakthrough case. Moderna 016J21-2A 1/31/2022, 066K21A 3/17/22, and boosted 6/17/22 005M21A
First I felt so cold, fever and I was shaking alot, body pain and pain in my ears, eyes, forehead and in my throat. I have one day with this sintoms by now.
This spontaneous report has been received from a Medical Assistant, concerning a female patient (reported as around twenty years of age). The patient's medical history, concurrent conditions and concomitant medication were not provided. On an unknown date in her childhood, the patient was vaccinated with VARIVAX; (dose, route of administration, lot and expiration date were not provided) for prophylaxis. Other suspect therapies included M-M-R II  (dose, route of administration, lot and expiration date were not provided) for prophylaxis; both vaccines were reconstituted usiag a sterile diluent (MANUFACTURER UNKNOWN). The reporter stated that on unknown date, the patient had lab studies for infertility treatment, that showed negative titers for MMR and Varicella (antibody test negative). The outcome of negative titers for MMR and Varicella, and infertility were unknown. The causal relationship between the events and the suspect therapies was unknown. Product quality control was not involved. Additional information has been requested.
Patient received injection at 17:30 her head started itching at 19:00 her hands, wrists were itching at 21:00.  She noted blotches and itching on her trunk, hips and legs and upper lip was swollen.  She visited her physician on 10/30 and received Allegra for the symptoms.  This alleveated her symptoms.
I started to experience paresthesia in my hands the day after receiving the 3rd dose/booster dose. I also experienced very vivid dreams and was unable to wake easily. The paresthesia lasted about 5 days.
@ 13:50 Patient reported Dizziness and rapid heart rate, I called code assist, and took pt vital signs her readings were, BP: 147/89 o2:100%, PR: 114, code assist arrived and took patient into the clinic for further assistance.
NAUSEA, VOMITTING AFTER 15 MINUTES OF ADMINITRATION OF VACCINE
On Saturday May 22nd 2021, I was 5 weeks and 5 days pregnant. I had my second Pfizer vaccination at around 9am. Approximately four hours later, I experienced problems trying to empty my bladder. Severe abdominal pain developed. We went to urgent care, they sent me to the nearest ER. I was advised to stay overnight. The pain persisted. The following morning, urine was drained from my bladder with a urinary catheter. We were told it was near to 2 liters in volume. It was deemed a case of urinary retention. I had to continue wearing a catheter on leaving hospital. A urologist later suggested self-catheterization. I tried it. It was painful and distressing. I opted for an indwelling catheter to go back in. I wore a catheter until June 29, 2021. That's more than five weeks after the day of occurrence.    No previous pregnancy. Due date: Jan 17, 2022.
The adverse event began with itchy lips and a red mark by his mouth. He began coughing a lot and the red rash spread around his mouth, nose, forehead, and ears and was accompanied by a severe itching. He began coughing a lot and complaining of stomach pains and a weird feeling in his mouth. The rash continued to spread throughout his entire body. He had a bout of diarrhea. Took him to the after hours medi-center and they gave him Benadryl and monitored his progress. The Benadryl relieved some of the itching and redness.
straight screaming for 2-3 hrs non stop; fever 101; leg swollen, red & hot;
1 Day post, patient experienced erythema, edema and tenderness with axillary lymphadenopathy to left post. upper extremity.
Puffy arms; Jittering in chest; Warm and pink Cheeks; Pain in arms; arms itching inside of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm). At the time of the report, PERIPHERAL SWELLING (Puffy arms), FEELING JITTERY (Jittering in chest), FEELING HOT (Warm and pink Cheeks), PAIN IN EXTREMITY (Pain in arms) and PRURITUS (arms itching inside of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she is taking concomitant medication (unspecified) and will follow up with her healthcare professional.
pt recv vax 15NOV96 & 17NOV96 returned to office w/rt deltoid inj site w/redness, swelling & induration of lower 1/2 arm per MD assessment @ approx 49 hr p/inj;dx local rxn to DTP r/o early cellulitis;