chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 2 month old female with no pertinent medical history and no known drug reactions/allergies who about two weeks ago (10-SEP-2007) was vaccinated with first 2 ml oral dose of Rotateq. Concomitant therapy included Pediarix, PedvaxHIB and Prevnar. Subsequently within a few days of vaccination, the patient experienced diarrhea for about 10 days with blood in stool. Her stools were tested in the office and were positive for occult blood. A stool specimen was collected for the lab for blood and results are pending. The blood in stool resolved after a few days but the patient's diarrhea persisted. The patient was seen in the physician's office. The patient required no treatment and continued with routine feedings. Upon internal review blood in the stool was considered to be an other important medical event. There was no product quality complaint involved. Additional information has been requested.
Case number PHEH2012US023202 is an initial spontaneous report received from a nurse on 20 Nov 2012. This case refers to a 29-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 123324) on 10 Oct 2012. On the same day of vaccination she experienced pain in the arm and swollen area at the injection site that was full of pus. Saw her physician on 17 Oct 2012 due to these events. On 25 Oct 2012 she returned back to see her physician and all the symptoms had dissipated. The seriousness and causality was not reported.
. Pfizer dose 1 on 3/30. Just had sore arm. Symptoms dizziness began on 4/3. Otherwise feeling well. Labs drawn 4/5 which revealed pancytopenia, rechecked today and numbers are worsening. Working to get him into hematology now. 28 yo male s/p Covid-19 Vaccine (Pfizer) on 3/30 with lightheadedness only when bending down and coming up returns for follow up today for pancytopenia found on labs obtained 4/5. He denies any recent viral symptoms. He did not have any episodes in past that made him question that he may have had Covid-19 viral illness. He is able to tolerate his normal daily exercise and bike without any symptoms. He has no dietary restrictions, eats dairy, meat, lots of vegetables/fruits, pastas and some breads/cereals. He drinks alcohol once per week. He abstains from ETOH every April. He has used edible THC in past, only once per month at most. He has not been tested for HIV in past. His girlfriend, in last semester of school advised him to ask about HIV testing. He denies any chest pain, SOB, HA.   Upon review of his lab results yesterday, I called the hematology fellow, Dr. through program at hospital and he recommended the labs to be obtained and rechecking labs in one week. He felt the student was not exhibiting any emergent symptoms requiring emergent evaluation. Patient and I spoke on phone after this call with fell at 1557 4/6 and I advised him to seek emergent medical eval in ED for any CP, SOB, HA or any neurologic symptoms. Patient has not had any of those symptoms. He exercised this morning without difficulty.   He notes raised papules on legs which he has had in past. They have currently been present for a few days. He believes it to be related to biking in sweatpants. He has been in a hot tub recently, but after the bumps were present. They do not itch. He has had them in past, more in winter months with heavier clothing.    He also notices slight left arm pain today. This was site of his vaccine. He denies any swollen lymph nodes. He is notices only with arm movement.   He denies any FH of blood disorder/ blood cancers/MDS. He denies bruising, bleeding or dark stools.   He states he likely has not had a blood draw in past, unless one visit to ER, for HA/concussion in high school (9+yrs ago) resulted in any blood test.
Shot was injected high on left arm towards the back of arm. It bled quite a bit and the pharmacist took awhile to stop it. (compared to any other shot I ever received. The arm has not stopped hurting since. When I raise my arm over my head or ben elbows and pull arms back it hurts. It feels like it is locking up and I'm restricting my movement to avoid the pain. Looked up info and I've seen it could be it hit a nerve?
Arm soreness; Dizziness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizziness), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was provided.  No treatment details were provided.
This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 94-year-old female patient who received SHINGRIX (batch number B9739, expiry date 30th November 2018) for prophylaxis. Concomitant products included Aspirin, Calcium, estradiol and fish oil. On 7th June 2018, the patient received the 1st dose of SHINGRIX. On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced diarrhea, pain in arm, general body pain, influenza-like symptoms, skin warm and tiredness. On 8th June 2018, the patient experienced welts. In June 2018, the patient experienced feeling unwell. On an unknown date, the outcome of the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm, tiredness and feeling unwell were recovered/resolved. The reporter considered the diarrhea, pain in arm, general body pain, influenza-like symptoms, welts, skin warm and tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. This case was reported by the patient's daughter. The patient took CENTRUM SILVER as an concomitant medication. The patient received the SHINGRIX vaccine at around 10:30 AM. The patient experienced sore arm, diarrhea, she did not feel good and she had a one inch welt on her arm which was warm to the touch.
Lt shoulder pain moves across chest , multiple joint pain, sensation he was dying, blood sugars 275-280
After 10 days of my first pfizer covid-19 vaccine shot, I have rash on my face and started to spread to my eye, neck, finger, and hands; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 02Apr2021 at 11:15 (at the age of 42-year-old) as a single dose for COVID-19 immunization. The patient had no medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 12Apr2021 at 16:00, after ten days of the first vaccine shot, the patient experienced rash on face which started to spread to eye, neck, finger and hands. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events rash on face which started to spread to eye, neck, finger and hands was not recovered at the time of this reported.  No follow-up attempts are needed. No further information is expected.
24 hours after vaccine - fever, chills, and aches.  Currently (4/21/21) having chest pains.  Doctor appointment this afternoon.  He suggested I fill out the adverse reaction page.
Parents reported intermittent fever since 05/16/2016. Mother took temporal temperature around 05:30pm and it was 101.9. Medicated with TYLENOL. Patient then had a seizure while laying on the couch with her mother. No prior history of seizures. Mother states patient began convulsing, eyes rolled back in her head, patient began drooling, and was incontinent. Episode lasted less than 1 minute, postictal for several minutes afterwards. Parents called 911 and child was transported to nearest ED via ambulance. Medics reported her temperature during transport as 104. Upon arrival to ED child was medicated with MOTRIN and then fell asleep for a 30 minute nap. Parents noted to ED provider upon waking child was fussy and appeared to not feel well, but otherwise acting like her normal self. Patient discharged from ED at 9:25 pm. Instructed to follow up with primary pediatrician.
fast heartbeat, dizziness and weakness; patient presented to the ED on 2/26 with pelvic pain and cramping for possible miscarriage or ectopic pregnancy. Pt was at approximately 5 weeks gestation
Flu-like symptoms, stabbing chest pain, dizziness, fatigue, rash, and wheezing that developed around 0930 on 3/9.
Pain at injection site and entire shoulder, approx. 12 hrs. after injection I developed chills and a fever of 100.6.
This spontaneous report as received from a pharmacist refers to a 67 years old male patient. On 19-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#not reported) that had been improperly stored at 50F for at least 24 hours. No other co-suspects were reported. The patient did not sought medical attention. No adverse event observed or reported. Additional information has been requested.
Hospitalization for COVID symptoms on dates 7/1/22-7/2/22.  Passed away on 7/2/2022 with DNR. Treated with no COVID-related medications.  Primarily treated for infection.
woke up in the middle of the night on 12/02/2021 after his second dose of the COVID-19 Vaccine with a 102.1 degree fever, chills, body aches, cold sweat, and nausea. This continued off and on through the date of 12/02/2021. I treated him with ibuprofen every 4 hours, as well as 1 Zofran tablet for the nausea in the morning that we had leftover from a previous illness that he had in March of this year. The chills and body aches remained when he woke up the morning of 12/03/2021 with a 99.9 degree fever that morning, which is not terribly high but is not normal for him. I again treated with ibuprofen as needed on 12/03/2021. He was feeling back to himself with no additional issues on 12/04/2021.
Pt recv vax on 7/20/98; 2 hr post vax pt exp shortness of breath, fever (101F), chills, pallor, dizzy, pink color of vax arm; dx=allergy to tetanus vax; tx=Benadryl, fluids, Tylenol, rest
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
A vein had been hit, patient had a little bruise; It is extremely itchy; Rash 2 inches below injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis and Asthma. Concomitant products included NAPROXEN (MOTRIN [NAPROXEN]), OXYCODONE, METFORMIN, VENLAFAXINE, LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CONTUSION (A vein had been hit, patient had a little bruise), VACCINATION SITE PRURITUS (It is extremely itchy), VACCINATION SITE RASH (Rash 2 inches below injection site) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A patient received 3  different types of  COVID- Vaccine injections. Patient received Moderna Vaccine 02/17/2021 @  Health Center,  received Janssen on 05/08/2021 @ Emergency Center, and received Pfizer on 08/13/2021.  No Adverse reactions noted.  Patient called to schedule appointment with a physician at family health center, Patient has not responded to phone call.
She is currentlyapplying for disability due to health conditions that limit her.; she has had a Pneumovax 23 vaccination, but not Prevnar 13.; she is not eligible for the Prevnar 13 at her age with her current diagnoses; she is not eligible for the Prevnar 13 at her age with her current diagnoses; This spontaneous report was received from a physician, via Pfizer, regarding a female patient of unknown age. The patient's concurrent conditions included severe asthma and bronchial hyperreactivity. The patient's medical history included very frequent and prolonged hospitalizations for respiratory issues (respiratory disorder) and respiratory distress. Concomitant medications were not provided.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (lot # CW5295, expiration date was not provided) for prophylaxis.  On an unspecified date, at a recent office visit, it was found that she had had a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccination, but not pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) (Wrong product administered). Given her health situation with very frequent, prolonged hospitalizations for respiratory issues and distress, she needed both vaccinations to complete her protection. It was reported that she was not eligible for pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) at her age with her current diagnoses, however, knowing the severity of her asthma which had required multiple hospitalizations, the reporter considered she definitely needed it for her maximal protection (Product administered to patient of inappropriate age and Circumstance or information capable of leading to medication error). She was currently applying for disability due to health conditions (Ill-defined disorder) that limited her.  The outcome of Ill-defined disorder was unknown.   The causality assessment between Ill-defined disorder and therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was not provided.  The event Ill-defined disorder was considered to be a disabling event.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored ROTATEQ lot # M019690 and expiration date: 02-NOV-2017; via oral route (dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Mother called 01/05/2012 to report that client has had a sore arm since vaccinations in Nov 2011.  Has not seen a doctor or called previously to notify health department.  When asked for more information mom would state that her arm hurts.  Instructed to call physician to be seen.  Mom reports no insurance that is why they were calling the heatlh department.
nausea, emesis, syncope, as well as extended tiredness, headache, joint pain, fever
Patient experienced hives to left arm migrating to left side of neck.  Also had cough.
Patient described erythema and itchiness to right upper arm where vaccine had been given starting the evening of 1/18/2021. Was seen  and given creams to place on her arm. When I saw her the AM of 1/19/2021 the arm was normal. She is a nurse and was concerned enough to seek treatment.
Baby died 4 days after vaccines were given, death is under investigation cause of death is still unknown 6/15/09 Autopsy report also states patient had fever since receiving vaccinations.  6/15/09 Autopsy report states COD as unknown./Had been given Tylenol & put down for nap.  Found face down between pillow & mesh of playpen.  Attempted resuscitation but patient with rigor & unsuccessful.  Noted to have dried blood around nose.  Skeletal survey, drug & metabolic testing all WNL./
Fatigue, fever, muscle pain, tinnitus, dizziness, sore throat, headache
Symptoms about 16 hours after injection: extreme lethargy, achiness if both arms and neck, swollen lymph nodes on opposite side of my neck (left side while vaccine given in right arm), small red nodule at injection site (raised, warm, non-pustule). Symptoms 36 hours after injection: extreme lethargy, achiness in vaccination arm only, swollen lymph nodes on opposite side of my neck though less marked (left), nausea, moderate red nodule at injection site (raised, warm, non-pustule). I have never had these symptoms before.
Pt received second dose in series 4 days early. No adverse effects occurred as a  result of early administration.
loss of feeling in legs as well as incoherent behavior; loss of feeling in legs as well as incoherent behavior; Upon a CT scan an aneurysm was discovered that was actively bleedings.; extreme headache/severe headaches; went to ER via ambulance in 31Jan2021 for extreme headache and body lameness; This is a spontaneous report from a contactable Consumer. A 44-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medication included allergy pills. Patient went to emergency room (ER) via ambulance on 31Jan2021 for extreme headache and body lameness, which started on 31Jan2021 22:00. Patient was discharged from ER on 01Feb2021. Patient returned to ER via ambulance on 09Feb2021 due to severe headaches and loss of feeling in legs as well as incoherent behavior. Upon a Computerised tomogram (CT) scan an aneurysm was discovered that was actively bleedings. Patient was transferred to medical center and is currently waiting surgical procedure. Adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Patient came to ED with increasing shortness of breath, cough, and diarrhea.  Patient is admitted with Covid and treated with remdesivir.
Patient came for vaccination in the morning, then went out to breakfast. During breakfast, the patient slumped forward in his seat and was unresponsive for about a minute. There was no incontinence or seizure activity. On regaining consciousness, patient seemed to quickly get back to his usual level of mentation. He was diaphoretic and nauseous. He denies any preceding lightheadedness, nausea, visual changes, chest pain or palpitations. He presented to the emergency room, also had nosebleed and UTI. Was admitted for observation overnight and discharged the next day.
Diarrhea. A father reported that his son now 3 yrs old,may have received an injection of RotaShield. The child has experienced chronic diarrhea off and on since 7/2000. No further information was available at the date of this report.
approx 1yr p/vax pt exp vesicular papule lesions highly characteristic of chickenpox.  Follow up on 06/28/00 states: "It is unknown if the vaccine recipient has recovered from its adverse reactions."