chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant via company representative and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced the "worst case of shingles the facility has ever seen". The patient thought that the rash that developed was caused by yard work he was doing (on an unspecified date) and treated himself with a heating pad. On an unknown date, when the patient fell asleep with the heating pad the blisters worsened. A week after the symptoms initiated, the patient went to see his physician who referred him to see a specialist. Within the last ten days, the unspecified specialist confirmed the patient had a case of shingles and treated him with an unspecified antiviral medication. The patient was also offered unspecified pain medication but he refused to use it due to having no pain. The outcome of shingles was unknown. The relatedness between the shingles and ZOSTAVAX was not reported. Additional information is not expected as there was no consent to contact the physician.
3 hours post vaccinations, my daughter began vomiting. The follow 36 hours, the vomiting became more frequent in that she was no longer maintaining any feeds. At hour 48, I took my daughter to the ER afraid of dehydration. We were then admitted and kept at hospital for 3 days and transferred to another hospital for a following 4 days. During those 7 days in the hospital my daughter did not keep any feedings down and lost 2 lbs.  All tests ran by doctors found no abnormalities of her anatomy to have caused this persistent vomiting. We were discharged from the hospital in the seventh day after my daughter maintained 2 feedings and gained a minimal amount of weight. The days following hospital dishacrge, my daughter was able to eat more and more ounces during feedings and is now playing catch up for weight gain.
Dry mouth, teeth loss, extremely fatigued, hemangiomas, rash, loss of hair, metallic taste
One day post vax, the vaccinee experienced a round, slightly raised, red, indurated area below the injection site with red margins.
Initial information received from a healthcare professional on 17 April 2013. A 68-years-old female patient, had received a dose of ADACEL vaccine (Lot no: U4586AA, route and site of administration were not reported) on 15 April 2013. Patient had no medical history and her concomitant medications were not reported. She had allergies to PCN (Penicillin) and Sulfa (Sulfonamide). Patient had received tetanus containing vaccine 5 years ago. On 17 April 2013, the patient had experienced swollen, hard, red, warm to touch area around injection site which had "streaks" or red lines extending from down arm. Corrective treatments and complementary investigations were not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
she could barely walk/couldn't walk hardly; feeling cruddy/doesn't feel good at all; She slept from the time she got home, all night. and part of day today; this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose; running a fever; Fatigue/she is tired again; very weak; nauseated; Headache; Her throat didn't feel right; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at half dose, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications.  It was reported that the patient previously received INFLUENZA VACCINE for immunization but she gets nauseated and tired. On 29Dec2020, she was very weak, nauseated, had a headache, fatigue and her throat didn't feel right. On 30Dec2020, she was running a fever, it was 100.5 (units unspecified). It was also reported that she could barely walk; further reported as couldn't walk hardly, she was still feeling "cruddy" and she just doesn't feel good at all. The patient reportedly slept from the time she got home, all night and part of day today. After she rests for a while, once she gets up, she is tired again. It was also reported that the patient was told that this was the first dose which is a half dose that they had to split the one dose into two because it was too powerful for one dose. She will receive her second dose on 19Jan2021. Outcome of the events "very weak" and "fatigue/she is tired again" was recovering; outcome of events "nauseated", "headache", "her throat didn't feel right" and "running a fever" was not recovered; outcome of the events "could barely walk/couldn't walk hardly", "feeling cruddy/doesn't feel good at all" and "slept from the time she got home, all night and part of day today" was unknown.  Information about lot/batch number has been requested.
After receiving a 1st dose of Pfizer vaccine, patient fell to the ground within a minute. A pharmacist rushed back to check her heart rate and consciousness. She was quickly alert and breathing normal. She did not recall what happened. Her face was still pale and she felt dizzy. 911 was called. After 5 minutes, she had new seizure episode last for 10 seconds then stopped. 911 came and checked her blood pressure, heart rate and oxygen level. They were all normal. Patient was advised to see doctor for follow up. Her mother took her to seek medical care.
patient received double dosage of vaccine one week apart with no A/E; Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via a consumer via phone call (under Global Medical Information (GMI) Inquiry Number: 00845641).  This case involves a 6 months old female patient who received double dosage of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] one week apart with no adverse event (extra dose administered).  The patient's medical history, past medical treatments, vaccinations, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL). PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  On 13-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 20-Oct-2021 she also received a second dose of the same vaccine (lot UT7376LA and expiry date: 30-JUN-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to extra dose administered (latency: same day).  It was reported "Health care professional (HCP) asks if the child still needs to be given another dose of FLUZONE QUADRIVALENT in 4 weeks?"  At the time of reporting, no adverse event was 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 by the regulatory authority. 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.
pt states noted swelling & bruising on arm on 25OCT97;called CHD & told to come in 26OCT97 lt arm from shoulder to elbow red, swollen & hot to touch;some red streaking noted;bruised area noted just below inj site & extending to inner arm;
a non-raised red rash appeared on chest and stomach area...also partially on my back; As the rash faded, I have an itch everywhere the rash existed; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) at the age of 73-years-old, via an unspecified route of administration in right arm on 15Feb2021 at 12:15 at 1st dose, single for COVID-19 immunization. Medical history included being asthmatic. She has no other chronic health conditions, no known allergies, and has no COVID prior to vaccination. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) and acetylsalicylic acid (ASPIRIN). There were no other vaccines in four weeks. The facility where the vaccine was administered was reported as other. On Feb2021 (also reported as 11Feb2021 at 08:30), a non-raised red rash appeared on her chest and stomach area and also partially on her back; as the rash faded, she had an itch everywhere the rash existed. No treatment was given in response to the events. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
See attached page. On 09/19/2012 patient received inactivated INFLUENZA vaccine and developed a hard lump at the injection site immediately after vaccination into left deltoid. Patient was instructed to sit and wait for 15-20 minutes for observation and to make sure no further reaction developed. Upon walking to waiting area, patient became light-headed and wanted to lie down. As she was being helped to bench where she could lay down, patient fainted. We laid her down on the floor and elevated her legs. Patient was given ammonia salts and blood pressure was taken (116/83, pulse 64). Patient was alert and responsive throughout this whole time. Patient was then given water and stated that she was feeling better and wanted to attempt to sit up. Upon sitting, patient stated she began to feel light-headed again. Her blood pressure was taken at this time and it was 93/65, pulse 66. Patient was instructed to lie down again and legs were elevated. A co-worker grabbed a bag of Fritos to give to patient to try to bring her blood pressure (something salty). Patient continued to eat and drink while lying down and blood pressure was taken again (118/84, pulse 65). Patient then wanted to try to sit up again. After a few minutes of sitting, blood pressure was taken and it was 84/57, pule 66. At this time, patient reported seeing spots in her vision. She related this to how she felt she felt sometimes when she had atypical migraines (aura). Patient's blood pressure was again taken while sitting and it was 95/74, pulse 67, so she was laid back down again. When it became apparent that patient's blood pressure was not holding upon sitting EMS was called. By the time they arrived approximately 45 minutes had elapsed since the injection and approximately 30 minutes since patient had fainted. EMS spoke to the patient, took her blood pressure, and found it holding around 100/75. Patient reported feeling much better and no longer seeing spots. She was released into her husband's care and went home. We attempted to reach the patient to check on her status in the afternoon on 09/19 without success. A second attempt to reach the patient was made on 09/21 and was successful. Patient reports feeling much better with no residual or returning symptoms. The patient called her doctor and informed him of the episode but has not received any additional instructions. She reports being thankful that we were attentive and helpful during the episode and the she ultimately is feeling better and did not require hospitalize. Her only concern was whether or not she will need revaccination. We informed the patient that this episode should not affect her immune response to the vaccine.
Arm soreness after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010U20A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for COVID-19 vaccination.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose) had resolved.            No treatment information reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Lymph node swollen under left arm (injection arm) starting on day 5 after vaccine and lasting at least a week
Patient received her 2nd dose in the series on 3/3/21 at 21 days from 1st dose.  COVID vaccination clinic was held at the same facility on 3/9/21 and patient inadvertently was administered an additional dose. No signs or symptoms at time of administration. Notified and have been monitoring for additional ADEs. Contacted yesterday in a follow-up call and states the patient has had no additional issues since the dosing administration error.
Pt vaccinated with MMR/Haemophilus B 2 months later developed bruising w/a subsequent dx of severe aplastic anemia; Pt hospitallized. Liver enzymes were noted be be elevated. Reporter felt aplastic anemia possibly due to MMR vax.
A lot of cases were patients received the 2nd dose late; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.  HCP stated that they were seeing a lot of cases were patients received the 2nd dose late and wanted to know if they had to report all of them.   This case was linked to MOD-2021-225625, MOD-2021-246765 (E2B Linked Report).; Sender's Comments:  MOD-2021-225625:Same reporter MOD-2021-246765:Same reporter
The patient presented in the office on November 16, 2007 with vomiting, cramping abdominal pain.  She had not had a bowel movement for 2 days.  Her abd./gastro was soft and hypoactive.  She was diagnosed with viral gastroenteritis.   Pt. mom was told to supplement with Pedialyte 1/2 ounce every 15-20 minutes until the patient had not vomited for 6 hours.  She was told no solids for 24 hours and to give Mylicon drops every 4 hours as needed.  She was also told to go to the ER if it worsened over the weekend.  The patient then presented to the Emergency Room 11/18/2007 at 4:15 a.m. with worsening symptoms.  The ER did a KUB that showed nonspecific bowel gas pattern the ER physcian then consulted a General Surgeon who ordered an abdominal ultrasound.  The abdominal ultrasound was postive for intussusception localized in the right upper quadrant mainly pointing at an ileoceal or ileo-ascending colon intussusception.  The patient then underwent a hydrostatic barium enema reduction of her intussusception that failed.  So the patient was then transported to another facility where the intussuception was reduced.  2/7/08 vax rec received; no update needed- vax/lot # are as reported. 2/8/08 Reviewed ER medical records which reveal patient experienced abdominal pain & bilious vomiting x 3 days.  Transferred to higher level of care for peds surgical consult. 2/19/08 Reviewed hospital medical records which reveal patient experienced IS unable to reduce via BE at outlying hospital.  Had bilious emesis & abdominal pain 3 days prior to admit,  seen by pcp & dx w/recurrence of viral infection.  Resolved & recurred again & crying inconsolably.  Admitted 11/18-11/19/2007.  Surgical consult done.   FINAL DX: Intussusception, enema reduced.
pt vaccinated with 2nd covid vaccine on feb 18, 2021 and 2 weeks later developed sudden chorea like movements which progressed to where his wife thought he might be having a seizure and he was brought in and hospitalized on 3/13/2021.  Pt admitted with acute choreaform movement pattern, possible encephalopathy(having acute mental status changes) and acute functional decline. Pt prior was independent with ADL's, had smooth speech pattern and walked independently with a walker. there have been no recent medication changes or illnesses.
Tremors,  head and torso shake uncontrollably for 10-60 seconds,  at least one per week, no treatment yet. Extended sleep disruption, prior to shots, slept at least one 5-7 hour stretch, beginning 2/26/07 no more than 3 hour stretch, no treatment yet. Hives / welts, screaming, 1-1/2 hours, one dose of children's Claritin. Fever, temperature 100 degrees, screaming, 1-1/2 hours, on e dose of children's Tylenol.
she fell on the floor and become unconscious; she fell on the floor and become unconscious; She got sick; she lost all energy; She hurt her throat its like she can read but she has very heavy under her neck; She hurt her throat its like she can read but she has very heavy under her neck; This is a spontaneous report from a contactable consumer (Father). An 18-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on 28May2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient Medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. It was reported that, On 28May2021 caller stated that we took our daughter to get vaccinated on 28th and she loss of conscious and she got sick, and it took almost 24 hours to recover so we need to get the forms, so she does not get her second shot and we do not want to have a second shot for her because of the lot reaction on her body. In the 22nd day later she fell on the floor and become unconscious, and she lost energy and you know it takes time to come up and it take 2-3 minute to come up and she lost all energy and she hurt her throat it's like she can read but she has very heavy under her neck. The event loss of consciousness, fall and illness was recovered on unspecified date in 2021.The event musculoskeletal discomfort oropharyngeal pain and asthenia was unknown.  Therapeutic measures were taken Tylenol and green juice as a result of she fell on the floor and become unconscious (loss of consciousness), she fell on the floor and become unconscious, she got sick, she lost all energy, she hurt her throat it's like she can read but she has very heavy under her neck, she hurt her throat it's like she can read but she has very heavy under her neck (oropharyngeal pain).  No follow-up attempts are possible. No further information is expected.
Patient reported to me on 12/23/2016 that she has had cellulitis for over a month and continues to experience symptoms such as itching despite prednisone and diphenhydramine. Patient states she has had 2 visits to the ER because she has been so ill.
Patient reported fatigue, with joint and nerve pain throughout body.  symptoms started within 24 hours of administration and lasted about 48 hours.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (lot #, dose and route of administration were not reported). The patient received the second dose of GARDASIL 9 (lot #, dose and route of administration were not reported) two months after receiving the first dose (on an unspecified date). Subsequently, on an unknown date (four months after receiving the first dose), the patient received the third dose of GARDASIL 9 (lot #, dose and route of administration were not reported). No symptoms were reported. Additional information has been requested.
Hoarse voice; Laryngitis; This is a spontaneous report from a contactable healthcare professional, the patient. A 40-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Sep2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 04Sep2021 at 12:00, the patient experienced hoarse voice and laryngitis. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarse voice and laryngitis were not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Severe itching  and  angry red hives approximately 2.5 inches by 5 inches.  No controlled by hydrocortisone.  Hot to touch.