chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From initial information received on 13Apr04 from a pt regarding an adverse event occurring, it was reported that a 27 year old female pt received an Imovax rabies vaccination series, lot number, route and site of admin unk starting on 11Feb04. The pt received doses one through five on 11Feb04, 18Feb04, 18Mar04, 09Apr04 and 14Apr04, respectively. On 29Mar04, 11 days after third dose, the pt developed muscle soreness in her neck, back, shoulders and arm, difficulty sleeping, and a rash on her arm and leg with itching that lasted 48 hrs. The pt is still having muscle soreness, difficulty sleeping and lightheadedness. It is unk whether the pt fully recovered. From additional information received from a health care professional, it was reported that the pt had received her first dose of Tetanus toxoid admin IM in the left buttock on 09Apr04. She received a fourth dose of Imovax Rabies, lot number X05812, admin IM in the right arm on 09Apr04 and a fifth dose Imovax rabies, lot number X05812 administered IM in the right arm on 14Apr04. The responsible physician name and address was provided as well as the complete address of the pt. It is unk whether the pt fully recovered. No further information is anticipated, this case is considered closed.
Patient is only 15 years old, but was given a Booster shot (3rd shot)on 12/29/21.  First shot given 3/22/21 second shot given 4/19/21
Pt received Adacel approx. 9:30am At about 7pm she began having diffuse joint pain and tool 1000mg of Tylenol. Following morning she awoke with intense diffuse joint pain and a rash over arms and legs. She had a similar rash before resulting from Ultracet. She discontinued the Tylenol and started Ibuprofen for the joint aches and Benadryl for the rash. The following am the rash had resolved, but the joint aches continued.  She continued with Advil. The next am she saw Provider for joint aches and a lymph node that had become tender. She was instucted to continue with Ibuprofen for the next 3days and was administered a Kenalog injection.
Information has been received from a consumer who on 14-NOV-2008 was vaccinated with a dose of ZOSTER (Oka/Merck).  She reported that "3 days ago", on 14-NOV-2008, her 52-year-old son who lives with her started to experience fever, chills and soreness on the right side of his head and he was in bed for 3 days.  Per mother, when her son went to a physician, he was advised that he had shingles because of his symptoms.  "Visual examination" was performed.  At the time of the report, on 17-NOV-2008, the patient had not recovered from the event.  Additional information has been requested.
Accelerated hearing loss; Accelerated sight loss; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Accelerated hearing loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration, Hearing loss (lifelong hearing loss) and Vision abnormal.  In February 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 DEAFNESS (Accelerated hearing loss) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Accelerated sight loss). At the time of the report, DEAFNESS (Accelerated hearing loss) and VISUAL IMPAIRMENT (Accelerated sight loss) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications were provided.   No treatment medications were provided.  Company Comment - This case concerns a unknown-year-old, female patient with relevant medical history of Hearing loss (lifelong hearing loss). The patient experienced unlisted serious event of Deafness unspecified days after the after first dose of Spikevax. Patient experienced AEs after first dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The reporter did not provide causality.  The patient Concurrent medical conditions of Hearing loss (lifelong hearing loss ) is a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a unknown-year-old, female patient with relevant medical history of Hearing loss (lifelong hearing loss). The patient experienced unlisted serious event of Deafness unspecified days after the after first dose of Spikevax. Patient experienced AEs after first dose and no information about the first dose is available rechallenge is not applicable as no additional dosing will be given. The reporter did not provide causality.  The patient Concurrent medical conditions of Hearing loss (lifelong hearing loss ) is a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
PALE, LOST OF CONSCIOUSNESS X5 SECONDS. CODE GREEN CALLED, DIAPHORETIC, BP 116/80, HR 78, GLUCOSE 83, ALSO C/O DIZZINESS. IV ON LEFT ANTCUBITAL WITH NS, TRANSPORTED TO HOSPITAL.
sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient's relative. The age at vaccination was not reported. On an unspecified date in 2019, the patient received a dose of Shingrix. The patient felt sick (unknown symptoms) that lasted for one week.  No further information was available. The caller wanted to be anonymous and did not want any further contact. The reporter did not consent to follow-up.
pt recv vax; lt arm sore and discolored for 2 wk following inject; by dec 4th, arm back to nl;
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received BEXSERO (batch number 153701, expiry date unknown). On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site pain and injection site bruising. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site pain and injection site bruising to be related to BEXSERO. Additional details provided were as follows: The patient experienced painful or sore arm after vaccination with BEXSERO in the deltoid region of his arm. The patient also had bruising on the inside of the arm in which the vaccine was administered. The reporter stated that she preferred to not answer further questions regarding the event due to time constraints. Further product details and patient identifying information was not available at the time of reporting. No further information was reported regarding the event.
This is a spontaneous report from a contactable pharmacist. A 64-year-old patient of unspecified gender received PREVNAR 13 on an unspecified date in Oct2018, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was very sore and had trouble with range of motion since an unspecified date in Oct2018. Events outcome was unknown. Information on the batch number has been requested.
Pain; Swollen knot; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE PAIN (Pain), INJECTION SITE SWELLING (Swollen knot) and INJECTION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
Patient is a 54-year-old female with past medical history dyslipidemia, hypertension, atrial fibrillation on anticoagulation, intellectual disability who presents with few hours of chest pain shortness of breath as well as occasional heart palpitations.  Patient states that this is occurred for last few hours, had no prodrome of illness. Have was in good health, was taking her all her medications including her metoprolol and Cardizem at home. Admitted 12/09/2021, received booster dose of Moderna on 11/30/2021.
information has been received from a female in a physicians office concerning a 5 year old female who on 1/23/2001 was vaccinated with her first dose of varicella virus vaccine live. Concomitant vaccinations given on that same day included, the first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and third dose of Hib conj vaccine OMPC. On 3/30/2005 the patient presented with herpes zoster and was treated with acyclovir. It was reported that the patient had a good response in 3-5 days with scabbing and resolution. The patient recovered from herpes zoster. Additional information has been requested.
Patient stated the following effects that occurred on 9/10/18 approx. 9 pm: lower back pain (bilateral), body aches, neck ache, anxiety, sleeplessness (the feeling of not being fully asleep throughout the night), moaning during sleep, nightmarish-like state during sleep, some symptoms similar after 1st dose of SHINGRIX, worse with this 2nd dose.
covid test result=Positive, covid test date=12Jan2022; covid test result=Positive, covid test date=12Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: EW0182) at the age of 14 years as dose 2, single and administered in arm left, administration date 21May2021 (Lot number: EW0176) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "covid test result=Positive, covid test date=12Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal swab. Patient had not received any other vaccine in four weeks and had not received Other medications in two weeks. It was reported that reporters 14-year-old daughter had only two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. Had 1 period with only cramps and a small spot of blood on one day in Oct2021. This was very concerning. Spoken with practitioner about their concerns. She had been fairly regular since onset in 2019. It was reported that patient not had covid prior vaccination and was tested to covid post vaccination. It was reported that patient had no known allergies.
General discomfort, nausea and dizziness; General discomfort, nausea and dizziness; Lack of apetite; Tiredness; General discomfort, nausea and dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 30-Mar-2021, the patient experienced DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness). At the time of the report, DISCOMFORT (General discomfort, nausea and dizziness), DIZZINESS (General discomfort, nausea and dizziness), DECREASED APPETITE (Lack of apetite), FATIGUE (Tiredness) and NAUSEA (General discomfort, nausea and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.  on 2 Apr 2021, symptoms diminished except fatigue.
3 days after receiving influenza vaccination, noted total body itching without rash present. 4 days after receiving influenza vaccination sought medical treatment and Zyrtec 10 mg, 1 po daily was prescribed.
Unilateral upper right side lip droop/ weakness; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARESIS (Unilateral upper right side lip droop/ weakness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2022, the patient experienced FACIAL PARESIS (Unilateral upper right side lip droop/ weakness). The patient was treated with HYALURONIC ACID (RESTYLANE) on 27-Jan-2022 at a dose of Restylane Lyft; HYALURONIC ACID (RESTYLANE) in May 2021 at a dose of Restylane Kysse and HYALURONIC ACID, LIDOCAINE (RESTYLANE L) on 24-Nov-2021 at an unspecified dose and frequency. At the time of the report, FACIAL PARESIS (Unilateral upper right side lip droop/ weakness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The patient had unilateral upper right side lip droop or weakness. Only top right side. Lips injected with Restylane Kysse in May 2021, Restylane L injected on 24-Nov-2021. Cheeks done with Restylane Lyft on 27-Jan-22. Event started 8-Feb-2022 and was ongoing. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
intussusception.  08/26/2008 MR received for DOS 7/10-11/2008 with D/C DX:  Intussusception.   Pt presented with 1 day hx of blood in stool and abdominal pain, fever, fussiness, nausea and vomiting.  PE (+) for abdominal tenderness and guarding. Sent for air enema reduction following US (+) for IS. Reduction successful. D/C next day.
10cm firm knot, reddened, with swelling down to elbow and up to shoulder, painful to touch, no fever or crying. No complaints.
64 yo M with PMHx HTN, HLD, Diverticulitis s/p sigmoid colectomy 6/2020, and Hep C who presented as a transfer from hospital due to acute onset R sided weakness with ICH found on CT scan. History taken from patient bedside. Around 8pm last night 4/27, patient felt acute onset of numbness and weakness to his right lower extremity as he was coming out of the shower. He then tried to sleep and had a restless night. He noticed ataxia with his right leg as he tried to walk around. In the morning, his right upper extremity became numb and weak as well and he decided to go to the ED. Upon arrival, CT Head showed "Acute hematoma of L Lateral thalamus 2 x 2.6cm with surrounding edema and mass effect".
sore shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal pain (patient received 1st dose on an unknown date, refer case US2019AMR184141 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shoulder soreness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shoulder soreness was unknown.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's partner. The age at vaccination was not reported. The age group was not reported but selected as adult as per vaccine indication. The patient experienced sore shoulder after receiving Shingrix. This case has been linked to US2019169168 and US2019AMR176794, reported by the same reporter.
From initial information received on 09Aug04 from a health care professional regarding an adverse event occurring, it was reported that a 23 year old female pt received her second dose of reported that a 23 year old female pt received her second dose of Menomune A/C/Y/W-135, lot number UE123AA, administered SC in the left arm on 26Jul04. That same day, the pt developed hives on her arms, face and neck and a wheezing feeling. Reportedly, the pt recovered from these events. From additional information received on 15Sep04 from the initial reporter, it was reported that the information provided in the case report was reviewed and that there is no additional information at this time.
Rec'd vaccine at 1330. At 1800 site became red, warm to touch, swollen and sore, stated BP 11/01/06 was up 157/93, 11/02/06 site red warm and swollen at 1 3/4 inches round.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route of administration and indication were not reported, lot number# L018499 expiration date: 25-FEB-2017, L022259 expiration date: 06-APR-2017). This is one of the several reports received from the same reporter. Additional information has been requested.
Patient admitted to hospital 10/7/18 with prolonged febrile seizure requiring anticonvulsants and admission to the PICU. She was positive for adenovirus on evaluation and this was felt to be the most likely cause of her fever and seizure. She was released on 10/9. However, due to recent immunizations report seemed warranted.
Patient developed signs and symptoms consistent with a Guillain Barre syndrome like illness approximately one month following vaccination. Severe muscle weakness feeling. On Sat 2/20/2010 I was informed by the Rph that patient's wife came by the pharmacy and said that her husband was in the hospital and had been since 2/5/10. It seems that the patient had some muscular weakness and trouble walking and they think after several weeks of looking for a cause that it might be a reaction to the H1N1 vaccine possibly Guillain Barre syndrome. On 1/11/10 I provided the H1N1 vaccine to the patient. He received an intramuscular injection of 0.5 ml of Sanofi Pasteur lot UP048DA exp 09/11. He was given the required VIS for at that time as well as the info from our computer generated form. The vaccine was supplied to me as an immunization provider. This vaccine had no recalls however the company amended the expiration date to 2/15/10 due to loss of potency concerns. On 2/21/10 I called patient's wife and had a long conversation with her about her husband. She told me that he was improving and that he is diabetic and recently had a knee replacement surgery. She said that the MDs thought his condition might be related to diabetic neuropathy which he has a history of, but that due to his rapidly deteriorating condition, it wasn't likely that. She told me that the physician's think he may have developed a Guillain Barre-like syndrome, are treating him for that and that it may be the vaccine that caused it. She mentioned to me that she knows it is not our fault but wanted me to know so that I could report it to the CDC. I told her that I certainly would do that. I told her I wanted to get the report from his doctor and I would relay the info through the normal means via VAERS reporting. Patient's wife works in healthcare and has read up on the illness and understands that it (GB) has been thought to be caused by various conditions including respiratory infections, GI infections, surgery, and vaccines. Patient's wife mentioned to me that the MDS let her know that the cause of such a syndrome can not be assured but that they do see a few cases each year. I contacted doctor's office 2/26/10 to request any report that might be available before I report to CDC. He called me right back and summarized what he thought and what was reported as follows: "Pt had the chemical and physical findings consistent with a GB-like condition. Lumber findings revealed the CSF proteins you would expect. Whether it was caused by a vaccine, a fall, other illness, or his underlying small axonapathy and diabetic neuropathy we just cannot be sure."
Patient stated that her arm began to swell about 2 hours after the injection.  She rubbed and took antihistamine
This spontaneous report was received from an office manager and refers to a 18-month-old male patient. The patient had no pertinent medical history, concomitant medications, drug reactions or allergies. On 01-JUN-2018, the patient was vaccinated with VAQTA injection, dose reported as 25/0.5, intramuscularly, lot # N026997 and expiration date: 10-NOV-2018, as a "part of routine vaccinations" (frequency was not reported). The office manager reported, that the patient returned to the doctor's office "1 hour later" on 01-JUN-2018, with "puffy ears, red cheeks and hives". The patient received an unspecified dose of BENADRYL. The outcome of events was reported as recovering/resolving at the time of this report. No causality assessment was provided.