chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; fever; vomiting; chills; headache; This is a spontaneous report from a contactable consumer(parent). A 12-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17Jun2021 as a single dose at the age of 12-years-old for covid-19 immunisation. Medical history included crohns disease from May2018 to an unknown date and now he is currently in remission and doing well. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation and had no reaction. Concomitant medications included famotidine (PEPCID), vedolizumab (ENTYVIO), vitamin C and a probiotic all taken for crohns disease from an unspecified start date and ongoing. On 18Jun2021 patient experienced nausea and vomiting in morning and also had a fever, chills, headache. The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
ALL SIDE EFFECTS; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced all side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of all side effects was not reported. This report was non-serious.
This spontaneous report was received from a nurse refers to an unspecified female patient of unknown age. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with first dose of GARDASIL, (lot #, dose, frequency and route not provided) and in 2014 (also reported as a year ago), the patient received the 2nd dose of GARDASIL. On 22-SEP-2015 (today), the patient was currently in the office to receive her third dose of GARDASIL; which was outside of the recommendations in the GARDASIL prescribing information. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Pt has pain that radiates from her shoulder to mid-arm which has lasted > 5 weeks post shot. Her doctor recommended ice packs, but has not helped.
A solicited report has been received from a Health professional concerning a patient of unknown gender and ethnicity. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. Registered Nurse reported that a child received FLUMIST QUADRIVALENT (intranasal) in 2013-2014 season and tested positive for Flu A in Nov 2013. Action taken was not applicable for FLUMIST QUADRIVALENT. The outcome of the event of tested positive for flu A in Nov 2013 was unknown. The event tested positive for flu A in Nov 2013 considered to be non serious by the reporter. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of tested positive for flu A in Nov 2013 with suspect drug FLUMIST QUADRIVALENT to be unrelated.
Patient called 10/26/22 to report that she received covid-19 bivalent, flu HD quadrivalent, and shingrix dose 1 at 9:52 am on Monday 10/24/22. She stated that Tuesday evening (she did not say what time) that she was at a friends house and felt nausea, light-headed, and her friend told her she passed out. She doesn't believe she passed out for long but isn't sure. Her friend called 911, but patient refuse to allow them to come check on her and the call was ended. The friend used an automatic BP monitor to check on patient and according to patient her blood pressure was normal. She then felt cold and chills/shakes for about an hour. The adverse reaction resolved fully by the time she notified the pharmacy 10/26/22 around 3pm. She said there was no irritation at the injection sites and was concerned about why it happened -possibly due to multiple vaccines.
Pt received vaccines in supine position. Pt received TIV in L arm. Pt received HPV in R arm c/o nausea, CMA placed a cold pack on pt's neck and took sip of H2O and asked RN to come into room. Held off giving H1N1 for 5-10 minutes, at pt's insistence gave H1N1 and within seconds pt developed syncope became rigid then jerking of arms and legs with paused breathing for 15 sec. Pt responded quickly alert and oriented.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Oct-2013. It was reported that patient received FLUMIST quadrivalent over age 49 on 16-Oct-2013. The outcome of the event received FLUMIST quadrivalent over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from health professional: Last name and reporters address of reporter administered by were added.
10mins post vaccination, pt states "my throat feels swollen, like I have a bubble" Vitals: @18:42 BP 104/64, HR 75, RR 20, 100% O2 sat -- > @18:52 90/51 -- > @18:54 90/50 Pt discharged @19:10, accompanied by mother in wheelchair and 2 RNs.  Pt walked to car from wheelchair in stable condition.  Mother educated on S&S to watch for and advised to seek medical attention for any medical needs.  Mother verbalized understanding.  Pt stable and released from vaccination site.
shoulder was sore; on his right leg below his groin area on his thigh he states there is a place about 8 inches in diameter that aches if he puts pressure on it; his right thigh, not near the joint, but 4 inches down the right thigh area, he describes a big circle that is sore.; This is a spontaneous report via Pfizer- sponsored program Covax US support. A contactable consumer (patient) reported that a 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 2 via an unspecified route of administration on 21Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first single dose of bnt162b2 on 28Feb2021 single for Covid-19 immunization. Patient took second dose on 21Mar2021. his shoulder was sore for about a day after the second dose, however, on his right leg below his groin area on his thigh he states there was a place about 8 inches in diameter that aches if he puts pressure on it. He states that this was still bothering him and he wants to know if this is a common reaction. on 02Apr2021, when the vaccine had been in full effect for 10 to 14 days, he states his shoulder hurt, and then went away. his right thigh, not near the joint, but 4 inches down the right thigh area, he describes a big circle that is sore. when he walks he feels it on his thigh and he got it a few days after the second vaccine. starting 02Apr2021 top of right thigh was sore when he puts weight on it. The patient had recovered from the event shoulder pain in Apr2021 and rest of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Felt tired, had muscle pain, headache, shivering, fever. Bed rest for two days. Back to normal.
fully vaccinated on 12/30/2020 and 01/20/2021. tested positive for COVID on 08/22/2021
15 minutes following COVID vaccine administration pt observed to have periorbital erythema and edema. Pt administered 25mg/10ml diphenhydramine. Erythema and edema improving, increased pt wait time to 30 minutes. Pt left observation area in good condition.
Worsening of peripheral neuropathy, pain mostly. Hemifacial spasm.
Presented to Er on 11/13/21 and was admitted.  This is a 74-year-old female with a prior history of CKD stage IIIB, dilated cardiomyopathy with ejection fraction of 25-30% and post ICD placement, insulin-dependent diabetes mellitus type 2, hypertension, chronic systolic congestive Heart failure who is vaccinated for COVID-19 and presenting with complaints of cough.  She did test positive for COVID.  Workup in the ED did reveal the ABG with the pH that was within normal limits, PO2 of 62.9 pCO2 of 46.6.  Oxygen saturation was 90.7 on room air.  X-ray did reveal no acute cardiopulmonary disease.  CT chest without contrast did reveal mild peribronchial thickening likely suggestive of bronchitis otherwise no focal pneumonia or ground-glass disease.  Initially she was started on Rocephin azithromycin Decadron as she was mildly hypoxic and tachypneic.  She did significantly improve overnight.  Continue to have a cough that was predominantly nonproductive.  She however remained stable on room air.  Therefore was stable for discharge.  O2 walk was performed prior to discharge and now patient did not require any supplemental oxygen.  She was discharged on a course of azithromycin. Discharged on 11/14/21
Patient received 2nd dose of Pfizer COVID vaccine approximately 1:00pm. Around 1:15 pm staff were alerted by patient's father that he was having a seizure in the car. Staff went to assess situation, no seizure activity was noted at that time. Patient was lying on his left side in the back of truck, vomit present on truck seat and in patient's nares. Patient has a history of epilepsy. Pulse ox was 78 and HR was 136, and there was concern for aspiration. Pt was placed on oxygen while waiting on ambulance. Oxygen sat improved up to 94% on 4L of oxygen, HR continued in 130s. He was stable when ambulance arrived approximately 15 minutes later, and he was transferred to the hospital.
This spontaneous retrospective pregnancy report as received from a female pharmacist refers to herself as a patient. The patient had no concomitant medication, pertinent medical history and drug allergies/reactions. The patient was vaccinated with two doses of VARIVAX (Merck) (dose, route and lot# were not provided) on unspecified dates in the year of 2011. The patient reported that her gynecologist drew titers on an unspecified date in 2011 and the results showed a low titer. She also reported that at the time the titers were drawn in 2011 she was pregnant. The last menstrual period (LMP) and expected date of delivery (EDD) were unknown. The pregnancy outcome was unknown, but she stated that she was not pregnant at the time of the report. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
First shot 2 years ago, not advised to get a 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. This case was reported by patient's wife. Till the time of reporting, the patient did not received 2nd dose, which led to incomplete course of vaccination. This case is linked with the case US2021AMR187241, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR187241:Same reporter. Reporter's case.
chills; aches; sore throat with a fever of 99.9; sore throat with a fever of 99.9; As well as a headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 07Feb2021 at 10:45 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Other medications (concomitant) in two weeks included buprenorphine hydrochloride, naloxone hydrochloride (Suboxone) taken for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Jan2021 at 10:45 as single dose for COVID-19 immunization. On 08Feb2021 at 06:30, when patient woke up the day after his vaccination, he experienced chills, and aches. Also, a sore throat with a fever of 99.9 as well as a headache. Patient did not feel like it would get better very soon. It was unknown if the patient received any treatment in response to the events. Outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Patient fainted 20 minutes after immunization was given. Patient complained of feeling hot and dizzy. No loss of LOC. Patient went home after 30 minutes feeling good.
I was exposed to COVID-19 on July 6, 2022 so I tested that evening using my home COVID-19 test it came back negative. On July 8, 2022 I woke up with a scratchy throat took a home COVID-19 test it had a faint positive line so I went in to the local urgent care they used a rapid COVID-19 test that came back positive. I came home and quarantined from everyone. I took over the counter medications, MUCINEX, elderberry gummies, TYLENOL. I had a slight cough, headache.
Fever, chills, muscle aches/joint pain, 2 days Swollen/painful lymph glands on injection side, 3 days
Skin below eye (near sinuses) was swollen, red, and tender to the touch Tuesday morning. On Wednesday morning it had spread down to his upper lip and across his nose to the right of his face.
Headache, Myalgia & Fever Narrative:  missed work following 2nd dose due to above symptoms
On 8/7/00, the child received his 1st injection of Infanrix. On that date, he also received his 2nd injection of MMRII and his 1st injections of varicella and IPOL. On 8/10/00, the pt experienced left testicular swelling, mild erythema of the left scrotum with generalized tenderness and swelling. The pt walks with legs slightly abducted. The pt's dx was orchitis. The pt's mother stated that "we can only conclude that it was a reaction to the vaccine". He was seen by a pediatric urologist who reported "that there had not been a documented case of this type of reaction in a juvenile in over 17 years". The reporter considered the pt's experience to have resulted in a significant disability. Follow-up information from a nurse, stated "she vaguely recalled this child's experience and believed he had seen a pediatric urologist who was not the primary physician treating the pt for this experience". The nurse also stated "she thought it was the urologist who felt the child's orchitis was related to MMRII vaccination, though she was not certain of this". She also stated "that she believed the child walked with his legs abducted due to the testicular swelling and orchitis and this was not a separate experience but again she could not definitively state this without checking the pt's chart". Outcome of the orchitis was not provided.
Dormant sarcoma came out - had never had cancer before and now it blew up and had to have surgery; lung nodules grew in size; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. Lot unknown reason=Not available/provided to reporter at the time of report completion. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVODOPA. Vaccination history included: Bnt162b2 (Dose number=2, Product=COVID 19, Brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Product=COVID 19, Brand=Pfizer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. Other vaccine in four weeks was reported as no. Covid prior vaccination was reported as no and covid tested post vaccination was reported as yes. The following information was reported: NEOPLASM MALIGNANT (hospitalization, disability, medically significant, life threatening) with onset 30Sep2021 at 03:00, outcome "not recovered", described as "Dormant sarcoma came out - had never had cancer before and now it blew up and had to have surgery"; PULMONARY MASS (hospitalization, disability, life threatening) with onset 30Sep2021 at 03:00, outcome "not recovered", described as "lung nodules grew in size". The patient was hospitalized for neoplasm malignant, pulmonary mass (hospitalization duration: 2 day(s)). The event "lung nodules grew in size" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of neoplasm malignant, pulmonary mass. Ae treatment was reported as surgery for removal. It was reported that Ae resulted in: Doctor or other healthcare professional office/clinic visit. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Headache, dizziness, weakness, muscle soreness, shivering (chills),
The patient was exposed to his older brother who experienced wild type varicella. On approximately May 20, 1999 the patient developed a mild course of chickenpox. The MD noted that the lesions were smaller and fewer were fluid filled than the older brother's. The pt did not require treatment.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, NauseaVomiting, chills, sweats,  Narrative:
covid-19 prior to Paxlovid treatment; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid-19 prior to Paxlovid treatment) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergy to unspecified drug.).   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19 prior to Paxlovid treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 antibody test: positive (Positive) Positive(1st occurrence) and positive (Positive) Positive (after paxlovid treatment).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient previously received a COVID-19 vaccine. It was reported that patient received first dose on 08-Apr-2022. In 2022, patient tested Covid positive and received Paxlovid treatment. Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient was again tested positive after treatment with Paxlovid. Device date was reported as 31-May-2022.  Company Comment: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient tested positive again for covid-19. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with paxlovid patient tested positive again for covid-19. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Neck stiffness; Headache; Dull pain in eyes; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration on 19Jul2021(at the age of 51-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration on 09Aug2021 at 17:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unknown date in 2021, the patient experienced neck stiffness, headache and dull pain in eyes. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events neck stiffness, headache and dull pain in eyes were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Moderate local rxn to ANTHRAX vaccine. Erythema 10 x 11cm. SQ nodule 1.5 x 2 cm. TX = MOTRIN, LIDEX ointment.
ARM GOT SWOLLEN FROM DELTOID DOWN TO ELBOW. THE PATIENT ALSO EXPERIENCED A FEVER. THIS ALL LASTED FOR A COUPLE DAYS
I got COVID. For a week I had shortness of breath, cough, fever, joint pain, I was fatigued. I wasn't able to leave the house or walk up and down the stairs because of the shortness of breath. What made me go to the ER was that later at work I was having chest pain. They found residual damage to my lung because of COVID and pneumonia.  I did an at-home test that came back negative. I did a PCR test that came back negative.
on day vax given mom had difficulty waking pt;mom also states pt stopped breathing;pt was taken to ER;T99.3 R;pt was active & crying a lot;pt tried to take formula but vomited;