chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O28K21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Prednisone). Concomitant products included APIXABAN (ELIQUIS) from 25-Feb-2022 to an unknown date for an unknown indication.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2021 to 21-May-2021 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for Covid one week after stopping Paxlovid..         It was reported that patient had tested positive for Covid one week after stopping Paxlovid on 28 May 2022, no hospitalization Prolonged.  Company comment: This spontaneous case concerns a 75-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 4months after receiving the 3rd dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested positive for a week after completion of the treatment. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of prior Covid-19 vaccination was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 75-year-old male patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, approximately 4months after receiving the 3rd dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Following this she tested positive for a week after completion of the treatment. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of prior Covid-19 vaccination was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 04-DEC-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a severe vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Chills, fever 102.7 Fahrenheit, light headed Symptoms started 11-12 hours after receiving vaccine. First measured fever identified at 12 hours mark of 100.9....at 13 hours 101.5 at 14 hours 102.7
Breakthrough case admission after two vaccines Pfizer 3/10/21 Lot# En6207;  Pfizer 3/31/21 Lot# ER8734
After 1st shot felt sick, headache, vomiting, fever, dizzy. After 2nd shot, same but worse. After 3rd shot, bed ridden entire next day, vomiting, migranes, dizzy, confusion, depression. Vomited randomly since first shot to present. Muscle aches since shots, random bouts of dizziness since shots, fatigue since shots. 2013-bagan having symptoms of MS. Present day- symptoms worsening, numbness, feeling like skin is on fire, itching, altered vision, headaches daily.
(hives)eventually grew; a few Hives; itching on her body, feet, eyes, and lips; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (a few Hives), URTICARIA ((hives)eventually grew) and PRURITUS (itching on her body, feet, eyes, and lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (a few Hives). On an unknown date, the patient experienced URTICARIA ((hives)eventually grew) and PRURITUS (itching on her body, feet, eyes, and lips). At the time of the report, URTICARIA (a few Hives) and URTICARIA ((hives)eventually grew) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Resident recieved second dose of Moderna vaccine on 2/13/2021.  Resident tested positive for COVID-19  on 3/8/2021 which is 24 days out from last dose of vaccine.  Resident is asymptomatic.
Patient had a hard time walking the day after her immunizations, she seemed stiff and sore.  Then again, a week after her immunizations she had trouble walking, it seemed to be a stiffness in her legs all day.  That same Wednesday (Jan 14th) she started having "not normal" looking bowel movements.  Saturday morning she was vomiting and then was back to her normal self, wanted to eat and then again vomited up her breakfast, the rest of the day she didn't have a very strong appetite.  Sunday (18th), the same thing, she vomited up her morning cup of milk, and then she was ready to eat, mom put her in the high chair and she had a seizure.  Mom called 9-1-1 and the EMT's came and took her to the ER.  In the ER she had her blood drawn and was clearly upset.  She had another seizure while they were trying to catheterize her.  She was taken to have a CT scan and then admitted to the hospital.  The nurse in pediatrics said they needed to weigh her again, naked.  This woke patient up and got her upset again.  She was weighed and re-dressed and on mom's shoulder, crying and not settling down, she had another seizure.  She was put on anti-seizure medication.  MRI, EEG, blood work, urine, and CT scan all came back "normal".  She was released from the hospital on Tuesday the 20th.  She has not had another seizure and is not on anti-seizure medication. Follow up received 03/15/2010. So far, to date, she has not had any adverse reactions. We will not be vaccinating her any further. Nor will we be vaccinating her 7 mo. old brother. I think vaccines should be on a case by case scenario & tailored to each individual's needs & circumstances. Also, what sort of accountability do these companies have for these reactions. Thanks!
Site: Pain at Injection Site-Mild, Additional Details: patient started experiencing blurry vision in his left eye only, starting 2 days after 2nd shot. pt says no problems after 1st one.
Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash; right inguinal large tender lymphadenopathy appeared same time; fatigue; muscle aches; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) via an unspecified route of administration on 12Jan2021 14:00 at single dose in left arm for COVID19 immunisation. Patient age at time of vaccination was 56 Years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) administered on 22Dec2020 at 14:00 in left arm. The patient has allergies to Duricef, milk, almonds. Prior to vaccination, the patient was diagnosed with COVID-19. The patient received unspecified concomitant medications. On 13Jan2021 the patient experienced Shingles left sacrum along S4 with pain radiating to left medial thigh down to left medial knee; rash appeared 18 hours after 2nd Covid vaccine; right inguinal large tender lymphadenopathy appeared same time; also had normal fatigue, muscle aches from vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. As treatment for the events the patient received Acyclovir 800 mg QID x 7 days and terrasil ointment. The events were reported as non serious. Since the vaccination, the patient has not been tested for COVID-19. The events had not resolved.
Pt states that the site of injection was swollen and sore the evening right after vaccine administration. The following morning, pt presented to pharmacy and the area of injection appears swollen and bruised.  Pt states that the right arm feels uncomfortable.
This spontaneous report as received from a registered nurse refers to unknown number of patients with unknown age and gender. On unknown dates the patients were vaccinated with ROTATEQ lot # K004795, expiration date: 11-FEB-2016, route was default as oral, (strength, dosage and frequency were unknown). There was temperature excursion during vaccine storage. The patient was vaccinated at private doctor's clinic/hospital with public funds. The manufacturer was contacted. Vaccine was stable and no adverse event was observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
I could not work but my knees hurt so bad. I had an arthritis pain in my joints, wrist knee and my fingers. I was in a lot of pain and limping at the end of the day. I went to the ER and they did tests. A few days later I developed a rash on my thighs and when it started to spread to the other thigh. It looks like hives and it is was very itchy. The rash then appeared on my buttock and then to the other side. It proceeded to spread in patches in different areas of my body and then spread to the contralateral side of the same body area. I had swelling in my right hand on two fingers.  A month after vaccination I also got a fever. All tests were negative except my CRP was elevated each time. I was prescribed Prednisone, but the rash still appears periodically, and my joints still hurt after 12 weeks. The rash is not as itchy when it appears. I have had another course of Prednisone after seeing the immunologist.
Information has been received from a woman concerning her husband, a 48 year old male who in 12/99 was vaccinated with the 2nd dose of Hepatitis B vaccine recombinant. On approximately 01/06/00, the patient experienced a rash "all over, not just in a specific area". The rash started on the patient's hands. The rash was itchy, and he had 30 spots on his body. They were pus filled and irregular in shapes. They were not huge, and were smaller than a dime. The reporter stated "if he did not already have the chicken pox I would think it was that". The patient's varicella-like rash persisted. No further information is available.
LVN meant to give DTaP but gave KINRIX instead. Therefore, patient received DTaP but received an additional dose of IPV.
No symptoms right after the shot. 6 days later spike in blood pressure to 170/110 went down but happened again 2 days later then happen again today 154/112 was today the 19th.   I am 38 years old and have never had blood pressure issues
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. It was reported that 1 or 2 weeks ago (approximately 17-JUL-2012) the patient was vaccinated with subcutaneously in right arm with a 0.5 ml dose of PNEUMOVAX23 (dose, route), lot# 1947AA. On an unknown date in 2012 the patient experienced red arm, swollen and painful arm. The outcome was not reported. This is one of several reports from the same source. Additional information has been requested.
My COVID-19 symptoms were very mild. It started on the 7th with a scratchy throat as if I was coming down with a cold. Next day I had a little sinus congestion which is normal. I tested positive on the 8th. I then had runny nose, sinus pressure, had the sensation that my arm hairs were standing up; my left leg then felt very heavy. Within 5 days all the symptoms had resolved. The sensation with the arm hairs and heavy leg also came after both the vaccines.
Info has been received from an NP concerning a 10 year old male who in 10/97, was vaccinated, SC with a 0.5 mL dose of varicella virus vaccine live (lot 624063/0958F). "Recently", in approximately 8/05, the pt presented with chickenpox with about 40 lesions. The pt was not experiencing a fever or any other illness. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Pain at injection site, extreme weakness, headache, muscle pain, joint pain, nausea, back pain.
Patient reports history of passing out with lab draws and one other time with injection. Within 30 seconds of vaccine, patient reported dizziness, narrrowed vision, and diaphoresis; he also appeared very pale.  As we attempted to assist him to the floor, his eyes rolled back and he lost consciousness. Patient became alert within 10 seconds of losing consciousness. When safe, he was assisted to WC and taken to clinic where he was observed for a few hours. Patient discharged home with his mother when he was feeling better.
Hospitalization: 9/7/22 ADMIT, 9/10/22 DISCHARGE. Presentation to the ED: COUGH X 6 WEEKS W/ SOB.  COVID-19 + date: 9/7/22. Treatment: will avoid remdesivir for now as the patient does not have any worsening oxygen requirements. DEXAMETHASONE.  Discharge to: HOME.
Report of awakening with difficulty concentrating, fearfulness, and confusion.  Medical work up unremarkable.  Symptoms are gradually resolving today, 12/31.
an expired Daptacel dose that was given to patient/ No AE; Initial information was received on 24-Jan-2020 regarding an unsolicited valid non-serious case from other-healthcare professional.  This case involves a 20 month old male patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment, vaccination and family history were not provided.   On 23-Jan-2020, the patient received the first 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5Z06AA, expiry date - 17-05-2019) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, 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 in Directive and Module VI of the Practices. 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.
Chest pain, Pain on breathing deeply, numbness and tingling in left arm, hand, leg, foot
Baby cried for 4 hours right after the shot was administered, and the site was swollen.
MACULAR RASH ON BOTH ARMS, NECK; DENIES RESPIRATORY SYMPTOMS.
diffuse rash - appearance is consistent with pityriasis rosea but onset occurred within 24 hours of vaccine administration and has spread since onset
Chest pain (8/10), mild nausea, worse with movement.Medical records state arrhythmia, junctional. msv
Pt was given immunization in right deltoid 08/15/2016. Presented following day 08/16/2016 to walk-in with warm, red, slightly itchy arm. Inj. site was reported to be normal looking, with no evidence of infection, no drainage, discoloration or swelling. Pt was encouraged by nurse to apply ice pack and take BENADRYL if needed, follow up if any shortness of breath, difficulty breathing, and/or worsening of symptoms.
Patient reported fever and chills starting the evening of the vaccine, patient reported that she took TYLENOL for the fever and her symptoms were resolved by 4/14/2018.
At 4:15pm 11/7/08 pt received FLUVIRIN vaccine. About 5 minutes after pt noted feeling peculiar. No visible observable signs of anaphylaxis. 911 was dialed pt was fully responsible at all times. EMS service noted blood pressure at 195/101. Transported pt to ER.
About two days after my vaccine I developed swollen lymph nodes in my right armpit and it lasted three months and then went away, No treatment was sought.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concurrent conditions, medical history, or concomitant medications. In 2012, a healthcare provider at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination of Pfizer 1,2, and boosters x2. Last booster was 05/24/2022.
Initial report received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. The report involved a case of misuse. A case of pertussis disease in a 2-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL received on the following dates: 20 April 2010, 27 May 2010, 01 September 2010 and 26 May 2011 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 03 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I had severe muscle and nerve pain, as well as numbness, mostly on the right side of my body, worse on my thighs.; I had severe muscle and nerve pain, as well as numbness, mostly on the right side of my body, worse on my thighs.; I had severe muscle and nerve pain, as well as numbness, mostly on the right side of my body, worse on my thighs.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (Pfizer- BioNTech COVID-19 VACCINE, solution for injection, Batch/ Lot number: EW0187) via an unspecified route of administration, administered in left arm on 21May2021 15:45 (at the age of 51-year-old) as Dose 1, Single for COVID-19 immunization. The patients medical history included Hepatitis B + but no symptoms and normal liver functions, and Known allergies to feathers. The patient received other medications in two weeks included (MULTIVITAMINS [VITAMINS NOS]) for an unspecified indication (regular multivitamins). The patient previously took oxycodone, lactose, silver and experienced drug allergy. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. On 22May2021 08:45, the patient experienced she had severe muscle and nerve pain, as well as numbness, mostly on the right side of her body, worse on her thighs. Adverse event resulted in doctor or other healthcare professional office/clinic visit. She received treatment as Acupuncture/biopuncture. The outcome of events were recovering.  Follow-up attempts are completed. No further information is expected.