chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 10:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 at 10:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 10Oct2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 28Mar2022 at 12:00 as dose 4 (booster), single (Lot number: AC9895) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic inflammation" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 13Jun2022. Stop date of treatment for COVID-19 was 17Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a consumer concerning her son who was vaccinated with a dose of MMR. Subsequently, the patient developed autism. At the time of the report, it was noted that the patient was 4 years old. Upon internal review, autism was considered to be an other important medical event (OMIC). It was also noted that the patient's brother developed autism after vaccination (WAES0508USA01817). No additional information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received treatment for covid-19 with Paxlovid from 12may2022 to 16may2022. The patient also received fourth dose of moderna vaccine for covid-19 immuniation.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the Vaccination failure and Covid-19 for the suspect vaccines cannot be excluded. However, the efficacy of a drug varies from patient to patient and can be affected by different factors.
heart beat was faster; accumulation of wax in ear; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-May-2021 and was forwarded to Moderna on 21-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007621A and 026C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 20-May-2021, the patient experienced HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear). At the time of the report, HEART RATE INCREASED (heart beat was faster) and EXCESSIVE CERUMEN PRODUCTION (accumulation of wax in ear) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-162141 (Patient Link).
Pt. record noted patient was given full Adult dose, even though only 5 years old.  Our clinic has no record of receiving care at our facility nor is a patient under our care.  Apparent mis-entry by another authorized vaccinator that chose the wrong vaccinator designation.
Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: during the 15 minutes waiting time patient complained of lightheadednes and dizzines. i helped patient to lay on the floor and mesured her bloodpressure and it was normal , after about 5 minutes patient is not feeling any better and her blood pressure dropped . after 5 more minutes patient was still struggling with her low blood pressure and starting to have stomach issues and felt anurge to have a bowel movement.911 operator advised agianst any food, water or meds untill emt arrives.
A rash that looks like Contact Dermatitis, appeared in my R foot approximately 3 days after I received the first dose of the Pfizer vaccine.  Within a couple days of noticing the first blotches on my R foot, the rash begins appearing on my legs, from my calf up to and on my knees. R leg being worse than my L.  I began using a Cortisone ointment that has helped a small bit.  The itching and the skin bumps itch, especially when the sun hits my legs.
a period of atypical, inconsolable crying following 2mo immun; 3-4 hr induration; symptomatic care no other treatment than acetaminophen given resolved w/o apparent sequellae next AM;
two days after I got the shot my arm swelled up. Ihad swollen lymph glands and body chills and fever and stiff neck
On March 11 at 1:50 PM I got the shingle shot at the Pharmacy. Instead of just a prick when I got the shot, I felt the complete injection. At 3:30 PM we went to the Movie Theater. At about 4:30 PM my upper left arm began to hurt while at the theatre. By 5:00 PM, I started having trouble breathing. And by 5:30 PM my whole arm was sore, I couldn't lift it, and I was having a harder time breathing. I had to put my head down low in front of me to get my breath at all. At about 5:50 pm I asked my husband to call 911 for EMS. At about 6:00 PM the EMS arrived; I was put on a gurney, put into the EMS vehicle, and taken to Medical Center. During the 30 minute drive to the hospital, EMS gave me oxygen and an intravenous solution as my blood pressure was very low, prox 90 over 48. As I was still having trouble breathing, the oxygen level was increased above normal. They were also monitoring my heart. My breathing finally became easier just before arriving at the hospital about 6:40 PM. Dr. was my emergency physician at the hospital. The left arm continued to be very sore and I could not lift it on my own without actually pulling it up with my right arm. ER gave me an IV, an EKG and upon my request TYLENOL for the pain. They also were taking my blood pressure regularly. The TYLENOL helped some, but I still could not lift my left arm. I was released about 8:30 PM and told not to get the 2nd Shingles shot. The next day I reported my experience to my pharmacist of Pharmacy, and he was going to report it to the drug company. He also advised me not to get the 2nd shot. 3 days after the shot, on Mar 14th, I saw my physician, Dr., as ER told me to. He had access to all my ER records. Since my only known allergy in 82 yrs has been sulfa, he felt I must have had a reaction to one of the fillers in the shot. It was noted that I had had the live vaccine shot for shingles several yrs ago with no reaction at all. He also advised me not to get the 2nd shot. It took a whole week before the arm was not painful and until I could raise the arm up somewhat higher. I did exercises with the arm every day to try and increase my ability to move it up and around my left hip and up to my right shoulder. I took 2 TYLENOL every morning and every night for 10 days. My left arm mobility has improved, but still not normal 3.5 weeks after the shot. Fortunately I am right handed!
MA is documenting the vaccine she gave, she realizes she gave the wrong vaccine, around 1530.  She gave Menveo instead of Bexsero, Men B. Pt has already got 2 doses of Menveo, with the last dose given 6/28/22.    Dr. notified.    MA telling the patient and step- mother of vaccine error. Discussed extra dose of Menveo was given when it was not needed. Apologized that it was done in error. Discussed Dr.  wants to err on the side of caution and wait to give Men B for another month. Pt sitting in chair in no distress. Both pt and step mother are aware to call the clinic for any concerns that happen after leaving or develop over the weekend. Both verbalized understanding and agreed to plan.     VIS for Men ACWY given to pt and checked on patient around 1541. Pt still in no distress and reports he is fine. Dr. in the room with the pt.    Pt left the clinic ambulatory.
This is a spontaneous report from a contactable consumer. A 80-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6201, expiration date not reported), via an unspecified route of administration, on Mar 8, 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had no other vaccine in four weeks. Historical vaccine included the flu vaccine (formulation, batch/lot# and expiration date not reported), via an unspecified route of administration, on an unspecified date of 1957, for an unknown indication and had a violent reaction to flu vaccine. Patient has not tested for COVID-19, post vaccination. On Mar 14, 2021, patient had a thickened tongue towards back of throat that did not impede breathing. On Mar 18, 2021, patient's chin blew-up to size of 2 grapefruits. She had no appetite and no energy. On Mar 22, 2021, patient saw the dentist and got amoxicillin for 7 days. On Apr 13, 2021, patient's chin again blew-up, but now it was the size of ½ a grapefruit. She went to dental surgeon who stated it was not dental-related. On Apr 21, 2021, patient had an ache in her ears and throat. Again she had no energy. On Apr 28, 2021, patient felt better. Patient had doctor or other healthcare professional office/clinic visit for all the events. Treatment/therapeutic measures taken as a result of all the events included amoxicillin. The outcome of all the events: recovering. No follow-up attempts possible. No further information expected.
Approximately 24 hrs after vaccine I developed a rash on lower right forearm. The rash worsened over the next 4-6 days spreading over most of the right arm, also in neck area, and around waste band area. Right arm became swollen. Treated with topical cortizone 10 cream and aloe vera. On begining of week notified Dr that rash was getting worse and arm swollen. He prescribed Benedryl 25 mg tablets 3 times daily and prescribed MethylPrednisolone tablets 4 mg per tablet in 6 day taper pack. That treatment started today Wed 3/24 at 3PM.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information were reported.
Localized swelling, bruising, and warm to the touch at site of injection and surrounding area. Possible low-grade fever- reported being warm to the touch.
She started having headaches about 20 days after her first Covid vaccine (Pfizer) on February 3. She then developed severe headaches after the second dose (3/1/2021). Initial headache was left-sided and felt like a pulsing sensation in the mid parietal area. After the second vaccine she developed the diffuse headache in the area of the temples. The headache is worse at night. She talked with the neurologist on March 13 after the second dose, but the headache had subsided at that time. The headache started again last week, around March 23. It is pulsing sensation in the left parietal area and pressure across the forehead.
patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine.).    No concomitant medication information was reported.  It was reported that Limited Adverse Event reported The caller is a representative for a county.The caller wanted to find out if a lot number of Moderna Covid-19 vaccine is Monovalent or Bivalent.Agent offered to escalate his case. Caller declined the escalation and the caller said that he has another way to check what vaccine that the patient received Monovalent or Bivalent. The caller did say that when the patient went back to the Pharmacy where she received her first Moderna Covid-19 vaccine to receive her second Primary Series Moderna vaccine dose that the Pharmacy would not give her the second dose because they told the patient that she had received the Moderna Bivalent Dose as the first Primary Series vaccine. It is still not clear if the caller received monovalent or bivalent vaccine for her first Primary Series dose.   No treatment medication information was reported.
On the 29th of Nov. while going down stairs my legs (thighs) began to burn like needles were sticking to them. By 5 pm that evening I could not walk - had to call EMS - to go to hospital. Admit to hospital 12/1/2012 - Stay one week. Attending physician who diagnosed problem: Neurology. After leaving hospital I could not go home, because I needed care. Stayed with family also, I began a yr of rehabilitation (so I could walk again). Even now I cannot move toes on my left foot.
Body aches, headache, numbness to extremities, chills, fever, difficulty swallowing, difficulty moving/walking, cyanotic bilateral hands.
right leg: sore, pinkish, swelling, puffiness, sore walking and climbing steps dr. visit, on March, sent to ER for ultrasound, admitted to ER for visit and tests Deep Vein Thrombosis in right leg and superficial blood clots in right leg diagnosed eliquis prescribed for 3 months
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other: Moderna; Dose number: 04; Patient Drug Start Date: 01Apr2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Lot number: EW0151), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0179), in left arm and on 31Oct2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 026L21B), in right arm and on 07Oct2022 at 16:00 as dose 5 (booster), single (Lot number: 066F22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE MOFETIL, start date: 01Jan2012, stop date: 17Mar2023. Past drug history included: Tramadol, reaction(s): "known allergies: Tramadol", notes: known allergies: Tramadol. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "vaccine brand other: Moderna; Dose number: 04; Patient Drug Start Date: 01Apr2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive, notes: Then 5 days after that am testing positive for COVID again; (17Mar2023) Negative, notes: Tested negative 6 days after Paxlovid treatment began. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid was used from 07Mar2023 to 11Mar2023 for treatment of COVID-19. Tested negative 6 days after Paxlovid treatment began. Then 5 days after that am testing positive for COVID again.
From telephone contact received, on 08/28/2002, an adult female reported that she had a severe reaction after administration of the 4th dose of Imovax post-exposure rabies series in March, 2002.  She reported she turned black and blue, developed severe arthritis and that both of her knees need surgery.  She stated she had filed a report with the CDC.
Dizziness, headache, eye pain, nausea, muscle pain, fatigue.
GBS preceded by stomach flu late NOV & cold;late Dec-JAN GBS treated w/steroids & plasmapheresis;
I have not been ill in years, not even a cold. Since vaccine I have had multiple cold-flu-like illnesses at least monthly. The most recent occurred in early September. Now, on 9/20/21 it is becoming6 increasingly hard to breathe. I can no longer do my once-daily workout or even climb a simple flight of stairs without struggling to breathe.
7 days post vax pt localized ache & weakness lt arm 5/3/99 ?weakness lt hand;lt arm 2 small bruise marks;c/o pain can't move arm;rash on arms;c/w eczema;also arthralgia, paresthesia, inc numbness;neuropathy,myopathy, GBS, spinal lesion;
pt recv vax & devel an inj site rxn,characterized by redness & induration;this is one of seven patients from this site who exp the above rxn;
Started feeling congested with sinus pressure. Took a home COVID-19 test and was positive. Called doctor and was prescribed steroid pack and TESSALON PERLES. Started feeling better within the next couple of days.
Adacel, ActHIB, Daptacel and opened IPOL that reached 54 degrees F. for 15 hours vaccine at 1730 on 23JUL2019. This morning, 24JUL2019 at 0845 the refrigerator door was discovered to be open; Initial information received on 24-Jul-2019 regarding an unsolicited valid non-serious case received from a Consumer.  This case involves child male patient who was vaccinated with IPV (VERO) lot NIG51 (Expiry date 02-Aug-2019) on 23 July 2019.  It was reported that there were unopened HIB (PRP/T) VACCINE lot UI990AAA (Expiry date 01-Apr-2020), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5254AA (Expiry date 14-Mar-2021),  DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6214AA (Expiry date 18-Sep-2019) in the refrigerator.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage, it was reported that Adacel, ActHIB, Daptacel and opened IPOL that reached 54 degrees F. for 15 hours vaccine at 1730 on 23JUL2019. This morning, 24JUL2019 at 0845 the refrigerator door was discovered to be open.  It was reported that, no adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.   List of documents held by sender: none.
Shortness of breath, chest pain at 1600, progressively worsening with SpO2 of 87% on room air noted at 1830. Pt responded well when placed on 10L O2 via non-rebreather, sx decreased, gradually resolving.  1 Gm IV Paracetamol (acetaminophen) and 20mg IV Omeprazole administered. Pt admitted overnight for observation. Discharged the next morning with Ventolin inhaler.
Moderna COVID-19 Vaccine EUA I have a swollen lymph node on my collarbone on my right side, the same side as the injection site. It is tender and started on 4/23/21.  I have covid-arm.  My right arm is red around the injection site and feels bruised again. It is warm to the touch.  This started on 4/24/21. I also had a tender muscle around my left eye. I dont know if it is related to the vaccine, but it lasted from 4/18/21 to 4/22/21.  I used some saline eye drops think it was dry eye.  It didn't help much and then the symptom just disappeared. After my eye got better, then I got the swollen lymph node and small rash on my arm.
Swollen, redness, itchiness surrounding the area of injection. Body tremors,  distorted vision
pt recvd vax; mom stated devel a screaming cry 2-3 hrs p/ immun on 14nov94;
Admitted to the hospital with weakness, fever on 4/14/2021. Transferred to ICU on 4/17/21 requiring bipap. Intubated 4/25/2021. covid + 4/2/21. Last vaccine dose completed 3/3/2021. Pt died on 5/15/2021