chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 03Apr2021 as dose 2, single (Lot number: ER8734), in left arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine", notes: known allergies: Compazine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Negative; (20Jul2022) Positive, notes: Did not test negative again until 27Jul2022 in the morning; (27Jul2022) Negative. Therapeutic measures were taken as a result of covid-19.  Clinical Course: The patient had anti-viral Paxlovid (Lot number: GA9630) treatment for COVID-19 from 11Jul2022 and treatment was stopped on 16Jul2022. The patient had COVID symptom relapse after completing Paxlovid. Last Paxlovid dose was on 16Jul2022 in the morning. Negative COVID test on 18Jul2022 in the morning. Positive COVID test and return of symptoms on 20Jul2022 in the morning. The patient did not test negative again until 27Jul2022 in the morning. The patient had some lingering COVID symptoms. The patient had adverse event which stated on 20Jul2022 06:00 am of which outcome was recovering. The device date was 30Jul2022. The patient also had other medications within 2 weeks of starting COVID-19 treatment - Humalog (Insulin), Humulin N (Insulin), Sertraline, Simvastatin, Levothyroxine, Losartin, Multivitamin, Probiotics, and Vitamin C.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association and lack of effect the causal association  of suspect cannot be excluded for reported  events.The impact of this report on the benefit/risk profile of the Pfizer product 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
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE
had a sore arm for a few days following the vaccination. Then she felt completely normal and fine. 12 days after the vaccination, on Wednesday August 4, she woke up feeling fatigued, with muscle aches in shoulders and neck, her head felt heavy (no headache), and her left arm was sore where she got the shot. Temperature was normal. The next day her head felt better but other symptoms remained the same. Additionally she complained of joint pain Tylenol didn?t seem to help. At the end of August 5, I talked to a doctor via telehealth who recommended to treat with ibuprofen and if not improved in 24 hours to call back. I gave her one dose of ibuprofen and prayed for her to feel better. She woke up the following day feeling completely fine.
25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient received Moderna Covid-19 vaccine as booster dose The vial was initially stored in the refrigerator on 29-Apr-2022 and 04-May-2022. Treatment information was not provided.
Received Tdap, #2 dose of Hepatitis A, and #2 dose of Varicella on August 7, 2006. On the morning of August 11, 2006 she developed fever, stomach cramps, vomitting, joint and lower back pain. Mother denies any rashes. Mother reported that her other two children also received vaccines on August 7, and developed similiar symptoms, one on August 10, and the other on August 11. Mother states that symptoms are resolving.
I had all the normal symptoms from day one fever fatigue after 12 hours, but I felt strong headache after 30 minutes to an hour I had a skin rashes on 2nd day ( small rashes on my right hand not itchy not red ) then at the end of the day it got worse spreading all over my arm and shoulder and left hand  Became itchy and kinda red specifically after scratching I called a Dermatologist who recommended Anti histamine ( Trade name Telfast) twice daily and Soothing gels, the Soothing gel made it less itchy that's it nothing worked it got worse and spread to my thigh and my leg and parts of my back, on my 4th day exactly about 6 am I vomited for about an hour continuously vomiting then I had Asthma attack I had my inhaler ( trade name ipravent) and I'm still sick
A report was received from a health care professional on 21Oct02, concerning a female vaccinee who was inadvertently administered last years batch of Fluvirin on 18Oct02. On 18Oct02, the vaccinee received 0.5ml Fluvirin IM. It was discovered later that it was last years batch. No adverse effects were reported at time of reporting. There was insufficient information to determine the reporter's causality assessment.  Ref: PJP200200677. Update 1 12Feb03: A report was received from a health care professional concerning a 46 year old vaccinee. The vaccinee was revaccinated with the 2003 vaccine (brand unspecified) on an unspecified date. The vaccinee experienced no adverse event at the time of the report.
The patient stated that she experienced severe discomfort and pain and had trouble utilizing her arm. She decided to consult with her physician. The doctor concluded there was nothing that could be done, it's possible the shot was given too high, but there was no conclusion other than just giving it time to heal.
Redness 6cm x 5cm in (R) deltoid area. No induration/blisters noted.
Per Mother after 10 minutes of having both shots, the child's left leg starting changing color (medium red). A small rash starting to form and went from 0.5 inches in length for area of injections to 5 1/4 inch from site of shot until mid ankle. Width is 1 inch wide. Site of injection was slightly warm but not hot. No other adverse events noted such as crying, lethargic, increased temp, temp remained at 98.6F axillary temp taken. Child was happy, playing and in good spirits, no s/sx of gi distress or respiratory concerns. O2 sat and respirations remained the same at intake.
High fever muscle pain ad sore red itchy arm. Today only arm symptom remains. This was my first shot. My fever broke overnight on the 11th to 12 th of February.
Information has been received from a nurse practitioner concerning a 6 week old white female infant who on 03Mar04 was vaccinated with a 0.5ml second dose of hep B virus vaccine rHBsAg (yeast) (lot 648251/1286N). There was no concomitant medication or illness at the time of vaccination. On 03Mar04 from 10:00PM to 3:00AM the pt cried inconsolably, also described as the mother was unable to console the infant. It was noted that the infant had no fever, no vomiting and no rash. It was noted that no medicine was given. Subsequently, the pt recovered on 04Mar04. There were no relevant diagnostic test or lab date. No further information is expected.
Nausea, vomiting, feels throat swelling, dizzy.  11/17/09 ER record received for DOS 10/29/09. DX: Allergic reaction (mild)  Pt c/o throat swelling, dizziness, nausea and vomiting; tx: Benadryl. Symptoms resolved.
The pt had her 1st HBV, 1 month ago at school. The next day she had a fever over 100F, swollen and sore throat, lymph glands swollen and chills. The 2nd HBV was given on 12/13/01. Mom states she had the same symptoms. Has had similar symptoms with strept infection but no fever in the past. Seen by a new doctor today.
Back pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (Back pain) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: elevated (High) Elevated. On an unknown date, Heart rate: elevated (High) Elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medical information were reported. No Treatment informations were reported.
Severe chills, weakness, aches, fever-onset about 1:00  AM; resolved by 6:00 AM 2/13/2021
A patient received improperly stored vaccine; This spontaneous report was received from an administrator and refers to an unknown number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with a dose of improperly stored vaccines: measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot S027467 exp. date:02-MAR-2020 (formulation, strength, dose, frequency and route of administration were not reported) as a prophylaxis. Administered dose of vaccine experienced the temperature excursion of 12.2 degrees Fahrenheit for 1 hour and 30 minutes. Data logger was involved. There was a previous excursion reported of 12.2 degrees Fahrenheit  for 1 hour.; Sender's Comments:  US-009507513-2011USA013430: US-009507513-2011USA013458:
pt recv vax 4DEC96 & 5DEC96 pt devel swelling in the arm @ the site of inj & flu-like sx including nausea, chills & body aches;
dizziness; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 22S3B, expiry date 25th March 2022) for prophylaxis.   On 13th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were reported as follows: The pharmacist asked for information on dizziness experienced after the patient received 1st dose of Shingrix. The reporter consent to follow up. No further information was provided.
I had the higher dose because I just turned 65.  I have never had a reaction to a flu shot before.  About 5 - 6 hours after getting it I had aches, fever, and chills for several hours.  It was better in the morning, but I felt ill occasionally for the next 2 days. I do not have a primary physician right now because I recently moved here.
Unconsolable crying, fever, red swollen injection site and surrounding area. Vomiting.
facial swelling, facial stinging, flushing approximately 45 minutes after vaccination. Persisted ~12 hours
PATIENT HAD A DUPLICATE MCIR AND WAS INOCULATED BEFORE THIS WAS DISCOVERED.  PATIENT MOTHER WAS NOTIFIED, STATED UNDERSTANDING AND PATIENT HAS HAD NO ADVERSE REACTION.
Right arm no longer can be lifted without pain or past shoulder height without difficulty.  Arm strength significantly compromised. Signs appeared shortly after second shot. Arm pain did not leave and lifting became difficult.  I was repeated told it was not the shot even though I told people it was.. No treatment or help was given.
Received the adjuvant component only; Received the adjuvant component only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 0729N, expiry date 31st May 2024) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix. On 23rd February 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's Comments: The pharmacist reported that earlier on the day of reporting, a patient was supposed to receive the first dose of Shingrix vaccine but received the adjuvant component only.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
74 year old male with a past medical history of CHF, CKD stage III, paroxysmal atrial fibrillation treated on Xarelto, hypertension, hyperlipidemia, history of alcohol abuse who presented to hospital postacute care with hypoxemia and worsening shortness of breath over the previous week.  He noticed a progression of the shortness of breath and subsequently developed cough without productive sputum.  Due to his worsening shortness of breath and cough he underwent PCR testing for COVID-19 was found to be positive.  He reports that he received 2 doses of the Pfizer Covid vaccine the last of which was 6 weeks ago. The patient had an extensive hospital stay that included acute decompensated heart failure, ARDS with COVID, intubation, cardiogenic shock, and AKI on CKD requiring CRRT. His family ultimately made the decision to transition to hospice care and the patient passed away 7/12/21.
Patient said he felt fine following injection but woke up in the middle of the night with severe pain radiating up his arm, with a hard lump at the injection site. He stated the area was warm to the touch and had red streaking. He said the pain persisted the next day and then resolved. I looked at the site on 5/10/18 and the area was not red or swollen.
On 09/20/2022I received my covid-19 vaccine. On 02/22/2023 I was experiencing flu like symptoms. After testing it was confirmed that I was positive for Covid-19 vaccine. After reaching out to your doctor I was prescribed Paxlovid. Symptoms lasted approx. 3  days.  however symptoms return with an sinus infection after it went away and lasted for another 3 days after taking Augmentin .
Vaccination Failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Oct2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Oct2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 28Oct2023 to 01Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300365986 Same patient, different product, different dose/event;
This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a infant patient who received ROTARIX (batch number A41CB390A, expiry date unknown). On an unknown date, the patient received ROTARIX. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: ROTARIX diluent was given without the powder. No adverse event reported. This case is one of the 3 cases reported by the same reporter for the same vaccine.
Patient stated that she had a bruise just below humorous bone and soreness from where shot was given. Being a nurse, she knew bruising and pain/tenderness at injection site was common after the flu shot. She gave it some time to improve but is still bother her. That is why she called it in on 11/25/19 at 11:20 am. She stated that she hasn't been to the doctor as of yet because it really hadn't been that bad. Sometimes she would experience numbness/tingling in right arm and fingers and when she lifts her arm from level with shoulder it would hurt. The morning of 11/25/19 it bothered her and she took some Tylenol for pain. She was wondering if she needed to file an incident report in case it got worse. She was worried maybe a nerve had been hit. As of 11/27 patient had started exercise she found online to help with numbness. She plans to wait to see how this does and if pain has not improved will go to doctor first of the year. Patient stated that if was already improving from where she couldn't put weight on it (she was referencing getting out of bed in the morning). Patient was given information about VICP and instructed to reach out to there first if she needed to go to the doctor.
After a few hrs (lft) arm began aching more than normal. Then it hurt so much that I couldn't lift it or move it. Or find a comfortable way to hold it. I had a very long sleepless nite with more pain (in the arm) than I've ever experienced (I live with chronic joint pain) it was off the charts. Today 3:45 pm 10/1/2014 I'm back to normal aches in arm (left).
In October of 2022, I was traveling on an airplane. I was feeling completely fine on the flight. In the airport I was starting to feel bad, then from the next flight I started to come down with chills and could not get warm. The next day I started to feel a headache come on, and feeling very uncomfortable. I had chills that continued and I never came down with a fever. On 10/28/2022 I took an at home COVID-19 test that came out positive. I tried to get in touch with my doctor however was unsuccessful. I was not short of breath or any lung issues. I contacted 911 to ask what I should do and I was then taken to the ER. I was given PAXLOVID and started it on the 29th of October. After that I was in bed for a very long time. I was isolated for about 5 days from my husband. Around six days I was starting to feel better and after 10 days I was back to normal. At this point my health is good and I am only having continuous hip pain from before.
sinus pressure; nausea; chills; arm soreness; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Jul2021 10:30 (Lot number: EW0169) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "N/A" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE; MEDROXYPROGESTERONE ACETATE. The following information was reported: PARANASAL SINUS DISCOMFORT (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "sinus pressure"; NAUSEA (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "nausea"; CHILLS (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "arm soreness"; FATIGUE (non-serious) with onset 08Jul2021 08:00, outcome "recovered", described as "tired". Therapeutic measures were not taken as a result of nausea, chills, pain in extremity, fatigue.  Additional Information: No other vaccine in four weeks. On 8Jul2021 - sinus pressure/nausea/chills/arm soreness 9Jul2021 - sinus pressure/nausea/chills/arm soreness 10Jul2021 - sinus pressure/arm soreness/tired 11Jul2021 - sinus pressure/arm soreness/tired. No covid prior vaccination. Covid was tested post vaccination.  Follow-up attempts are completed. No further information is expected.
No additional adverse effect reported.; the patient was inadvertently administered a dose of VARIVAX on 12/5/2019, that had been improperly stored.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). Information about pertinent medical history, drug reactions or allergies was not provided.   On 05-DEC-2019, the patient was inadvertently vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S021926, expiration date 15-JUL-2021; dosage detail, strength and route were not reported ) for prophylaxis. The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was properly stored. Administered doses of vaccine experienced temperature excursion of 1.2 degrees Celsius (C) for 3 hours 9 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Body aches, fatigue, headache, covid arm rash at injection site (hard, red and itchy).
Neurologic problems, brain fog, eye trouble. Had terrible sinus infection 2 wks after vaccine given. Took 2 antibiotics that wouldn't cure sinus infection. Being tested for liver problems. Still doing tests. Going to specialist.
Nausea and dizziness x 24 hours. Local inflammation x 72 hours. Local nodule x several days.