chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 hours after vaccine. Daughter complained about sore joints in legs and elbows, back of neck pain and was crying in pain and had a fever of 101.  Loss of appetite, and low energy. We administered Tylenol around 6:30pm.   At 11:30 pm child woke up screaming in pain like we've never heard her scream before.  She had a fever of 104.7,  was complaining of abdominal pain, and holding herself in the fetal position, was unable to hold her urine. She vomited twice. We administered Tylenol and called the after hour nurse. We were told to take her to the ER if she hit 105. Through out the night she was in a lot of pain. I took her to the Urgent Care around 7-8am. They checked her for appendicitis and UTI and wanted us to follow up with her Internist when they opened.  We checked back with primary care doctor around 11am. My daughters fever had gone down at the time and she was feeling better.  She developed a rash on her back and neck (maybe from the high fever). 2 weeks later on December 24th my daughter lost all ability to hold her urine. She went from not having accidents day or night, to wetting uncontrollably. We went to urgent care where UTI was checked again nothing. After 2 weeks she gained some bladder control but still wets the bed at night and has occasional accidents. We've also seen a neurologist who prescribed a MRI of  her brain and spinal cord and ruled out anything involved there. I believe the vaccine /subsequent fever  triggered her loss of bladder control.
Mother states that she experience vomiting overnight after the shot.  She also developed hives the next day with shortness of breath.  Mom states she used Benadryl the 1st, 2nd and 3rd of April along with having to use an albuterol inhaler those days as well.  She had a vomiting episode on Saturday the 3rd as well.  Sunday the 4th, she was having no symptoms as previously reported and is currently asymptomatic.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2 NOS), on 22Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as treatment drug from 28Apr2023 to 02May2023.  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 current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product Comirnaty cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300182911 same patient/reporter; different drug/AE;
Immediately post injection slight swelling and soreness about 1 inch around site that resolved completely within a couple days.  No other reaction.  1 week post injection area around injection site that was 4-6 inches wide. Approximately half the circumference of the arm was hot, red, hard and swollen.  It was moderately painful and itched significantly.  Lasted about 3 days and has been slowly resolving (not as red, not or swollen)-still (5 days later) area about 4 inch in diameter that is red, but not as swollen/painful/itchy.  Reporting because seemed weird that reaction started a week later.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 29-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 29-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Patient was inadvertently given 2ml of the 0.3ml recommended dose of this vaccine.  Only reactions that were reported over a 3 day post event were injection site soreness and slight headache.
Generalized rash occurred approximately 2 hours after receiving Moderna vaccine.  Complaints of headache and mouth discomfort.
This patient received her first dose on June 30, 2021. She is a healthcare worker at a long term care facility. The administrator was notified that the on-site clinic would be held at the facility on 07/14/2021, and the administrator told the employee to appear that day for the second shot. The screening form was completed after the time vaccination was given. It was during that time that it was noted that the first dose had transpired 2 weeks, not 4 weeks, prior to the second being given. Patient was asymptomatic and monitored for the required time. Notified her that CDC would be contacted via VAERS and we would advise her accordingly. CDC was contacted via phone this day and CDC technician reported that patient was considered "fully vaccinated" and reminded this writer to complete the VAERS.
2-month-old has been given half the dose of the blue lid of pentacel, green lid has not been administered with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who had been given half the dose of the blue lid of pentacel, green lid has not been administered with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection via unknown route in unknown administration site for prophylactic vaccination (strength, dose, batch number and expiry date: unknown), 2-month-old had been given half the dose of the blue lid of pentacel, green lid has not been administered with no reported adverse event (Single component of a two-component product administered) (latency same day).  Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event Single component of a two-component product administered.  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 the guidelines. 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.
I contracted COVID-19 a couple of days after receiving my vaccine; I took an at-home COVID-19 on 01/11/2023 which came back negative. I knew something was wrong, so I took another test on 01/14/2023 which rightfully came back positive. I had coughing, sneezing, itchy eyes, scratchy throat, runny nose, and difficulty breathing from coughing. I contacted my doctor who prescribed me anti-viral LAGEVRIO to help with my symptoms. As of now, I'm improving everyday getting better with a cough still at times.
Within 4 hours: Difficulty breathing; A fast heartbeat; and Numbness and tingling.
patient started experiencing swelling in the face and arm, arm is red, hot to the touch just below the injection site
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus anticoagulant (w/o lupus)" (unspecified if ongoing); "Lupus anticoagulant (w/o lupus)" (unspecified if ongoing). There were no concomitant medications within 2 weeks. Past drug history included: Benadryl, reaction(s): "Known allergies: Benadryl". The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300080882 Same patient, different product and event;
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) had resolved. 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. Concomitant medications was not provided by the reporter. Treatment information was not provided. The vaccine had been placed in the refrigerator from the Freezer on 12-Jul-2021, and thus it had  expired on 11-Aug-2021. 5 patients were vaccinated with expired vaccine, first patient on 24-Aug-2021, second on 26-Aug-2021 and last 3 patients were on 27-Aug-2021.
The pt woke up with a very itchy neck. Said he couldn't sleep because of neck itching. Mother said neck was red and swollen. When mother called to check him he complained of itchy legs. The pt stayed home with his father.
A team of three pharmacist went to round on the floor to immunize residents. They were being accompanied by a nurse The patients consent forms were organized in order of room number related to the wing, on top of the consent forms was a census list (room list of all the patients on the floor).  Per my understanding, at approximately 11:30, the team went to the floor to begin immunizing patients. At approximately 11:45 the incident occurred. A patient of the facility, 6/9/34 mistakenly received the vaccine. There was confusion regarding the floor list and both pharmacists believed that both patients in the room needed to be vaccinated; however, the consent forms were not double checked. By the time the mistake was identified, the vaccine had already been administered. The daughter of the patient was promptly notified. The administrator of the facility first spoke to her, then she discussed the situation with the physician of the facility and finally I also spoke to her to apologize and alleviate any concerns. When I finished the conversation the daughter was still very upset that the incident occurred and did not consent to the vaccination, however, she did accept my apology.
Within 24 hours after injection, pt experienced, "runny nose", productive cough, muscle ache, dizziness, loss of appetite.
Shaking chills, body aches, nausea, headache followed by fever and exhaustion.  Improved in 12 hrs.  Returned to normal in 24 hrs.  All normal side effects but more intense than anticipated.
Local rxn to DTP vax dx by hosp 5 hrs post inject (lt arm); swelling from shoulder to fingers; MD prescribed Advil for any fever if occurred;
10 hours after injection: Cold, Fever, body aches and pain in joints, muscles,, head.    Lasted 24 hours
No pain at site of injection. (A) Onset around 8:00 pm on day of injection: chills, shaking, fever (no thermometer was available -- legs, stomach and head were very hot to the touch for about an hour, despite strong chills); strong migraine; sensitivity to light, sound, touch; mild body aches. (B) Menstrual cycle began on time about 2 days after injection, but persisted for 3 days longer than usual. Normal bleeding occurs over 2.5 days, but light bleeding occurred much longer than any time in the previous decade. TREATMENT: (A) Tylenol, warm blankets, heat pad; (B) Ibuprofen 400mg, heat pad (normal treatment)
stabbing, throbbing pain in and around my left ear; This was my 3rd shot; This was my 3rd shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient).  A 38-years-old non pregnant female received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was FC3180) via an unspecified route of administration, administered in right arm on 02Sep2021 at 13:45, administered in right arm (age at the time of vaccination was 38-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization (off label use). The patient's medical history included Psoriatic Arthritis, Anxiety, Sinus Tachycardia, Asthma. The concomitant medications included Humira (ADA-LIMUMAB), Sulfasalazine, Tizanidine, Alprazonam and Zyrtec allergy (CETIRIZINE HYDROCHLORIDE) for an unspecified indication, within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. The patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. Previously, the patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization; and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On 02Sep2021, the patient experienced stabbing, throbbing pain in and around left ear (reported as: stabbing, throbbing pain in and around my left ear). No treatment was received for adverse events. The clinical outcome of the events stabbing, throbbing pain in and around left ear was recovering.  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-JAN-2013, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, the patient was treated by a Doctor of Osteopathic Medicine (D.O.) for the onset of a severe vesicular rash, 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 had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
No adverse effects reported; the patient was administered an expired dose of MMR II; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2019, the patient was administered an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) 0.5 milliliter subcutaneously (lot # N026828, expiry date 27-SEP-2019) for prophylaxis. No adverse effects were reported.  The outcome of the event was unknown.
Patient recieved a Prevnar 20 instead of Prevanr 13, no adverse symptoms after injection
MIGRAINE HEADACHE, FEVER OF 103, CONGESTION, LINGERING COUGH LASTING 6 WEEKS.
MD called 10 minutes from administration of vaccine due to redness and itching at the injection site. At 11:10AM Pt. started to complain of right side of throat feeling "weird", cough and generalized itchiness (rash) 11:20AM: VS: 134/90, HR 89, RR, 18 and regular, O2 Sat 100% RA. MD came to vaccine clinic and administered 25mg Benadryl PO. Pt. ambulated to ED for further evaluation.
Information has been received from a nurse practitioner concerning a male patient with a history of drug addiction who on 6/25/03 was vaccinated with a dose of hepatitis A virus vaccine inactivated. Three days post vaccination on 6/28/03, the patient developed a generalized rash. Unspecified medical attention was sought, but the patient was not hospitalized. At the time of the report, the patient was fine and it was noted that he recovered. A product quality complaint was not involved. Additional information has been requested.
Patient called the pharmacy stating her right arm was red, swollen and sore around the injection site. I referred her to be seen by a physician in the case that it was cellulitis. Patient was seen in the ER with dx of cellulitis and given a 7 day course of doxycycline.
pt recvd vax 17JUL95 & 10NOV95 pt exp a raised, hive-like rash on trunk, which was painless & pt did not exp a fever;pt was seen by MD on 11NOV95 & rash progressed t open, painful vesicles;dx rash w/lesions as shingles
Over a 4hour span on 3/29/17 became acutely hypotonic, with poor suck and lethargy. Admitted to PICU 3/30, Intubated 4/1 for respiratory failure, ruled out botulism and eventually diagnosed with GBS on 4/5 after repeat LP showed 0 RBC, 2 WBC, and >200 protein. Slowly improving with IVIG slated to run a 5 day course (4/5-4/9). Remains hospitalized and intubated (currently day 9 of hospitalization), and anticipate weeks to months more of hospitalization.
Broke out in shingles; Itching; Irritation; Blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles year ago and aware of the appearances and feeling itching, difficulty wearing clothes) and pruritus.   On 15th June 2020, the patient received the 2nd dose of Shingrix. On 16th June 2020, 1 days after receiving Shingrix, the patient experienced shingles, pruritus, skin irritation and blister. On an unknown date, the outcome of the shingles, pruritus, skin irritation and blister were recovered/resolved.   It was unknown if the reporter considered the shingles, pruritus, skin irritation and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and broke out in shingles and they are still bothering me and reported several times to the VA and took pictures of the breakout.  The reporter stated his condition was minor but subsiding, itching and irritation. The patient was breaking out, there are no new blisters.  The reporter stated he had spoken to his healthcare provider but she had not seen them. He states that, because of fact that they are not all in same vicinity, his HCP doubts it was shingles. The reporter consented to follow up. No additional details were available.  Attempted callback but had to leave voicemail message.  The customer called back while filling out AE report and was patient not HCP.   HCP information for his HCP was provided in form.
lymph nodes on both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes on both arms are swollen) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic leukemia.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes on both arms are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes on both arms are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included an unspecified infusion for chronic leukemia.  Patient's lymph nodes on both arms were swollen about a week after vaccination. She did not took any treatment for the event.
pt recv vax & devel a poison-ivy like rash, redness, soreness & discomfort in upper arm;