chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster dose of an expired vaccine; Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) to be not related. No further causality assessment was provided for ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose).    No concomitant and treatment medications were reported. The patient had no known allergies. There were no any other potential causes of the event. Vaccine was maintained in cold chain process for storage. Vaccine was pulled from the freezer inadvertently and administered to the patient in the form of a 0.25ml booster dose. The patient did not had any immediate issues.   This case was linked to MOD-2021-407228 (Patient Link).
Patient 12  years old  had Menveo administered at another facility on 9/10/2020.   Patient was seen for 12 year PE- the nurse and provider did not realize they received the vaccine,  and administered Menquadfi.   Patient has now received two Meningococcal vaccines in a two year time frame
Low grade fever at 100.6F, headache, fatigue, loss of appetite, diarrhea
temperature of 103.6/experiencing 101 F temperature or fever; not feeling well; cough; fatigue; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 28Mar2021 at 17:00, dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient was running 103.6 temperature. The patient stated she was not feeling well. The patient further stated that she was experiencing 101 Fahrenheit temperature or fever, cough, and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Second day arm soreness, mild symptoms of body aches,  syncope episode, taken to Er in another area . Only one time event . Then a week and  half later she started having 1-3 syncope episodes a day
day p/vax 18JAN95 began to cough;went to the MD & was treated for bronchitis;the cough cont even w/taking med prescribed by MD;further tests showed asthma;now taking med for asthma;
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. On 11-APR-2014, the patient was vaccinated with ZOSTAVAX (lot # H019092, expiration date: 09-FEB-2014). Dose, route of administration and anatomical location were not provided by the reporter. The pharmacist stated that, on 11-APR-2014 reported as today, a nurse administered an expired ZOSTAVAX to a patient. No adverse effects were reported. Additional information has been requested.
Subsequent to one dose of varicella virus vaccine live "a couple of years ago, the pt developed chickenpox in March, 2000 and sought unspecified medical attention. Additional information has been requested.
I broke out in hives all over my body and my  upper lip swelled. I was diagnosed with chronic hives and prescribed Prednisone, Allegra and Zyrtec to control.   In 09, I first broke out in hives, but it was due to an unknown source. I have had no troubles since.   After my first injection on 3/22/21, I did have minor hives in the same locations and no swelling in my face. I did not connect the dots until after my second dose.
a temperature of 101.7; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; the injection site was very swollen almost all the way around my arm; wispy breathing; This is a spontaneous report from a contactable consumer.   A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jul2021 13:30 (Batch/Lot Number: FA6780) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included ADHD and anxiety and known allergies: only to penicillin. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), quetiapine fumarate (SEROQUEL), buspirone hydrochloride (BUSPAR) and guanfacine all taken for an unspecified indication, start and stop date were not reported.  The patient stated, "the second day (08Jul2021) I had a pale/ blue appearance to my skin and shivering and had to take a hot shower to warm up.  Third day, the injection site was very swollen almost all the way around my arm and I have pictures and a temperature of 101.7, and wispy breathing. I had to call the nurse advise line for what to do and the nurse said to treat at home". Prior to vaccination, was the patient was not diagnosed with COVID-and not been tested for COVID-19. The patient received no treatment for the events. The outcome of the events was not recovered.
Shoulder still hurts one month after second moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder still hurts one month after second moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder still hurts one month after second moderna shot). At the time of the report, ARTHRALGIA (Shoulder still hurts one month after second moderna shot) outcome was unknown.            AE submitted through chatbot. shoulder still hurts one month after second moderna shot is that normal.   no concomitant medications were not reported.  treatment medications was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe Pain and swelling at the site of injection. Developed fever up to 103 F. Limping with pain. Thigh X-ray within normal limits. Symptoms lasted for 4 days and treated with Ice pack, Ibuprofen and Keflex for presumed cellulitis.
The day after getting the vaccine felt extreme fatigue that lasted 2 weeks.  No fever but altered activity level and felt thirsty all the time.  Had mono in the past and felt like she was having a reactivation of mono.
I had lower abdominal pain. I called my oncologist. It turned out to her Diverticulitis. Also had a fever. I also had diarrhea and a lot more abdominal pain.
Patient was administer a Moderna Covid vaccine with published expiry date 10/15/2021.  He was observed for 15 min after injection, tolerated injection well. No complications noted.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unknown number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. The causality of the event with (Oka/Merck) VARIVAX was not reported. This case is linked to #1502USA004417 via same reporter link. Additional information has been requested.
Within 12 hours had chill, nausea, headache, flu-like symptoms, extreme fatigue, this continued for about 24 hours. Woke up on Sunday April 4th with swollen arm at injection site that was red and hot. This went away after two days. Also have a light-headed or dizziness spell during the morning of Sunday April 4th. This lasted only about a half hour. Another light-headed/dizziness spell the following Sunday April 11th, again only briefly in the morning. This reoccured again on Sunday April 18th slightly longer, maybe about an hour or so that was accompanied by feeling of pressure in the ears and ringing sound. Then on Sunday April 25th felt light-headed/dizzy again in waves that come and go all day. Can last anywhere from 20 minute to hours. This sensation of feeling light-headed/dizzy/foggy continues April 25th through Saturday May 1st where the light-headed/dizzy feeling continues and now my ears started to feel really full and almost clogged. Ears continued to feel full and muffled, but I end up being super sensitive to sounds. I have ringing in my ears and specifically worse in the right ear. I still have full feeling ears and am almost continuously light-headed/dizzy (almost overmedicated feeling although I take no medication). This symptoms are consistent and do not see to be getting better since their onset of Sunday April 25th. They are interfering with my daily life and job.
Pt stated she is allergic to latex, but has gotten flu vaccine in previous years with no problems. Pt received vaccine at 4:25 pm. Pt complained of swelling, redness and warm to touch symptoms at 8:50 pm pt took BENADRYL which helped. Pt came to pharmacy the next day and symptoms were less severe. Pt took more BENADRYL and ibuprofen. Seems to be getting better so far.
Eliminated DPT from shots to see if there was a reaction and there was. 103 deg fever, screaming, unconsolable. Darkness, redness, swelling in inject site for 2 days.
1/21/2021- First Dose-  Following day mild muscle soreness at site, ongoing fatigue, never feels rested or wants/needs to sleep, a lot.  Noticed abdominal pain, but did not connect the two.  2/11/2021- 2nd dose- Two hours later (approx) moderate pain at site, my head/mind felt "off", out of sync like one side of brain slower,  affected balance. It was strange, and unpleasant.   2/12/2021- Groggy, face/eyes swollen, did not feel well, but not so bad I could not go to work. It was a 50 mile drive, and as I drove the same feeling of not thinking straight did not want to drive. The feeling of being unwell escalated quickly. Congestion, muscle aches throughout, sore throat, chills, and a need to catch my breath caused dizziness. I pulled over, called work, and made my way home where I went directly to bed. My head ached, abdominal (sharp) pains, especially after ingesting fluids. or food similar to gall bladder pain, but not close to its worse intensity still, continues.  2/15/2021- Update- Nearly 96 hrs. passed: What remains is:  Feeling exhausted, need to sleep, more frequent and intensifying abdominal pains, headaches, pain in left lung/easily winded, and site pain expansion. Injection arm (left) pins & needles, and fingers ice cold, neck pain (stiffness).
Sore arm; really bad nerve pain in the same arm where she got the shot.; In the same arm, in the armpit, she has an area that is really swollen and really tender.; In the same arm, in the armpit, she has an area that is really swollen and really tender.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), NEURALGIA (really bad nerve pain in the same arm where she got the shot.), VACCINATION SITE LYMPHADENOPATHY (In the same arm, in the armpit, she has an area that is really swollen and really tender.) and LYMPH NODE PAIN (In the same arm, in the armpit, she has an area that is really swollen and really tender.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm), NEURALGIA (really bad nerve pain in the same arm where she got the shot.), VACCINATION SITE LYMPHADENOPATHY (In the same arm, in the armpit, she has an area that is really swollen and really tender.) and LYMPH NODE PAIN (In the same arm, in the armpit, she has an area that is really swollen and really tender.). At the time of the report, VACCINATION SITE PAIN (Sore arm), NEURALGIA (really bad nerve pain in the same arm where she got the shot.), VACCINATION SITE LYMPHADENOPATHY (In the same arm, in the armpit, she has an area that is really swollen and really tender.) and LYMPH NODE PAIN (In the same arm, in the armpit, she has an area that is really swollen and really tender.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
This spontaneous report was received from a physician assistant currently 14 years old concerning a female patient with intermittent viral exanthum (rash) and drug reaction/allergies were not reported. The physician assistant reported that the patient received a dose of VARIVAX on 15-DEC-1998 as prophylaxis (dose, route and frequency were not reported). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that the patient experienced shingles at an unspecified date. The patient was not diagnosed or treated by the physician's practice. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Information has been received from a nurse (also reported as a healthcare worker) referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with (Oka/Merck) (dose, frequency were not reported). The reporter reported that 3 vials of (Oka/Merck) VARIVAX were completely shattered in the box (product container damaged). The 3 vials came in a package of 10. Due to this, the patient missed a dose. The patient did not seek for medical attention. Product quality complaint (PQC) was filed. No additional adverse event information was provided. Additional information has been requested.
A report was received from a consumer on 12/11/03 concerning a 56 year old female vaccinee who inadvertently received two doses of Fluvirin, one dose in the right arm and another in the left arm on 12/8/03. On 12/8/03, the vaccinee inadvertently received two doses of Fluvirin, one dose in the right arm and another in the left arm. At the time of the report, no adverse events had been reported. Follow up pending.
Member experienced chest pain over 18-19 Feb, was seen/treated in ER/admitted to cardiology. Discharge diagnoses: Pericarditis. Information added includes pain, PVC's. msv
It was reported that a patient (1 of 4) received a Fluzone SV vaccination on 11/30/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided.
Female patients presents with diaphoresis and dizziness immediately after being vaccinated with her Moderna booster dose.Patient was placed in trendelenburg position to maximize her venous return and normalize her blood pressure. Patient was left in observation area for 30 min, and vital signs were reevaluated and found to be WNL. Patient was discharged stable and with symptoms resolved.
Myalgia, Arthralgia, Fever, BURNING AND SWELLING AT THE INJECTION SITE, LOW BACK PAIN, BURNING SENSATION IN RIGHT GREAT TOE Narrative:
NauseaVomiting Narrative: Weakness from vomiting, could not get out of bed.
within 1 hour, started feeling tired and feverish, had fever, headache, and tired, no energy
Pt given 3 doses of RecombivaxHB  12hrs following 3rd developed pruritic hives; Also maculopapular rash w/hives; stiff neck, proximal rt lower extremity weakness, acute inflam polyneuropathy;
low grade fever of 100; tired; headache; sore right arm and right shoulder; This is a spontaneous report from a contactable consumer (Patient). A 45-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) ) via an unspecified route of administration in arm right on 23Feb2021 13:00 (age at vaccination 45 -years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included omeprazole (PRILOSEC) taken for an unspecified indication. The patient previously received first single dose of bnt162b2 on 03feb2021 09:30 AM at right arm as single for Covid-19 immunization (Lot number: EL3247,). On 24Feb2021 05:00 the patient experienced low grade fever of 100 , tired , headache, sore right arm and right shoulder. The events were considered as non serious by the reporter. On 24Feb2021 the patient body temperature was 100.No treatment was given for the events. Patient did not receive any other vaccines within 4 weeks, prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
8/18/21: Experienced eye strain immediately after the vaccine, but then that subsided.  Has since had generalized whole body joint pain and relentless fatigue.
Itchy red rash in blotches on lower back and legs. Lasted off & on for 3 days. BENADRYL given.
Veteran received the first dose on 6/15/2021 and the 2nd on 07/13/2021 .  He presented to the ED on 07/26/2021 with shortness of breath X 1 month.   He was diagnosed with multiple bilateral pulmonary emboli.
Within 30 minutes of vaccine patient's left pupil was dilated greater than right and reacted sluggishly to light with slight fuzzy vision.  No other signs or symptoms.    Pt to follow-up with Ophthalmologist next week.
SUSPECTED COVID-19 INFECTION; SWEATING; LACK OF APPETITE; BITTER TASTE; ENHANCED TASTE; SLEEPLESSNESS; LIGHTHEADEDNESS; STOMACH REJECTED IT THREW UP IN A FEW MINUTES; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, anorexia nervosa, osteoporosis, osteoarthritis, and allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number, and expiry were not reported) 1 in total, dose was not reported administered on 05-MAY-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number, and expiry were not reported) 1 in total, dose was not reported administered on 08-DEC-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The batch number was not reported and has been requested. The patient additionally received non-company suspect vaccine included: Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 3) (Form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered on 25-MAY-2022 for covid-19 prophylaxis. Concomitant medications included alendronate sodium, citalopram, terbinafine, and trazodone.  On an unspecified date, the patient experienced covid-19 infection (coded as suspected covid-19 infection) (dose number in series 3). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration not reported, batch number: FX8133, and expiry: UNKNOWN) dose was not reported, administered from 06-JUL-2022 to 10-JUL-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. On 07-JUL-2022, the patient experienced sweating, lack of appetite, bitter taste, enhanced taste, sleeplessness, and lightheadedness (dose number in series 3). When the patient started the fifth dose her stomach rejected it. The patient threw up in a few minutes, her doctor told her to stop taking Trazadone during the treatment since it was on the list of drugs that conflict with Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, Pfizer BioNtech covid-19 vaccine (tozinameran) was not applicable and with paxlovid was drug discontinued. The patient recovered from sweating, lack of appetite, bitter taste, enhanced taste, sleeplessness, lightheadedness, and stomach rejected it threw up in a few minutes on 10-JUL-2022, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
FLU LIKE SYMPTOMS; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) and PYREXIA (FEVER) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) and PYREXIA (FEVER). At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided. No treatment drugs were provided. Patient received COVID Vaccine about three weeks ago.
Left Vaccine site, nose immediately got congested and couldn't breathe out of my nose. My body was itchy all day. I was putting my baby girl to sleep and my body felt like it was on fire. After she fell asleep, I went into the bathroom and had hives all over my body. My ears started to turn purple and throat swelled up. It became hard for me to breathe which is when I rushed to the ER and was diagnosed with Anaphylaxis. I was given an epi pen and steroid prescription for the following 3 days.