chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd Hep B vax on 21MAY92; pt devel flu-like illness characterized by hot flashes, achiness, tiredness & a h/a;
Developed Severe pain in left hip and thigh rain down the leg that started shortly after getting the vaccine. The pain lasted approximately 48 hours.
feeling a little flushed around the face; headache; tired; Chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (feeling a little flushed around the face), FATIGUE (tired), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (tired), CHILLS (Chills) and MYALGIA (Muscle aches). On 11-Feb-2021, the patient experienced FLUSHING (feeling a little flushed around the face) and HEADACHE (headache). At the time of the report, FLUSHING (feeling a little flushed around the face), FATIGUE (tired), CHILLS (Chills), MYALGIA (Muscle aches) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Following injection, pt c/o dizziness, blurred vision. LOC <15 seconds. Pt pale. Lungs clear.
In early March of 2023, I had a cough and a runny nose, a headache. I got over that. I then went out of town and came back and got sick again with the same symptoms. The cough got worse. I went to the doctor who thought I got 2 bugs, one right after the other. He gave me an antibiotic and some cough medicine. It took around 4 or 5 days and then it was over.
Patient has a prior history of Guillan Barre Syndrome. After administration of her booster dose of the Pfizer COVID-19 vaccine, she reported onset of symptoms consistent with her previous Guillan Barre symptoms, including weakness in lower limbs, "tingling" sensation in lower limbs, and described them as "rubbery".  She reports these symptoms resolved in 7-10 days, and did not seek medical care during that period.
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 03-DEC-2012, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot number were not provided). The vaccine did not prevent shingles as intended (vaccination failure) and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-AUG-2015, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient suffered and would continue suffering significant medical expenses, pain, suffering (emotional distress) and other damages on unspecified dates. The final outcome of the events was not specified. Vaccination failure, emotional distress, painful injury, damages, and herpes zoster were considered to be related to ZOSTAVAX.
allergic reaction; her face was itchy; swollen tongue; This is a spontaneous report from a contactable consumer (sister-in-law) via Medical Information Team. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021, the patient experienced allergic reaction and described it as "her face was itchy and has a swollen tongue." The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of all events which includes Benadryl. The patient was recovering from all events.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
My daughter has developed a rash on her stocking; having high fever; This is a spontaneous report from a contactable consumer or other non-HCP (patient mother). A 15-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration in left arm on 08Jun2021 at 15:00 as dose 2, single (at the age of: 15-year-old) for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration dates were not reported), via unspecified route of administration in right arm. Medical history included migraine and asthma. The patient's concomitant medications were not reported. No other vaccine administered in last four weeks. The patient had diagnosed with COVID prior vaccination and not diagnosed post vaccination, patient had not tested with COVID. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 10Jun2021 at 15:00 The patient experienced she has developed a rash on her stocking and having high fever. Therapeutic measures were taken as Tylenol and benadryl as a result of she has developed a rash on her stocking, having high fever. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The outcome of all event was not recovered.  Follow up attempts are needed, Information on lot/batch number has been requested.
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 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Athsma" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN, start date: 14Jan2023, stop date: 20Jan2023; GUAIFENESIN taken for cough, start date: 14Jan2023, stop date: 20Jan2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13Jan2023 and stopped on 19Jan2023.  Clinical course was reported as, Paxlovid side effects metal taste in mouth, drowsiness, Diarrhoea, Gas, dry mouth on 15Jan2023. Patient not recovered from symptoms. Patient did not get treatment for AE.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a Nurse refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On 22-AUG-2017, the patient was vaccinated with GARDASIL 9, (lot # N021571, Exp date: 29-APR-2020), dose 1, 1 DF, intramuscularly for prophylaxis. On 19-FEB-2018, the patient was vaccinated with second dose of GARDASIL 9, (lot # N021571, Exp date: 29-APR-2020), 1 dosage form (DF), intramuscularly for prophylaxis (Drug administration interval too long). It was reported that the second dose was received three days too early. No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was present.
This case was reported by a consumer via call center representative and described the occurrence of vaccine exposure via breast milk in a unk infant. The parent received the product. Concurrent medical conditions included breastfeeding. On an unknown date, the mother received FLULAVAL at an unknown dose. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with vaccine exposure via breast milk. On an unknown date, the outcome of the vaccine exposure via breast milk was unknown. It was unknown if the reporter considered the vaccine exposure via breast milk to be related to FLULAVAL. Additional information received: Mother of baby called and said she received a flu vaccine and she is currently nursing. She does not know which Flu vaccine she received, however she knows it was a GSK flu vaccine, it had preservatives in it, and it came from a multi-dose vial. She did not want to do the AE form.
Covid vaccine was administered past the 10  week beyond use date of 07/05/23 - no adverse events reported
Itchiness in various parts of my body.  No rash; no hives; no redness.  Started 18 hours after the vaccine
It started the morning after his shots on his left thigh with a 4-5 inch red, itchy circumference that had a fever of 104. The infection site was very large and extremely hard. His body temp. reached 101. By that evening his entire leg was swollen and red. Still with a fever of 104. He became very lethargic, slurring his words, and had a really hard time keeping his eyes open. He complained of pain all over his body and terrible stomach pains. He has been very aggressive and defiant since. He is acting like a completely different child. He has been violent and having temper tantrums, which is not him at all.
First my son complained his arm that the shot was in was really hurting, he couldn't lay on it in bed. Then when he awoke the following day his arm was very swollen, red, a tiny bubble was where the shot went in and it was extremely hot to touch. The following day we went back to dr b/c it was still very red & hurt etc. Our dr put him on antibiotics in case of infection, she didn't like how hot & red it was.
The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023; No adverse event; Primary series vaccines Expired on 02/28/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023), PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 083822A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023), PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023) and PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023).    No concomitant medication were reported.  The vaccines expired on 28-FEB-2023 but was not delivered to pharmacy until 07-MAR-2023 and 3 patients were administered this vaccine on 17-MAR-2023 and no side effects were reported. Vial size was 5.5 mL. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716139, US-MODERNATX, INC.-MOD-2023-716329 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716139: US-MODERNATX, INC.-MOD-2023-716329:same reporter
Swelling area administered with redness - progressed to cough and wheezing and SOB.
Severe lower back pain; It hurts to walk; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 22Apr2021 at 14:15 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 08:00, the patient experienced severe lower back pain and it hurt to walk. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe lower back pain and it hurt to walk was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # M034780 with expiration date 15-APR-2019 and lot # M036509 with expiration date 03-JUN-2019 (dose and route of administration not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 30 minutes. Digital data logger was used to record the excursion. The vaccine already underwent previous excursion of 32 to 35 degrees Fahrenheit for 185 hours and 45 minutes. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010519: US-009507513-1704USA010520:
Patient vaccinated with Pfizer COVID vaccine 1/27/21 and 2/17/21, developed weakness on 10/8 and presented to reporting hospital 10/14/21 with fatigue, muscle weakness, cough, body aches, denied SoB. Patient tested positive for COVID via COVID PCR admission screen administered via NP, taken 10/14 and resulted 10/14. Patient admitted for observation, started on oral dexamethasone. Discharged 10/15/21 after feeling closer to baseline.
RN DREW UP ENTIRE VIAL OF PFIZER VACCINE WITHOUT ADDING DILUENT AND MA ADMINISTERED TO THE PATIENT. PATIENT ABRUPTLY LEFT PRACTICE AFTER THE ERROR WAS DISCLOSED.  WE HAVE NOT BEEN ABLE TO CONTACT THE PATIENT.
Pt experienced full-blown Tourettes event which is continuing at the time of this report. he had not had a serious event since he had his DTaP booster in 3/03. in retrospect his mother reports that the very first event was following his 18mo booster.
pt became flush nauseated increased anxiety  increased hypertension short lived  no hivea no swelling
HAD INTERMITTENT LOW GRADE TEMP (99-100 DEGREES)FOR 5-7 DAYS ACCORDING TO THE MOTHER.  WAS FUSSY AND SLEEPING MORE THAN NORMAL. CALLED FOR ADVISE ON 7/27/05.  WAS ADVISED TO CONTINUE TYLENOL & MONITOR S/S. CALL BACK IF WORSENED OR PERSISTED.
c/o itchy rash starting 1/2 which worsened after getting covid vaccine 1/7/21, was seen in Urgent care on 1/10//21 and given prednisone, had f/u in Urgent Care 1/19/21 for recurrent rash after DC finish prednisone, treatment repeated.
Patient with mild erythematous. Maculopapular rash just medial to injection site next day. No fever. No difficulty breathing. Injection site ok.
Swelling & redness from elbow up; MD ordered cold compresses & DPH;
Chills; body aches; slight headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269), via an unspecified route of administration on Feb2021 as dose number unknown, single for covid-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. The patient did not have any known allergies. Concomitant medications included drospirenone, ethinylestradiol (SYEDA), orally for contraception; montelukast. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 10Feb2021 at 12:00, 19 hours after injection patient experienced chills, body aches, slight headache. The patient did not received treatment due to the events. The outcome of events was recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
patient had asked to get moderna vaccine. A drawn up Janssen vaccination was provided to nurse to administer by myself. The error was figured out and the patient contact was attempted to update them.
very fussy-inconsolable crying, immed x 3 days;3 days p/vax had first sz-taken to hosp;fever began 1hr p/vax;sent home from hosp returned to hosp x 3 days for sz increasing in frequency;no tx no dx;devel delayed;
As the vaccine was being administered, I felt a heat sensation in my arm and in my chest.  After sitting for 20 minutes, my tongue began to tingle and the pharmacist asked if I was alright, I told him I didn't know and got up and described my symptons.  He advised me to take Benadryl, which I did, I took 1/2 of a Kids Benadryl and the feeling subsided about 30 minutes later.  I continued to take Benadryl every 6 hours for a period of 24 hours.  I felt better and stopped taking the Benadryl.  ( I was also extremely tired after the vaccine)  I stopped taking the Benadryl at noon on March 15th and felt better.  I woke up at 4:30 a.m. on March 16th with that same heat sensation but only in my lower arms, from my elbow to my wrist.  I again took Benadryl and it went away.  The morning of March 29th, I woke up at 4:30 a.m. with the same feeling in my lower arms.  I again took Benadryl and it went away, only to return at 4:30 A.M. on March 30th.  I took Benadryl, but have been experiencing that same sensation all day.
patient was sitting in chair, said she wasn't feeling well, she slumped in the chair and fainted. We laid her on the floor and she started breathing normally and sat back up. She got back up and sat in the chair for about 5 minutes and said she was nauseous and felt really warm, she vomited in the trash can and said she felt better. We had he wait for another 10 minutes and her friend came to pick her up. When she left her color was good and she said she felt okay.
Chills, arm soar, left arm pit is soar and swollen  going on 4 days
Every time patient get the shot get sick; had covid 19; Initial information was received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer (patient). This case involved an unknown age patient who reported that every time patient get the shot get sick (Illness) and had COVID-19 (corona virus disease), while being received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received INFLUENZA VACCINE (unknown manufacturer) (batch number and dosing details were unknown) for prophylactic vaccination.  On an unknown date (unknown latency) after the administration of INFLUENZA VACCINE, it was reported that every time patient get the shot get sick (Illness) and had COVID-19.  Laboratory test included Covid-19 test.  Corrective treatment included hydrog, A-Z pac, Zinc and Vitamin D 3.  Batch number will not be available for this case.
Rash eczema/psoriasis behind left knee and by right knee. Knee pain including significant swelling behind left knee which has resolved. Rash behind left knee resolved but right knee rash (burning/itching) has persisted but improved and using topical steroid. Severe diffuse  headache, difficulty concentrating,  slow performance, tachycardia to 120's mainly and some shortness of breath and left sided chest pressure for 48 hours along with fatigue. June 01, had tinnitus for a day. June 07, general intense feeling of not feeling well and headache. June 15, developed severe left leg pain and malaise. June 23, 8-9/10 pain behind left thigh and difficulty walking. Later developed exacerbation of prior mild right knee pain of recent onset to point could not walk.
On 3/4/2021 I felt heart racing and use the pulse oximeter which show heart rate 140-150 and saturation 94%.  I called my doctor office and was told to go to the hospital.
Patient given the 2nd dose of COVID-19 vaccine only 16 days after the initial dose given. No known symptoms or reactions.
Information has been received from a physician concerning a 42 month old male who on 25-SEP-2007 was vaccinated with a dose of MMR II(route, site, and lot number not reported). On 22-NOV-2009 the patient experienced mumps (the date diagnosed was reported as 15-NOV-2009). The patient had no fever. On 16-NOV-2009, the first blood work was done which revealed serum IgM <1:10, serum IgG 8.26 and serum amylase 618. The outcome for mumps was not reported. Follow up information has been received and indicated that the 39 month old male patient (previously reported as 42 month old) was vaccinated with his first dose of MMR II (route, site, and lot number not reported) on 25-SEP-2007. On 02-DEC-2009 the patient experienced mumps, diagnosed was made on 03-DEC-2009. The patient had right parotitis, pain under Rt ear and diarrhea. Diagnostic laboratory tests performed on 03-DEC-2009 included: IgM: 0.23; IgG: 3.63 and serum amylase: 34. This is one of several reports from the same source. No further information is available.
Fatigue after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after second dose) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after second dose). At the time of the report, FATIGUE (Fatigue after second dose) outcome was unknown.
Pt immediately had a headache after the vaccine and this progressed to neck  pain/spasm and severe fatigue