chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling bad; flulike symptoms such as nausea; 99.5F temperature; he had pain in the lower back; muscular cramps; muscle and joint aches; A spontaneous report  was received from a consumer concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feeling bad, he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) feeling bad. he had pain in the lower back, tight very bad muscular cramps in his back, arm, and legs, flulike symptoms such as nausea, 99.5f temperature, muscle and joint aches.  Treatment details included He took 5-6 tablets of extra strength Tylenol.  Action taken with mRNA-1273 in response to the events were not applicable.   The outcome of event(s), feeling bad, he had pain in the lower back,tight very bad muscular cramps in his back,arm,and legs,flulike symptoms such as nausea,99,5f temperature,muscle and joint aches was unknown.
No additional AE's; A medical assistant called to report a temperature excursion involving administered PROQUAD vaccines; This spontaneous report has been received from medical assistant referring to a patient of unreported age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 21-DEC-2021, the patient was vaccinated with  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot number#: U022726. expiration date: 16-JAN-2023) (dose, vaccination scheme, frequency, route of administration and anatomical site of vaccination were not reported) for prophylaxis which was involved in temperature excursion. (Product storage error)  No additional adverse events reported.
(Fever of 103 next day) 36 hours later my son had a seizure-like reaction - he was staring, unresponsive and his right arm and leg were jerking. The unresponsive behavior lasted about 3 minutes and the jerking limbs lasted about 30 secs. An hour later in the ER, his temperature spiked to 105.8 and it had been normal. His temperature prior to the seizure was normal.  4/8/08 Reviewed hospital medical records for 2/15-2/16/2008. FINAL DX: Febrile seizure. Records reveal patient experienced fever max 103.5 x 2 days s/p vaccinations.  Parents reported staring spell x 4 min twitching right extremities w/no postictal period.  Seen in outlying ER where temp 105.8.  Tx w/IV antibiotics & transferred to higher level of care.  Neuro consult done.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 23-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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. The reporter stated that because their facility has not been able to download the digital data logger, they have been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the State was made.  There had been no power outages that would have impacted the Moderna vaccine. However, she reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion.  Reporter stated that no adverse reactions were reported by any patients.
Approximately 20 minutes after receiving vaccine, "face was twisting, drooling and was unable to talk" according to child's mother (who was called by front office staff at school). Child was taken to ER and received Benadryl injection, was discharged and returned to school the next day.
On the 2nd day after injection (Sept 7th) the lymph nodes located in the area of the left armpit were swollen and remained so for 5 days.  Currently, the swelling is gone.  In addition, on September 7th and continuing as of today the 11th, I have had mild but persistent headaches, nausea, and intermittent diarrhea.
This report is about the second vaccination I received yesterday on 9-11-2021. I had extreme insomnia. I did not sleep AT ALL, all night and have not been able to sleep at all throughout the day (no naps). I did some on-line research and found this was a (possibly rare) side-effect for quite a few people. One person said that she has not slept for 3 weeks after her second vaccine. I take pharmaceutical-strength medications for insomnia. They work perfectly well EXCEPT they didn't work at all last night.  I'm truly alarmed at this development. I would like you to add this to your symptom checklist, because it's serious.  Try working or driving on no sleep for a few days.
3 days after receiving the first dose, I began having diarrhea which continued for 7 days. I also experienced nausea and extreme fatigue during this time. I was admitted to the ER on 7/1/21 and was diagnosed with diarrhea with unknown cause. I also experienced extreme malaise including nausea, headache, and fatigue for the majority of the next 3 weeks after my first vaccine. After I received my 2nd dose on 7/12/2021, I experienced a swollen lymph node in my right armpit beginning on 7/13 and dissipating after one day. 5 days after my 2nd dose, on 7/18/2021, I began experiencing paresthesia in my right arm and hand, which has continued for 2 more days and has now spread to my right thigh. 6 days after the 2nd dose I experienced extreme malaise, nausea and a headache. I am now 7 days out from my 2nd vaccine and still experiencing these symptoms. I am very concerned about the neuropathic response I am experiencing.
Nasal Swab: Positive; This is a spontaneous report received from a contactable consumer (Patient). A 50-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Jan2021 as single dose for covid-19 immunisation. Medical history included polycythaemia vera, food allergy and environmental allergy. Concomitant medications included probiotics and multivitamins (in two weeks). The patient previously took antihistamines and experienced antihistamines allergy, steroids and experienced steroids allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 21Jan2021, the patient experienced nasal swab: positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 21Jan2021. The event resulted into doctor or other healthcare professional office/clinic visit (seeing allergist) and emergency room/department or urgent care visit. The outcome of event was not recovered/not resolved.   Follow-Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 10-JUL-2015 the patient was vaccinated with one dose of improperly stored GARDASIL (dose and route of vaccination were not reported, lot# reported as L004741 with exp. date 04-MAR-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hemmoragic Stroke. Began with vision difficulty in the morning. Then I noticed she had left sided neglect. Went to ER. Treated with Andresxa (to counteract Elaquis). In SICU for 2 nights then telemetry unit for 3 nights.  CUrrently in Rehab.
1 week after administration of MMR developed headache, chills, low grade fever, nausea, and cellulitis to injection site.  Treated with Keflex Clindamycin.
Information has been received from a certified medical assistant concerning a 11 year old female with seizure activity, temporal lobe lesion (is taking topiramate), no history of drug reactions/allergies, and a history of headache and migraine who on 18-MAR-2008 was vaccinated with a first dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM In the left deltoid. Concomitant therapy also given on 18-MAR-2008 included MENACTRA, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Other concomitant therapy included TOPAMAX. On 19-MAR-2008, the day after the first dose of GARDASIL, the patient experienced seizure activity at school, but it was not reported to the doctor's office at that time. On 19-MAY-2008, the patient was vaccinated with a second dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM in the left deltoid. That evening, the patient had a seizure. Medical attention was sought in the office. Spectrascopy test result was normal; unknown when the test was performed. There was no fever post vaccination. Subsequently, the patient recovered from the seizure. Upon internal review, the seizures were considered to be Other Important Medical Events. Additional information has been requested.
Heavy bloody nose; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Jun2021 at 12:00 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15May2021 at 12:00 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 05Jun2021 at 12:00, the patient experienced heavy bloody nose within 5minutes of receiving vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event heavy bloody nose was recovered on 05Jun2021.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant and refers to a currently 6 months old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PEDVAXHI, lot # K015464 with expiration date 09-JUL-2017 (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Headache, wavy eyesight, hearing like through a tube, some loss of equilibrium.  Visual and auditory reaction lasted 7 hours.  Equilibrium reaction lasted 1-1/2 days.   This was followed by left ear tinnitus.
Brain Fog; Arm very sore; Chills at night time; Fatigue; nausea; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), FEELING ABNORMAL (Brain Fog), VACCINATION SITE PAIN (Arm very sore), CHILLS (Chills at night time) and FATIGUE (Fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis. Concomitant products included FISH OIL and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Body Aches), VACCINATION SITE PAIN (Arm very sore), CHILLS (Chills at night time), FATIGUE (Fatigue) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Brain Fog). At the time of the report, PAIN (Body Aches), FEELING ABNORMAL (Brain Fog), VACCINATION SITE PAIN (Arm very sore), CHILLS (Chills at night time), FATIGUE (Fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
This spontaneous report as received from a nurse refers to a 6 months 1 day old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt received smallpox vaccination on 15 Nov 03 in Left arm.  Four days after that PT c/o of not feeling well and visited the clinic.  Patient was adminstered the FLU vaccination.  Pt stated at time of the flu vaccination he did not have a fever.  About 1 week after the flu vaccination patient started to exibit flu like with excreciating pain at the smallpox vaccination site and lower back.  Pt was treated in hospital for 5 days with IV antibiotics.
injection site red, inflammed, warm to touch, and painful size between quarter and half-dollar. Benadryl 25 mg Po one time given
About 9 days after vaccine administration, patient developed minor rashes over parts of his arms and front of torso.  No pain, but significant itching.  Rashes have lasted for several days.
On 30MAY90 pt vaccinated 1st dose of vax later that evening experience nausea, vomiting, & severe pain in her arm; 31MAY90 numbness of the arm, & swelling, tenderness & induration over deltoid muscle; Area was red & warm to touch;
Abdominal cramping and pain; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of abdominal cramp in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced abdominal cramp and pain. On an unknown date, the outcome of the abdominal cramp and pain were unknown.   It was unknown if the reporter considered the abdominal cramp and pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR019700  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received his/her 1st dose of Shingrix and experienced abdominal cramping and pain which were most notable side effects. The follow up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR019700.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR019700:same report, 2nd dose
CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 31 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection. This report was non-serious.; Sender's Comments: V0:As per standard protocol, No MAC comment is required for non serious case
Patient had high fever, muscle aches, and chills the evening of the vaccination (approx 6 hours later). The next day, she went to the ER with chest pain and painful breathing. At the ED, her liver enzymes were found to be elevated while her white blood cell and platelet counts were low.
Patient was administered high-dose flu shot instead of fluzone quadrivalent dose (age appropriate dose).
Immediate pain in left shoulder. Pain continuous 24/7. Unable to use left arm. Returned to doctor's office and prescribed Ibuprofen; referred to Orthopedic specialist. MRI confirms rotator cuff tear. Surgery scheduled for 12/16/2013.
Second day: sore arm and neck (over by next morning), dizzy spells and nausea (ended by evening), temp 100 (normal by next morning).
Vaccine given in office today 12/14/21, vaccine was expired on 12/13/21 at 5:09 pm, no adverse events at this time. Local health department has been contacted, VAERS report form is being filled out and contacting Pfizer manufacturer. Family was notified.
lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the 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.
Post vax, in August 2000, the patient developed a generalized rash. The patient sought unspecified medical attention. Additional information has been requested.
On afternoon of receiving vaccine, pt noticed tenderness, redness and itching at the injection site. Also a knot developed at the injection site that continued to get larger for 2 days. Pt states the swelling and itching was unusual for her. By 10/31/14, improved but still reports itching and some swelling.
About 2 hours after dose at 11 AM I noticed that both ears had become "plugged." The sensation was similar to being on airplane with plugged ears from pressure decrease. It was not a ringing or buzzing sensation; just a dullness in my ability to hear. It was not painful. When I awoke in the morning the sensation was gone, without any lingering issues beyond the expected soreness of arm and mld body ache.
The right side of my face has lost most movement above the mouth.   Paralysis for short.
7 days after vaccine noted patch of itching/red/macular rash like contact dermatitis about 4 inches all around injection site. Responding well to hydrocortisone and antihistamine
Patient was administered vaccine after published expiration date 07/07/2022 in error. we failed to read the fine print on the packing slip and thought that the expiration date was the place code. we have  taken corrective measure for this error not to happen again. We have also contacted Moderna and their team is conducting analysis concerning this patient for a product assesment.
No additional AEs; vaccine administered after reconstitution with expired sterile diluent; vaccine administered after reconstitution with expired sterile diluent; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 07-JUN-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD), 0.5 milliliter (ml), administered subcutaneous (lot# U010742, has been verified to be a valid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live [rHA] [PROQUAD], expiration date reported as 03-OCT-2022, but upon internal validation established as 02-OCT-2022) as prophylaxis, The vaccine was reconstituted with an expired sterile diluent (manufacturer unknown), 0.5 ml, subcutaneous (lot# S030249, has been verified to be a valid lot number for sterile diluent, expiration date reported as 02-JUN-2022) (Product preparation issue) (Expired product administered).  No additional adverse events reported.