chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased PMS symptoms, for one full week before period started; Spotting; Cramping; Dizziness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported was not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included IBUPROFEN and SONATA, both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on an unknown date in Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021, the patient experienced increased premenstrual syndrome (PMS) symptoms, for one full week before period started, including spotting, cramping, dizziness, fatigue. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of the event. The clinical outcome of the event increased premenstrual syndrome (PMS) symptoms, for one full week before period started, including spotting, cramping, dizziness, and fatigue was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Myalgia, Fever, extreme sweating, headache, slight sore throat, light headed, ringing in ears, arm pain, fatigue, loss of vision/eye pressure Narrative: 1/6/21 around 7:30am patient states was extremely hot, visibly sweating, could not cool down and left work. Around 10:30am began having uncontrollable chills and shivers temperature was 100F while on Tylenol. Also headaches and pressure, slightly sore throat, light headedness, ringing in ears, arm pain at the injection site to elbow, muscle aches and fatigue. on 1/7/21/fever was gone but there was a lot of pressure in the head and eyes. Eyes had "floaters" in dim light and loss of peripheral vision in the light. This episode lasted for 30 minutes and then cleared. There continues to be pressure in the eye and head, arm soreness, ringing, and lightheaded.
At 3:30 pm following vaccine she began vomiting and developed muscle spasms in legs and toes.
Mother returned to clinic for evaluation of injection site on 1/11/02, injection given 1/8/02-Erythema & slightly raised area of deltoid approximately 40 mm X 30 mm-no complaints from patient. Discussed Benadryl should area itch, cool compressions.
She broke out with extreme hives all over her body. We went on vacation and had to take her to a doctor out of state 2 days after the vaccine for steroid meds and allergy meds because benadryl was not working.  When the hives started it was just a few and I called clinic after hours #.  They told me to use cortisome cream and if it got worse Benadryl. 2 days later she was worse & we ended up at a drs. office.  At that time she had also started running a low grade temp.  The pricked her finger and ran a blood test and said she had some type of bacterial infection.
Pt developed pain and weakness from the left shoulder down the arm. Weakness progressed to the point of inability to lift arm. With physical therapy pain is resolved and weakness is improving.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided. This case was linked to MOD-2021-052065.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: initial bp: 99/60 hr 65 and 10 minutes later 112/73 and hr70
Patient is an 81 y.o. male who presented to the Hospital ED from home on 11/29/2022 with weakness and inability to ambulate following 3 days of a sore throat, malaise and limited dietary/fluid intake.    Discharge Diagnosis and Associated Hospital Course   COVID-19 related pneumonia with dehydration Presented with viral-symptoms inclusive of  myalgias, sore throat, cough and weakness from which he has clinically improved - Symptom onset: 11/27/2022 - Positive COVID-19: 11/29/2022 at Hospital  - Vaccination status: Moderna series with boosters x 3  - CTPE: negative for emboli; ground glass opacities right upper and lower lobes - Oxygen status: stable on room air  - Hypoxemia: isolated value recorded at 85% in ED with a range of 95-99% with low for oxygen by nasal cannula at 2 L/min - Dexamethasone: 6 mg x 1 on 11/29; discontinued 11/30/2022 given no history of COPD and clinical timeline (presented on day 4 of illness) - Remdesivir: Yes. Started 11/29/2022. Received 3 doses while hospitalized   Acute cystitis Urine culture returned with Escherichia coli sensitive to cephalexin -Plan for 7 days of therapy   Benign prostatic hyperplasia with LUTS Historical symptoms include frequency, nocturia, and incomplete emptying established with urology this has been controlled with alfuzosin   History of left ureteral stone status post ESWL Bladder stone Known to Dr. with tentative plans for cystoscopy evaluation and extraction; as above treat for suspected UTI  CAD Hyperlipidemia No active ACS; continue with aspirin and statin therapy   GERD Continue home deslansoprazole   History of lumbar stenosis with residual peripheral neuropathy  History of chronic daily headache Status post surgery; continue gabapentin
Patient developed temperature to 103.8 rectally and tonic clonic seizure activity that lasted 5 minutes on evening on 3/31/2004
Shot Saturday, swollen knot on right wrist Monday - painful. Swollen clavicular node and cervical nodes Wednesday- painful (Right). Swollen tissue in right shoulder and chest. Headaches almost everyday clouded thinking and slowed memory function.
Arm swelling red and hot. Within 12 hours. Also severe muscle soreness of upper body. Tender to the touch. Headache. All within 12 hours of the vaccine
14 hours after dose symptoms as follows. Nauseous, fever and body aches lasting 24 hours.
I woke up with a rash under my breast and in both sides of my neck. It is no itchy and no bumpy.
This spontaneous report as received from certified medical assistant refers to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown dates the unspecified number of patients were vaccinated with improperly stored doses of VAQTA (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
It was reported that a 19 year-old female patient received a Menomune A/C/Y/W-135 vaccination administered on 03-Oct-2001. Two hours after vaccination, the patient developed a fever of 101 f. During the night, the patient woke with back pain from lumbar to base of neck. Patient was seen in physician's office. The pain continues with 99.1 F temperature unresolved.
Patient received Td vaccine on 7/2/07 for wound management.  On 7/4/07, patient experienced malaise, severe pain in arm that received vaccine that resulted in an inability to move her arm for more than 24 hours.
Information has been received from a physician concerning a 1 year old patient who in the middle of March 2006 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). Two days after being vaccinated, the patient developed a fever of 103 degrees. medical attention was sought. The high fever lasted for four days. Six days after being vaccinated, the child's temperature returned to normal. Additional information has been requested.
Covid monitoring documentation. PT admitted 1/21/22 documented to have positive covid. PT received Moderna 03/17/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 4/14/21 Lot 036B21A.
pt recv vax & 4min later pt devel an allerg rxn characterized by wheezing, facial swelling, & excessive crying;tx in MD office w/DPH, dexamethasone & epi, then transported to ER for observation;recovered w/in 24hr;
Pt reported rash on face on wednesday 11-08-2023 and will report to doctor on friday 11-11-2023 if rash doesn't resolve ....Patient had Covid 19 in early October 2023 with symptoms.
1/16/22 Our records show patient had a positive COVID test at local Community Hospital; patient passed away in the hospital.
Pt presented to ED Covenant Hospital on 01/20/2022 for fever associated with cough and SOB for 3-4 days.   Upon arrival to ED patient was found to have BP 171/70 with temp 101.1° F with RR 20 with HR 82 with SpO2 96% on NC O2.  After eval in ED patient was found to have HB 8.7 with elevated ferritin 1553 with glucose 152 with BUN/creatinine 76/2.5 within normal HS troponin/lactic acid with elevated CRP 22.4 with elevated procalcitonin 0.55 with elevated D-dimer 1430.  Influenza/RSV negative.  COVID-19 positive.   Patient was admitted for further management of acute hypoxic respiratory failure with COVID-19 pneumonia and she was started with NC O2/Decadron/Remdesivir/vitamin-C/vitamin-D/zinc.    Initially patient required 5-6 L NC O2 which gradually improved to 3 L.   PT/OT recommended post acute care.  However patient wants to go home with home health care.   Over the course in the hospital pt,s fever subsided and cough/SOB improved significantly.  She is on 3 L NC O2 now and is on 2.5 L NC O2 at home during the day.  She uses CPAP at night at home.  Pt feels much better, eating fair, getting PT/OT and her vitals are stable.   She is d/ced home with f/u with PCP.
I thought I had a sinus infection and a sinus headache. I had a fever 101.5. I was just down and in the bed. By the next day I lost my taste and smell and a sore throat, and I was giving PAXLOVID on 01FEB23. I was having high blood pressure a month later.
heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "due to a severe side effect and a heart attack after getting the vaccine". Course of event:  Reporter lost her nephew due to a severe side effect and a heart attack after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: due to a severe side effect and a heart attack after getting the vaccine
NO AE REPORTED, HOWEVER, DOSE WAS GIVEN IM INSTEAD OF SQ. PER BAVARIAN NORDIC, NO REPEAT DOSE NECESSARY
This spontaneous report as received from a medical assistant refers to unspecified number of patient of unknown age and gender.. In September 2014 (reported as "within the last month") unspecified number of patients (reported as "about 1-2 patients") were vaccinated with a d ose of improperly stored (Oka/Merck) VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. No adverse  effects were reported. Additional information has been requested.
within hours of receiving the booster, the patient experienced ongoing nausea and vomiting and early the next morning had a syncopal event. He called a family member to help but did not seek medical attention.  Even several days after the event the pt felt unsteady on his feet.
Swelling, redness warm to touch. Treatment with Benadryl/ and rest.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017 (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). Digital data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare student referring to a patient of unknown age and gender. There was no medical history or drug reaction reported. On 28-MAR-2106 the patient was vaccinated with a dose of MMR II (lot # L004656 with expired date 11-FEB-2017, subcutaneous), that was reconstituted with an expired dose of sterile diluent (L005460, 18-MAR-2016, subcutaneous). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a pharmacist via a company representative referring to an approximately 61 year old female patient. The patient's medical history, concurrent conditions, drug and allergy history were not reported. The patient's concomitant medication was not reported. On 15-MAY-2017, the patient was vaccinated with ZOSTAVAX, subcutaneous injection, lot # M039452 and expiration date 19-DEC-2017 (strength was not provided) for prophylaxis, reconstituted with a sterile diluent. On 16-MAY-2017, the patient returned to the pharmacy with red warm area around the injection site about the size of grapefruit in diameter to consult with the pharmacist. The reporting pharmacist, referred the patient to a physician office, but only if the redness went outside of an specified diameter area other than the one provided by the patient on their conversation. At the time of report, the outcome of injection site erythema and injection site warmth was unknown. The causality assessment between ZOSTAVAX and the events was unknown. Additional information has been requested.
p/vax pt had myalgias, chills, nausea & watery diarrhea which lasted at least 72 hr;
Myalgia, Diarrhea, NauseaVomiting,  chills/ swelling Narrative:  Other Relevant History:
My feet were very cold starting about a week after the vaccine. I noticed twitching and numbness in my feet three weeks after the vaccine. I started taking a new medication Nortriptyline at the same time. I stopped the new medication and the symptoms persisted. I went to the the ER to rule out Guillen Barre syndrome. The numbness and tingling were working its way up my legs. It has been ten weeks and the feeling of numbness and tingling is as far up as my knees on both legs and I am having symptoms in my wrist. My feet are burning at night and it has been getting worse. I have seen specialists and I have a neurology consultation. My doctor suspects Chronic Inflamed Peripheral Neuropathy after ruling out RA, Lupus Multiple Myeloma and Diabetes.
Sore right arm; Pain in arm travels to shoulder blade; Eyes felt like they was in his skull; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull). At the time of the report, PAIN IN EXTREMITY (Sore right arm), PAIN (Pain in arm travels to shoulder blade) and ASTHENOPIA (Eyes felt like they was in his skull) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Patient received Pfizer BioNTech vaccine on 8/25/2021 and 09/15/2021. Presented to ED 9/21/22 for SOB; COVID test + 9/15/22. O2 sat 88% on RA, placed on 2L NC. O2 requirement cont'd to increase, 9/22 placed on HFNC & intermittent rebreather use. 9/24, hypoxic to 86% on HFNC 60/60, placed on bipap with fio2 100%. Intubated and proned, increased PEEP and fio2 with worsening p/f ratio. Cont'd to decompensate and transitioned to comfort care, expired 10/7/22. Tx'd w/meropenem, levofloxacin, voriconazaole, azithromycin, decadron, micafungin,cefepime, rocephin, vancomycin azithromycin, decadron and remdesivir.
This case was reported by a consumer via call center representative and described the occurrence of welts in a 9-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT. Concurrent medical conditions included cat bite. Concomitant products included RABAVERT and Immunoglobulin. On 18th June 2017, the patient received the 2nd dose of RABAVERT. On 21st June 2017, the patient received the 3rd dose of RABAVERT 1 ml. On 18th June 2017, unknown after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced drug dose administration interval too long. On 22nd June 2017, the patient experienced welts and pruritus. The patient was treated with AUGMENTIN and BENADRYL. RABAVERT was discontinued. On 26th June 2017, the outcome of the welts and pruritus were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the welts to be related to RABAVERT. The reporter considered the pruritus to be almost certainly related to RABAVERT. Additional details were provided as follows: The case was reported by patient's mother. On 14th June 2017 at 8 PM, the patient received 1st dose of RABAVERT on left thigh with Antiglobulin. On 18th June 2017, the patient received 2nd dose of RABAVERT on right thigh which led to lengthening of vaccination schedule. On 21st June 2017 at 3 PM, the patient received 3rd dose of RABAVERT on left thigh. On 22nd June 2017, the patient developed welts all over his body and looked as if he had been dipped in boiling water. His hands were itching and the welts were on his hands, feet, thighs, a little on his chest, behind his ears and on his chin. This covered 80 to 85 percent of the body. Later, he was prescribed AUGMENTIN 750 mg and given BENADRYL and Hydrocortisone.
Adverse event started with nausea, chills, and body aches across the body. At 6:00 AM, I became very hungry, ate breakfast, and took two 500mg acetaminophen tablets which resulted in relief from body aches. I fell back asleep, woke up at 9:00 AM and was hungry again so I ate more food. I became hungry again at 12:00 PM and ate again. At 2:00 PM the body aches returned, I took two 500mg  acetaminophen tablets and fell asleep until 3:30 PM. At 4:00 PM I became hungry again and ate. At 6:00 PM I ate another meal. At 9:00 PM I took two 500mg  acetaminophen tablets and went to sleep. When I woke up the next day all symptoms had subsided.
Pt recvd vax 11SEP92 & 4 hrs p/vax devel an ulcerated area on the inside of lower lip; also had pain @ the inject site which radiated down arm;
Two days after vaccine administration right  arm excessively red and painful, warm to touch, redness from injection sight down to elbow bend of arm  spouse received the same dose of vaccine and had a similar reaction
Redness at the site of injection, warm to touch but no pain. Pt says it does not hurt.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 4/12/2023 SINUS BRADYCARDIA
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
On 5/12/02, low-grade temperature X 2 days. On 5/14/02, temperature increased with a rash on scalp. On 5/15/02, temperature increased and at 04:00, had a seizure and went to ER. Essentially febrile seizure X 2 of classic type. Treatment with Tylenol and Advil. Father had febrile seizures as an infant.
Patient was administered shot on 02-21-2022. She states 3 days later she had pain/redness and swelling at the injection site. She went to the emergency room and they gave her benadryl and told her to take benadryl prior to her second shot.
Pt was getting their first dose of covid-19 vaccine at a school clinic put on by the Health Department. After the child's first name, last name, and date of birth were verified by nursing staff the Pfizer for 5-11 year old's dose was inadvertently administered instead of the Pfizer for 12 year old's + adolescent/ adult dose. The school was notified and parent was notified.
Rash to body that has spread, itching (Papular) - started on 1/14/08.  Benadryl 12.5mg, 1/2 - 3/4 tsp every 6 hours for itching.
Nausea, headache, fatigue, chills, body aches, dizziness, near fainting, palpitations, shortness of breath.