chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headaches; Fever 101.8; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and PYREXIA (Fever 101.8) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches) and PYREXIA (Fever 101.8). At the time of the report, HEADACHE (Headaches) and PYREXIA (Fever 101.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) High.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
started to flush slightly; First dose: administered on 05Apr2021/Second dose: administered on 14Sep2021; This is a spontaneous report from a contactable consumer (patient herself). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection and Lot Number: EW0185) via an unspecified route of administration in arm right on 14Sep2021 10:23 (age at vaccination 37 year) as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history included Penicillin allergy and compromised immune system. The concomitant medications were none. Patient historical vaccine included hepatitis A for immunization which caused hives (several years ago). The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: ER8729) via an unspecified route of administration in right upper arm on 05Apr2021 at 15:30 as single dose for COVID-19 immunization and experienced with Pain at the injection site of her right upper arm, Severe flushing and tingling in upper lip and tongue. Initially he advised her against getting the second dose of the Pfizer COVID-19 Vaccine until there was more data available. Reporter stated with the new data coming out last month about safety of giving the second dose of Pfizer COVID-19 Vaccine after a patient has a reaction to the first Pfizer COVID-19 Vaccine that the physician felt it was safe to give her the second dose of Pfizer COVID-19 Vaccine. She was approved to get the second dose of Pfizer COVID-19 Vaccine with pre-medication. On 14Sep2021 at (Withheld) Hospital she was pre-medicated with 25mg of Benadryl and 20mg of Pepcid. She was administered second dose of Pfizer Covid-19 Vaccine on 14Sep2021 at 10:23. She started to flush slightly around 10:40. She was administered 25 mg of Benadryl and that resolved the event of started to flush slightly. She had no further incidents, was able to tolerate the second dose. She recovered completely from this event within about 24 hours also. They did not send her to the emergency room this time, they felt that the reaction was well controlled with the antihistamines. On 15Sep2021, the outcome of the event Flushing was resolved.
REC'D ANTHRAX VACCINE 24 JAN 03 MALAISE AND FATIGUE 25-26 JAN 03--NO FEVER TONIC CLONIC SEIZURE LESS THAN 5 MIN DURATION ON THE MORNING OF 27 JAN 03; POSTICTAL 1 HOUR ALL LABS, CTS, AND EEG WNL PATIENT RECOVERING AT HOME NO ADMISSION
Sweating; Swollen arm; 103 F. fever; Chills; Nausea; Voimiting; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Swollen arm), PYREXIA (103 F. fever), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Swollen arm), PYREXIA (103 F. fever), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Voimiting) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. In April 2021, HYPERHIDROSIS (Sweating), PERIPHERAL SWELLING (Swollen arm), PYREXIA (103 F. fever), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Voimiting) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 103 f (High) 103 F.         No relevant concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Events end date and outcome added.
Patient reports having low blood pressure, head aches, low energy, dizziness, and light headedness.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 21-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
report fever, fatigue and HA . Treatment- Tylenol. Outcome- Mild improvement does not interfere with ADLs.
At 5 pm, she started with her left upper arm being hot and itchy, small hives, went away with in minutes it moved to her right upper arm, went away moved to the front of neck, went away then moved to her back.  Same symptoms hot, swollen itchy a few hives. At 11pm she woke up very angry, sobbing, screaming, wouldn't let me comfort her, after 10 minutes she finally told me her skin was burning, itching, wants it to stop.  Tried calamine lotion first, no help.  Bath soak seemed to help a little.  She was still irritated until about 2 am then she calmed down and finally fell asleep.  She still thrashed around alot until about 330 am.   11/11/09 She states she is feeling fine, decreased appetite.
Her leg started bothering her, the pain was quite heavy and consistent; pain under her left arm; blood cloth in her leg; a little nauseous; headache; tired; pins; A spontaneous report was received from a consumer concerning a female patient of 70-years-old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Pins/ Paraesthesia,nausea,tiredness,headache,pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm.  The patients medical history was not provided .Concomitant medications reported included Eliquis starter pack twice a day,Latanoprost for Glaucoma,Omeprazole for heart burn.  On 15 Jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 037K20A) vaccine via unknown route for prophylaxis of COVID-19 infection.  On 12 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 024M20A) vaccine via unknown route for prophylaxis of COVID-19 infection  On 12 feb 2021,That evening she got pins again.The next day she was a little nauseous, tired and had a headache. Her leg started bothering her 3 days to a week after the second dose.And the pain in her leg was quite heavy and consistent, she thought it might be her sciatica. She went to the doctor and ended up getting a doppler and they discovered a blood clott there. She had never had a blood clott before in her life.she was feeling pain under her left arm as well.  No Treatment for the event was provided.   Action taken with the mRNA-1273 in response to the event was not applicable.  the event pins were considered resolved on 13 Feb 2021.  The events nauseous,tiredness,headache were considered resolved on 14 Feb 2021.  The outcome of the events pain in leg was quite heavy and consistent, blood cloth in leg, pain under left arm was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Information has been received from a pharmacist referring to a female patient of unknown age. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (route, lot# and expiration date unknown). On an unknown date the patient developed an unspecified rash  a month after receiving ZOSTAVAX. The patient said that the rash cleared (recovered) within two days after it appeared. The reporting pharmacist was offered the varicella zoster virus (VZV) information but declined. Additional information has been requested.
Clogged ear causing vertigo, vomiting,  severe headache, chills.
Case number PHEH212US015523 is an initial spontaneous report received from a nurse on 01 Aug 2012: This report refers to a 21-months-old female infant. She was vaccinated with MENVEO (batch number: A11052/X11052) intramuscularly on 01 Aug 2012. No adverse event was reported following this medication error.
"brain Fog", anterograde amnesia  to the events of the day. lost track of what she was doing and where she  was for  brief moments. Noted leg weakness on the right.
Patient reported that the morning after his vaccine, he had severe neck pain, when he looked in the mirror he had facial drooping on one side of the face consistent with Bell's Palsy. He went to ER and they released him, stating that there was nothing that they could determine to be the reason why he had the facial drooping.
Approximately 24 hrs. after vaccination, parent noted swollen, red at injection site.  Symptoms resolved; then developed rash on anterior chest - seen by physician on 7/31/08 & noted to be chicken pox.
Information has been received from a nursing assistant concerning a female who about 2 months ago was vaccinated with a second dose of GARDASIL. After vaccination the patient fainted and hit her head. The patient was fairly warm in the examination room. The patient had a cut on her head and her lip from the fall off of the examination table. Steri - strips were placed on her head. The next day the office contacted the patient and she was fine. The patient sought unspecified medical attention. Follow up information was received from a healthcare professional who indicated that the patient was a 15 year old female with no known drug allergies and no pertinent medical history who on 04-JUN-2009 was vaccinated intramuscularly with her third dose (previously reported as second) of GARDASIL in her right arm at 15:45. No illnesses were reported at the time of vaccination. According to the reporter, the patient was seated on bed receiving the injection; the patient stated that she felt hot and nauseous. It was reported that the nurse turned to open the door while patient was seated on the bed. Subsequently the patient tried to stand up, she fell and hit her head on the floor. Steri - trips were used on her left fore head. The patient recovered on 10-JUN-2009. No further information is available.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/2/2023 Discharge Date: Feb 13, 2023  PRESENTING PROBLEM: Hypoxia [R09.02] Acute congestive heart failure, unspecified heart failure type [I50.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 83 yr old F with PMHx of diastolic heart failure, Hx of CVA with LUE paralysis and LLE weakness, atrial fibrillation on warfarin, pulmonary hypertension on 3 L of oxygen presented to ED with worsening shortness of breath and cough.   Patient stated that few days prior to admission - her husband tested positive for COVID-19 and given the proximity to him she also started a low some symptoms of cough and shortness of breath.    Her oxygen needs went up from 3 liters/minute to 5-6 liters/minute in ED.  Chest x-ray done in the emergency room showed pulmonary vascular congestion with bilateral infiltrates which is atelectasis versus pneumonia. Testing was +COVID on PCR. She was admitted on decadron for COVID and IV lasix for pulmonary congestion. TTE showed EF 65%. Her O2 needs returned to baseline 3L. She was transitioned to home lasix regimen.   PT/OT recommended SAR placement. Regards to her DM II - glucose levels remained labile while on Decadron but ultimately improved. She completed her isolations period and was discharged to SAR in stable condition on her baseline oxygen (3L) on 2/13/23.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 23-DEC-2015, the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) after being improperly stored (incorrect product storage) (Temperature: 9.5 F, Time frame: 2 hours). No adverse effects were reported. The outcome of incorrect product storage was unknown. Additional information has been requested.
Patient experienced inflamed red welts all the way down her arm. Soreness for over a week. *Right arm only*
Information has been received from a Pediatrician via medical records concerning a male baby who was born to a 23 year old mother with allergy to anything in the "cillin family", PPD skin test positive and a history of caesarean section and tuberculosis exposure. It was reported that the mother had one previous pregnancy and one full term delivery. On 05-SEP-2008, 05-NOV-2008 and 16-MAR-2009 the mother was vaccinated with the first, second and third dose of GARDASIL, respectively (Lot # for the third dose: 661953/1130X). Her LMP was 16-FEB-2009. On approximately 17-MAR-2009, the mother experienced sharp pains located "4 inches below her belly button and 4 inches to the left of her belly button". She stated the pain might due to a previous caesarian section (see WAES #0903USA02927). On 16-NOV-2009, the mother delivered a normal, healthy male baby weighing 8 pounds, 6 ounces, length 21 inches. The mother had no complication and no infections or illnesses during pregnancy. The mother had no complication during labor/delivery. On an unspecified date the baby had a circumcision. On 12-APR-2010 the baby had a 4 month follow-up visit. It was reported that the baby was breast feeding 6 ounces every 2-3 hours and he was up 2 times at night. His height was 26 1/4 inches; weight was 18 pounds 6.5 ounces. Physical examination showed birth mark on his forehead and small Mongolian spot on his buttocks. The assessment was normal 4 month exam. On the same day the baby was vaccinated with the first dose of PREVNAR (lot #E38312) in the left, hepatitis B vaccine (Lot #AHBVB79CKA) in the left and PENTACEL (Lot# C355S7AA) in the right. Birth mark on his forehead and small Mongolian spot on his buttocks were considered to be congenital anomalies. Additional information has been requested. All available medical records will be provided upon request.
Several hours after the vaccine was administered, the recipient felt very weak, and vomited about 4 times. Also had a constant headache and ran a fever, with chills.
Small rash on scattered parts of body, arms, legs, and hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on scattered parts of body, arms, legs, and hands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Small rash on scattered parts of body, arms, legs, and hands). At the time of the report, RASH (Small rash on scattered parts of body, arms, legs, and hands) had not resolved.            Treatment medication reported included an unspecified cream.  No concomitant medication was reported.
Child became faint upon rising from the chair after the injection. Helped to the floor. Her feet were elevated and she transitioned to a sitting then standing position. Walked on her own independently from the clinic.
Reaction: Red dots on bilateral arms, no itchiness or warmness Outcomes: Observed for an additional 15 minutes, gave Benadryl 25 mg PO x1. Decreased redness after 5 min of Benadryl
No additional AE's/PQC's reported; Temperature excursion for VARIVAX; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.   On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (strength, dose, anatomical location, and route of administration were not reported) (lot# U015682 with an expiration date on 18-MAY-2023) for prophylaxis wich experienced a temperature excursión of 4°C Celsius degrees for 20 minutes on 07-SEP-2021 during transport and 4°C for 20minutes on 09-SEP-2021 during transport as well as -10°C to 8°C (4°C) for 20 minutes (product storage error).  It was reported previous temperature excursions of -10°C to 8°C (4°C) for 7 hours and 30 minutes.   No additional adverse events were reported.
Severe left shoulder pain, radiating to shoulder blade for approximately one week.  Since then, "burning" type skin pain L shoulder blade, deeper with less than baseline / nearly numb in deep tissue if shoulder blade pressed.
Fever; Hives; This is a spontaneous report received from a contactable other health care physician (patient, self-reporting). A 51-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EK9231) via intramuscular route of administration on 28Jan2021 16:15 (at the age of 51-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included estrogens esterified, methyltestosterone [Estratest] received orally for HRT (hormone replacement therapy) started on 02Jan2021 till 01Mar2021. Patient was not pregnant at the time of vaccination. Prior vaccination within 4 weeks was reported as None. Patient's medical history including any illness at time of vaccination and relevant test was reported as None. The patient experienced hives on 28Jan2021 20:00 and fever on 29Jan2021 06:00. Therapeutic measures were taken as a result of hives and fever with Ibuprofen, Acetaminophen and Benadryl. Outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
I developed at fever of 103.9 tympanic after about 12 hours which lasted for 2 days. The fever decreased after about 48 hours but I continued to have a low grade fever (100-101 F) for the next few days with night sweats.
This is a spontaneous report by a contactable medical assistant calling on behalf of a physician. A male patient of unknown age and race received the first dose TRUMENBA at 0.5ml single dose for immunization on unknown date. Medical history and concomitant medication were not provided. The patient experienced the headache and pain at the injection site for 12 hours. The medical assistant described pain at injection site as hypersensitivity to the upper body for 12 hours. The outcome of the events was unknown.
Pain in Left arm and injection site, swelling, redness - I still have pain in the Left upper arm at the injection site and surrounding the upper arm and shoulder 9 days after the injection. The arm is quite painful and presents difficulties with some movements.
Return of intermittent episodes of atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 25May2021 as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, high cholesterol, taking Synthroid due to thyroidectomy, and experienced atrial fibrillation from 2016 to 2016. The patient had no known allergies. The patient's concomitant medications included metoprolol tartrate; clonidine (CATAPRESS); levothyroxine sodium (SYNTHROID); enalapril; and atorvastatin calcium (LIPITOR). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), administered in left arm on 04May2021 for COVID-19 immunisation. The patient had no other vaccine in four weeks. On May2021, the patient experienced return of intermittent episodes of atrial fibrillation. Back in 2016, the patient experienced Afib that was ultimately found due to extremely high thyroid hormone levels. In 2016-2017, she took thyroid inhibitors, had thyroid ablation and ultimately thyroidectomy. The event resulted in  physician office visit. No treatment was received for the event. The patient had no COVID prior vaccination and has not been tested COVID post vaccination. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone (TSH): normal on Apr2021. The outcome of the event was recovering.
Patient under the age of 18 received Moderna vaccine by technician. No known side effects/ symptoms at this time reported.
I developed ringing of my left ear (tinnitus) and some vision changes (blurriness that I need to have my eyes check and increase the grades of both my eyes
After approx. 10hours of receiving the vaccine in my left arm-shoulder at work , I was sleeping and was awakened  With:  SEVERE CHILLS - teeth chattered in my head & legs shook -uncontrollably for over 9  hours  FEVER- 103 Degrees -on & off for 8 hours BURNING - STINGING - in both hands and turned red 1-2 days LEFT ARM - sore- swollen  1 week [LEFT ARM - still has aches and stiffness] HEADACHE- -top of head  for 2 days JOINT PAIN -all over for 3-4 days WEAKNESS- for over 72 hours