chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Strong symptoms of Covid, Sever chills followed by weakness, nausea and a High temperature. My spouse then exhibits signs of Covid 2 days after my shot. Lose of taste and smell that lasted several weeks
This spontaneous report was received from a licensed practical nurse (L.P.N) via a telephone call, concerning a 12 month old female patient. No concurrent conditions or medical history were reported. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018142 Expiration date: 10-APR-2016) (dose, frequency and anatomical location of administration were not reported). No concomitant therapies or adverse experiences were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site). At the time of the report, VACCINATION SITE PRURITUS (red itchy rash on the injection site), VACCINATION SITE ERYTHEMA (red itchy rash on the injection site) and VACCINATION SITE RASH (red itchy rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Non significant follow up added. Email address updated.
Date and time of vaccination: (list both if they received both shots):   First dose: 02/20/2021 @01130, second dose: 03/19/2021 @01130 Brand and lot of vaccine:   Moderna LOT(M030M20A) (048A21A) patient reported that she developed a fever and arm sorness today (03/20/2021) @730.  instructed to take tylenol to help with the fever. patient was instructed to apply cold compress to help with the arm sorness. patient was instructed to seek medical attention if the symptoms got worse.
Diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). At the time of the report, COVID-19 (Diagnosed with COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No Adverse Event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 33th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but it was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
I have chronic migraine, post receiving this vaccination my migraine frequency and severity increased for several weeks. To date it was not reverted back to my normal pattern (4 weeks later). My normal pattern is currently 3-4 migraines per month, I am currently having migraines every day. The first migraine started 12-14 hours after the vaccination.
pt exp shortness of breath; swollen tongue; wheezing; resolved same day; 9/15 pt exp an exacerbation of Sx; hosp; as of 9/16 pt still in hosp; stable condition; tx: breathing tx & intravenous steroids;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Information was received on 06-OCT-2017 from  a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route and lot # were not reported) on or about 10-SEP-2014 at a physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about  22-JUN-2016, the patient was treated at an Urgent Care Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Daily headaches since booster shot. Over two weeks of headaches since being boosted. All other ?typical? symptoms lasted a few days and went away. Headaches have persisted.
No reaction until Day 8 at which time developed itching first followed by heat, swelling and red rash around the injection site.
Vaccine administered after the 10 week refrigeration expiration date .  Vaccine put into refrigeration on 10/11/2022.  10 week expiration would have fell on 12/20/2022. Vaccine received on 01/20/2023 .  Patient had no symptoms or problems due to receiving the dosage.  Pfizer contacted on 02/06/2023 to determine the efficacy of the dose, pending final determination.
Very large amount of swelling 24 hours after DTap vaccination on left thigh. Redness and swelling wrapped around upper thigh greater than 5 inches in diameter. Swelling increased in size 48 hours after injection. Warmth coming from swelling site and my son was scratching it. 72 hours after vaccinations, my son threw up one time and had diarrhea one time.
mom states pt had fever day of vax; APAP was given; denies any adverse sx or events; states pt was well in good health;
3 cm x 5 cm patchy erythematous maculo papular rash @ site of immunization.
No additional adverse effect reported; underwent a temperature excursion was administered to a child; This spontaneous report was received from a medical assistant and refers to a patient (child: age unspecified) of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAR-2021, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T019420, expiration date 02-DEC-2021 (formulation, strength, route of administration and dose were not reported) for prophylaxis.  On an unknown date in February 2021, the dose of the vaccine was exposed to temperature excursion at 23.1 Celsius degrees (C) for 1 hour 36 minutes. There was reported previous temperature excursion at - 15.5 C for 2 hours 48 minutes. The call was due to digital data logger. No additional adverse event was reported.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient had an antibody titer value of 5, 20, 20, and 80 after 0 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of B strain. Therefore this patient was considered as an LCI case of Influenza B. The outcome was not reported.
PATIENT IS COMPLAINING OF NAUSEA, DIZZINESS AND IS INCOHERENT SINCE THE VACCINATION.
p/ pt recv vax approx 1 yr later devel 3 vesicular eruptions on the abd. & vomiting, vesicular eruptions appeared similar to those seen w/varicella infect. pt dx w/poss mild varicella
The pt experienced lightheadedness, 2 hours later felt faint and proceeded to the ER. The pt's throat then tightened and became short of breath. The pt was treated with Ativan.
arm was very heavy; dry cough; vomit; headache; chills; bones hurt; fever; right arm was swollen; feels tired; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (yesterday at 1:00 p.m) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced felt her arm was very heavy, at night had a lot of dry cough and about 2-3 times during the day, after which she was vomit, headache, chills, bones hurt, fever, right arm was swollen and when she does something and feels tired on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reports intense pain that has been unrelieved after several weeks. Also reports significantly decreased range of motion.
left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm sore) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced MYALGIA (left arm sore). At the time of the report, MYALGIA (left arm sore) outcome was unknown. Not Provided      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 concomitant medications reported by investigator  No treatment medications provided by the reporter.
FEELING COLD AND HOT; ACHING/PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, the patient experienced feeling cold and hot. On 04-MAR-2021, the patient experienced aching/pain. On 04-MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from feeling cold and hot, aching/pain, and fever on 05-MAR-2021. This report was non-serious.
Incorrect Dose. Moderna booster dose administered: 0.5 milliliters. Booster dose should have been 0.25 milliliters.
Upper lip swelling on date of vaccination 1/5/21 starting on 1/8/21, developed severe generalized urticaria - still active
Left side, arm, chest and face felt very swollen and numb. No visible swelling or redness or hives or anything Started about 20 minutes post vaccine and lasted about an hour
really intense pain in arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really intense pain in arm), PYREXIA (fever) and CHILLS (chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRETINOIN and CLINDAMYCIN for an unknown indication.    On 09-Mar-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 (really intense pain in arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (really intense pain in arm), PYREXIA (fever) and CHILLS (chills) 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.   concomitant medication include Tarina Birth Control
Patient is only 15 years old and received the 65 and over flu vaccine. She should have received the 65 and under flu vaccine.   patient has not had any reported events from receiving this vaccine, but it is a medication error as she received the wrong flu vaccine based on her age.
itching, swelling, body hives; given script for DPH & steroids; Only used DPH; resolved;
After admin of HPV pt. felt dizzy. I had her lay down and she fainted on the way down. Came back soon after. Looked  at by RN normal pulse. Stayed for 15 min before leaving.
Severe chills and fever starting early evening and spiking at 102.3 F. at 11:00 pm and then breaking about 3 am. The next day noticeable redness left side of chest. Diagnosis at Urgent Care visit of Shingles.
Bruising on thighs, calves, arms. No trama that would have caused it. Started to appear 4to 5 days after first vaccine
Heart palpitations, difficulty regaining endurance with exercise, dizziness with strenuous exercise for 2 months
Local erythema/induration about 10cm, nausea, fatigue, ? fevers.
ITP-bruising, red spots noticed bruising & sought treatment as it grew worse over a 3 days period;recv platelet tx & retesting for 6mo;
ved-Information has been received from a physician concerning a female who on 15-FEB-2007 was vaccinated IM with a 0.5 ml dose of Gardasil (lot # 653736/0868F). On 09-MAY-2007 the patient developed weakness and paresthesia of the upper and lower extremities. The patient was hospitalized from 09-MAY-2007 to 14-MAY-2007. The diagnosis was determined to be transverse myelitis. Details of the hospitalization and treatment were not available. The physician reported that the patient had required additional hospitalization but the details were not available. At the time of the report, the patient's transverse myelitis persisted. Additional information has been requested. 8/29/08-from CDC-19 y/o female who received the vaccine on 2/15/07, chart indicates she refused second dose because of symptoms after first dose (although not clear), on 5/17/07 she was admitted for leg weakness/numbness.  The working diagnosis was TM although occasional back spasms had them consider seizure disorder as well.  She experienced her nadir of no sensation to chest level and inability to walk.  At one point ONM was also considered though unclear.   After which she also developed seizure disorder. Final dx (thusfar): TM and MS*. She seemed to have improved in general.  10/3/08 Reviewed hospital medical records of 5/9-5/14/2007. FINAL DX: transverse myelitis w/left sided weakness (neuro suggested Devic's disease/neuromyelitis optica); back arching spasms; questionable seizure disorder Records reveal patient experienced left side weakness & paresthesias x 1 day.  Neuro consult done & exam abnormal.  Tx w/high dose steroids x 5 days w/o improvement.  Transferred to higher level of care.  10/15/08-records received for DOS 5/14-5/17/08-DC DX:transverse myelitis. One week of progressive left-sided weakness and numbness. Left sided weakness.
1425 Pt reported feeling light headed and dizzy. VS: 125/61, 75, 95% RA, Temp 99.0. Pt was given water to drink and observed for additional 10 minutes. 1445- Pt reported feeling "much Better" and left site at 1451 -  RN
Developed Hives face, neck and trunk 10 min after Hep A given. Pt observed 30 minutes and sent home with BENADRYL RX to give.
crying, body having uncontrolable, spasms,seizures; leg weakness to both my legs from my hips to my knees; "twitching" to my face; chronic pain; weakness; fever 102.6; nausea and vomiting; nausea and vomiting; headache that exacerbated migraines; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (crying, body having uncontrolable, spasms,seizures) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Aspirin), Sulfonamide allergy, Migraine and Asthma. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Herpes NOS, ATORVASTATIN for High cholesterol, METOPROLOL for Hypertension, AMITRIPTYLINE for Insomnia, TOPIRAMATE for Migraine.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MIGRAINE (headache that exacerbated migraines), PYREXIA (fever 102.6), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting). On 27-Jan-2021, the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced SEIZURE (crying, body having uncontrolable, spasms,seizures) (seriousness criterion medically significant), MUSCULAR WEAKNESS (leg weakness to both my legs from my hips to my knees), MUSCLE TWITCHING ("twitching" to my face) and PAIN (chronic pain). On 27-Jan-2021, MIGRAINE (headache that exacerbated migraines) had resolved. On 28-Jan-2021, ASTHENIA (weakness), PYREXIA (fever 102.6), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting) had resolved. At the time of the report, SEIZURE (crying, body having uncontrolable, spasms,seizures), MUSCULAR WEAKNESS (leg weakness to both my legs from my hips to my knees), MUSCLE TWITCHING ("twitching" to my face) and PAIN (chronic pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Magnetic resonance imaging: negative (Negative) Negative. On 27-May-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 27-May-2021, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Computerised tomogram: negative (Negative) Negative.         Treatment medications was not reported.  The action taken with mRNA-1273 was Not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 - New events added (Case upgraded to serious); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Grapefruit size lump in armpit on the side the vaccine was given., swollen lymph nodes and glands in neck and body on the same side.. pain under shoulder blade of the same side..