chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient did not experience any symptoms. No additional AE information was provided.; inadvertently administered one dose of expired VAQTA; This spontaneous report was received from a nurse via a company representative referring to a 12 months old patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.   On 13-JAN-2020, the patient was inadvertently administered one dose of expired hepatitis a vaccine, inactivated (VAQTA)(strength: 25/0.5, lot # R035227, expiration date 01-JAN-2020) (route was not reported) for prophylaxis. The patient did not experience any symptoms. No additional AE information was provided.
numbness; tingling in her arm which radiated to her hand.; The injection was maybe 3 inches down from her left shoulder.  She is not sure if given in the muscle.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient).  A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 21Jun2021 around 17:00-17:30 or 17:15 as dose 1, single for COVID-19 immunization.Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, upper respiratory tract infection from Nov2019.The patient's concomitant medications were not reported.The patient previously took omega XL and fish oil (6-7 years ago).There was no prior Vaccinations within 4 weeks.On 27Jun2021 the patient experienced numbness and tingling in her arm which radiated to her hand. It was reported that the injection was maybe 3 inches down from her left shoulder. she was not sure if given in the muscle. The reporter was at the pharmacy seeking guidance whether she should receive the second of the Pfizer COVID-19 vaccine or not. She got first shot on 21Jun2021 and on 27Jun2021, her arm and hand in the side it was given became numb and tingly. It was not as bad as it was. Her hand was still tingly. She came to get second shot and pharmacist said she needs to find out if it was ok to receive second dose. The reporter mentioned she doesn't have an HCP and can't afford to go the emergency room because she does not have insurance. She was a CNA. She does not have a primary care provider. She called where she got the shot last Friday past. The pharmacist said they probably hit a nerve or something. Her whole left arm in the beginning was numb for 3-4 days and then just her hand. If she touches fingers together with thumb, she can still feel tingly sensation, but it was not as bad. It felt like when you lay on your hand like when falling asleep. It was not as aggravating as it was. The injection was maybe 3 inches down from her left shoulder. She was not sure if given in the muscle. She thinks she had COVID in Nov2019, and at the time they did not know if it was COVID and called it an upper respiratory infection. On 06Jun2021, she thought she got the new strand and after she got well, she went ahead and got the vaccine because she did not want to get it again. She does not take other medication unless it may be an Advil or Ibuprofen and was not taking any when she got the vaccine. Therapeutic measures were taken as a result of the adverse events. The patient was recovering from numbness and tingling in her arm which radiated to her hand, while the outcome of another event was unknown.
Moderna COVID-19 Vaccine EUA: patient hospitalized with acute hypoxic respiratory insufficiency due to COVID-19. Received remdesivir, steroids, prophylactic anticoagulation, and supplemental oxygen. Discharged home medically stable.
Information was received from a physician concerning a 5 year old male who at one year of age was vaccinated SC in the leg with a 0.6 ml dose of Varicella virus vaccine.  Subsequently the patient developed break through case of herpes Zoster (date it presented was unknown).  The patient presented with a dermatome on the leg in which the vaccination was given.  Unspecified medial attention was sought.  Subsequently the patient recovered from Herpes Zoster.  A product quality complaint was not involved.  Additional information was requested. This is in follow-up to report(s) previously submitted on 5/16/2005. Information has been received from a physician concerning an 8-year-old male with no allergies or medical history and no history of chickenpox and no recent exposure to chickenpox or herpes zoster who on 13-NOV-1997 was vaccinated IM in the right thigh with a first 0.5 mL dose of VARIVAX (Merck) (lot #622852/0540E). It was noted that no rash occurred at the siteof injection or elsewhere within 42 days of the vaccination. Concomitant vacciantion on the same day included a fourth IM dose in the left leg of HIBTITER (lot # M215RD). There was no illness at the time of vaccination. Subsequently, the patient developed a break through case of herpes zoster (date it presented was unknown). The patient presented with a dermatome on the leg in which the vaccination was given. Unspecified medical attention was sought, Subsequently, the patient recovered from herpes zoster. A product quality complaint was not involved. Follow-up information was received from teh physician who indicated that on 04-FEB-2005, the patient was seen for an outbreak of herpes zoster inteh L3 dermatome of the right leg. The L3 dermatome was from the hip to the ankle. There were 50 to 75 lesions which lasted about two weeks. There was no doumented temperature. The patient's pain was rated a six to seven on a scale of one to 10, with 10 being the most pain. No diagnostic laboratory tests, including a direct fluorescent antibody, were performed and no specimens were collected for PCN analysis. The patient was reported as recovered on 08-FEB-2005. There were no adverse events following prior vaccination. No further information is expected.
Large 10cm x 5cm area of erythema on right thigh swollen and tender one day following immunization.
pt received vaccine in September and has been having arm pain from injection site to the elbow since then. She came to pharmacy 1-14-21 to let us know. She reports that her arm hurts to move up and down and to lay on it.
Watery Diarrhea,, Nausea & Vomiting:  General Weakness, All symptoms improving but  not well
THE FOLLOWING DAY AFTER MY 4TH BOOSTER, I DEVELOPED RASHES/HIVES , ITCHINESS THAT STARTED ON MY NECK AND SPREAD ALL OVER MY BODY FROM HEAD TO TOES DAILY
Menstrual Irregularities; Heavy irregular bleeding/Clotting; Period lasting longer then usual with heavy bleeding; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 13Mar2021 11:45 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); fluticasone propionate, salmeterol xinafoate (PROAIR BRONQUIAL); alprazolam (ALPRAZOLAM), Advil, and Multi Vitamins (unspecified). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, the patient experienced menstrual irregularities, heavy irregular bleeding/clotting, and "period lasting longer then usual with heavy bleeding". No treatment was given for the events. The patient was not hospitalized, or hospitalization was not prolonged due to events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Dizzy; Difficulty breathing; Diarrhea; Headache; Tired; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), HEADACHE (Headache) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (Dizzy), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 18-Mar-2021, DIZZINESS (Dizzy), DYSPNOEA (Difficulty breathing), DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were high blood pressure medicine and cholesterol medicine.
Swollen lymph nodes, sore throat,  flank pain, aching joints, dizzy, feeling faint, fatigue, back pain, diarrhea
Pt was given Shringrix at pharmacy 2 days before visit. Developed rash at site, felt headache and feverish, painful feeling in arm red and hard skin surrounding site of injection. no drainage from site no tongue swelling no dyspnea no past similar rash or reaction to vaccine No known exposure to chemicals, plants or new personal products.  Pt is doing better now
She is sick; Everything hurts; Difficulty breathing; Chest feels tight; Throat feels tight; Won't be able to get out of bed; Didn't sleep well; Muscle ache; Pain in the arm of the injection; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Didn't sleep well), PAIN (Everything hurts), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest feels tight) and THROAT TIGHTNESS (Throat feels tight) in a 34-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.     Concurrent medical conditions included Asthma.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm of the injection), HEADACHE (Headache) and NAUSEA (Nausea). On 03-Aug-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well) and MYALGIA (Muscle ache). On 04-Aug-2021, the patient experienced PAIN (Everything hurts), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest feels tight), THROAT TIGHTNESS (Throat feels tight) and MOBILITY DECREASED (Won't be able to get out of bed). On an unknown date, the patient experienced ILLNESS (She is sick). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, POOR QUALITY SLEEP (Didn't sleep well), PAIN (Everything hurts), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest feels tight), THROAT TIGHTNESS (Throat feels tight), MOBILITY DECREASED (Won't be able to get out of bed), ILLNESS (She is sick), VACCINATION SITE PAIN (Pain in the arm of the injection), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache) 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 medications included an allergy medication and a rescue inhaler for asthma.
This case was reported by a pharmacist via other and described the occurrence of injection site reaction in a 58-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination with SHINGRIX, the patient experienced injection site reaction (unspecified). The batch number of the vaccine, and vaccination date were unknown. The course of vaccination was not discontinued. It was unknown if the patient was hospitalized or the healthcare provider considered the event to be life threatening. There was no seriousness criteria involved for the event including persistent or significant disability/incapacity, death, surgical or medical intervention and conginetal anomaly.
The COVID Pfizer Bivalent vaccine was administered to patient under the age of 12 years.  No adverse effects witnessed.
pt recv vax & 2wk post vax mom reported to MD pt devel fever, myalgia & malaise;pt devel a fever of 102 & a severe local rxn on thigh @ inj site w/erythema, edema & skin tightening;pt became irritable x 3 days;
pruritic erythematous rash developed further into erythematous indurated plaque that is warm to the touch. no other symptoms.
rheumatoid arthritis; This spontaneous report was received from the patient's mother via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (the dosage regimen information was not provided) for prophylaxis.  On an unknown date (also reported as "years later"), in her 20s, the patient developed rheumatoid arthritis.  At the time of the report, the outcome of rheumatoid arthritis was unknown. No causality assessment was provided.  Upon internal review, rheumatoid arthritis was considered to be medically significant.
Severe dizziness and cloudiness; Cloudiness with a pounding headache; Severe dizziness and cloudiness; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 18:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient experienced severe dizziness and cloudiness with pounding headache. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe dizziness and cloudiness with a pounding headache was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dementia; asthma; kind of sick; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) in a 72-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 Bradycardia (patient had to be hospitalized.) in December 2019.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), ASTHMA (asthma) and ILLNESS (kind of sick). At the time of the report, DEMENTIA (dementia), ASTHMA (asthma) and ILLNESS (kind of sick) outcome was unknown.            No concomitant medication information was mentioned by reporter.  No treatment medication information was mentioned by reporter.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Developed fever up to 102 degrees around 7-8 PM, vomited 4-5 times during the night until 5-6 am, has rash to both legs. No ER/MD visit.
Patient was vaccinated with ZOSTAVAX on 5/14/13. Patient stated "the day after I got my shot my arm started turning red, swelling, and getting hot to touch." A 9.5 cm x 7 cm red whelp noted on left upper arm and warm to touch. Patient instructed to apply cool compresses to local reaction/affected area.
Received Pfizer vaccine 12/17/2020 (lot EK5730) and 1/7/2021 (lot EL0142).   Patient developed nasal congestion and headache on 3/5/2021.   PCR positive for COVID.
I noticed a rash above my left ankle on the inside of my leg on 3/30/2021 in the morning. It was red, but not itchy. On 3/31/2021, it had grown larger and redder, but still did not itch. I am treating the rash with a topical cream containing colloidal oatmeal. I am not prone to rashes or hives. The size of the rash is approximately 4 long by 2 inches deep. I have not been seen by a medical professional.
Patient's mother called 3 hours after patient received vaccine stating that patient has a fever of 101 degrees and is very cold and crying in pain.  After reporting the adverse reaction, mother stated that they would monitor patient before presenting to Dr or ER.
Fever, aches, pain started 6 hours after vaccination. Unable to sleep for the first night. Temperature was over 102 all night. Fever did not respond to ibuprofen or acetaminophen. Fever ended after 24 hours.
pain on right side of mid-abdomen and nausea - led to ultrasound and discovery of large gallstone - gallbladder removed 10/13/2021
Drive thru flu clinic -14 y/o child received adult formulation.  No phone number provided.  Mailed letter to pt to call our office to notify
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
Patient received Varicella at 10 am on 10/08/2007 started a local skin reactions at 5pm same day and fever blisters on an inflammatory background.
11-29-2017 PATIENT COMES BACK AFTER 2 WEEKS AND REPORT OF HIVES/RASH ALL OVER HIS BODY AFTER 2 HOURS RECEIVING THE SHOT. THE RASH CONTINUE FOR TOO LONG THAT HE DECIDED TO SEE HIS DOCTOR. HIS DOCTOR PUT HIM ON STEROIDS (PREDNISONE 50MG ONCE A DAY) AND TOLD HIM TO PICK IT UP 11-29-2017.
Client had one Varicella vaccine @ age 1 yr & at age 12 dx'd with chickenpox.
Cough Fatigue chills, muscle/body aches nausea  Finish Valtrex   Tylenol prn   Inc fluids / plenty of rest    Netti pot   Check COVID PCR   Rx:  Doxycycline
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' drug reactions or allergies and concomitant medications were not reported. Since December 2016, the patients might have been vaccinated with improperly stored doses of GARDASIL 9 (lot # M028323, expiry date 26-SEP-2018; route and dose were not reported). Temperature of storage was 33 F for 40 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA005775:
Have to report adverse event; 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 ADVERSE EVENT (Have to report adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Have to report adverse event). At the time of the report, ADVERSE EVENT (Have to report adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
8/25/2022 Pt received MMRV and Tdap at health clinic.  It was erroneouly not entered into system. On 9/22/2022 Pt received MMRV. He should have only received the MMR as he had a Varicella in 2018.  On 10/17/2022 He received a Tdap at clinic because when they looked in system it didn't show that he had received a Tdap on 8/25/2022.
Throat and tongue swelling that started a few minutes after the vaccine was given. No interventions were needed and the swelling subsided on its own within approx 2 hours.
Mid left upper arm swelling, mild erythema and warmth, no pain, arms feels a bit heavy and uncomfortable. No violaceous discoloration. Sites of immunization normal.
arm hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurting). At the time of the report, PAIN IN EXTREMITY (arm hurting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Weakness and pain in joints of injection arm. Later that day, stiffness and soreness and neck and shoulders. The next day, stiffness and soreness in muscles and joints, increasing throughout the day. The third day, stiffness continues, headache and toothache that does not improve with ibuprofen. Forth day, horrible headache with toothache, ear ache, muscle stiffness, body soreness, fatigue. Ibuprofen does not help.
About 12 hours after shot, began to have chills and a 102.5 fever which lasted all night. Body aches as well.  Next day was okay then 100 fever at night. The next day I had a very sore throat and very runny nose. All very similar to my prior Covid infection from January 2021, but actually worse than the actual virus.   I know ?flu like symptoms? are possible, but on day and night four now I have no smell and my sinus is exactly that of the Covid I experienced, and my throat is very sore still, making it difficult to fall asleep.   Generally feel better during the day, then fairly poor at night.
Pt vaccinated with TOPV/HIB It is not known if pt's illness was in any way related to previous vaccinations. Death cert states: bronchiolitis w/focal early bronchial pneumonia.