chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED FLU VACCINE AND ABOUT 4 HOURS LATER BROKE OUT IN HIVES.  PATIENT CAME TO CLINIC.  PATIENT CONTACTED PRIVATE PROVIDER AND WAS ADVISED TO GIVE CHILD BENADRYL AND CONTACT OUR OFFICE TO COMPLETE VAERS.
Febrile seizure 5 hours after receiving 6 total immunizations. Seizure lasted 15-20 min and was stopped w/ VERSED. Temperature > 102 degrees F measured in ambulance.
Immediate rash appeared around injection site, and some itching was reported. The patient took Benadryl after she got home, and when I checked on her at 5pm, she said it was "much better".
itchy, red splotches, hives, prickly sensation on skin on date of injection, then came back on Saturday evening 1/23
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended. On or about 01-MAY-2016 the patient was treated at a medical group and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. Additional information has been requested.
It was reported that a 27-year-old female patient received a TD Adult vaccination on 3/17/01. Reportedly on 3/18/01, the patietn woke up at 4am with chills, fever 102F, generalized body aches, dizziness and nausea. Advised to go to emergency room per physician. Treated with IV fluids for dehydration. Antipyretics for fever. On 3/19/01 patient developed local reaction of redness and swelling of injection site with soreness, took Motrin. Also felt an enlarged lymph node. Physician instructed patient to continue on Motrin and to be evaluated if enlarged lymph node persists in 4 weeks. From additional correspondence received on 4/25/01, it was reported that the patient was treated symptomatically with analgesics, rest and IV fluids in the emergency room. Additional patient information was also provided.
Fever, chills, nausea, HA started about 24 hours after receiving flu shot. Seen in ER. Labs checked. Pain meds for HA administered. Had rash 1 wk later lasting several days. Pt slowly improving, but continues with nausea, decreased appetite, oliguric.
24 hours after vaccination.  Patient felt a fullness all over and discomfort.  She had a low grade temperature with aches all over body left and right.  I&R on left side of body.  Symptoms subsided by 05/25/2005.
Per report from LPN monitoring patient--complaining of chest tightness and anxiety.  02 sat 99, Pulse 67, BP 114/83 and repeated at 126/94.  Monitored for 30 minutes, patient continued to report symptoms.  Monitored for additional 15 minutes.  Patient left clinic with improvement in symptoms.
A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. Expired FLUMIST QUADRIVALENT was administered to two patients which started on 24-Oct-2014. The outcome of the event of expired FLUMIST QUADRIVALENT administered to two patients is unknown. The report was considered to be non-serious.
Stuffy nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and HEADACHE (Headache). On 25-Jan-2021, NASAL CONGESTION (Stuffy nose) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
VACCINE was given by local rite aid.  about 8 hours after given, developed higher heart rate and feeling that she had 'sand' in her lungs and felt harder to breathe.  has felt fatigued.  slight headache. no fevers (99.1 in office). Seen in office and heartrate varied from 107 to 120, normal respiratory rate and normal pulse ox. Normal lung and cardiac exam other than heart rate. Advised fluids, rest and ibuprofen and close monitoring for now,
Little sick; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Little sick) and COVID-19 (COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MALAISE (Little sick) and COVID-19 (COVID-19). At the time of the report, MALAISE (Little sick) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, SARS-CoV-2 test: positive positive Positive.         The concomitant medications were not provided.The treatment information was not provided.  The action taken for mRNA1273 with the events were considered as not applicable.
Fever up to 100.9 on the day after administration that persisted for 8 hours.  Then headache started on the day after vaccine administration and persisted for 8 hours.  Arm was sore starting the day after vaccination and persisted for 3 days.  Patient lost her appetite on the day after vaccination and this persisted for 3 days.  Patient experienced aches/pains (as though she was coming down with the flu) on the day after vaccine administration and this also persisted for 3 days.  All symptoms by 72 hours.
Extreme fatigue within a week or two. Assumed it was work related. A month later I started waking up and arms felt tingly or numb. Arm pain increased, so I made an appointment with my doctor and have started running tests to find out why the pain is increasing and how to correct it.
Client states evening of 4/13/18 extreme pain/tenderness began in upper arm area where vaccine give. By the next morning (4/14/18) client was unable to move/use arm and noticed red blotches around injection site, swelling of arm from shoulder to elbow, and red streaks from shoulder moving down to elbow. Client states that on 4/16/18 she had continued pain and tenderness of arm as well as red "blotches" and swelling, and some mobility had returned to arm. On 4/16/18 client states that swelling has improved and she now has full use of arm. Slight redness in area, but much improved.
Initial unsolicited report received from a non-health care professional on 19 January 2016. This case involves a male patient (age unknown) who was vaccinated with a dose of Influenza vaccine (batch number, expiry date, route and site of administration were not reported) on an unspecified date (reported that he received the vaccine "this year"). Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu A. It was reported that the patient saw the doctor. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: Flu A. List of documents held by sender: none.
Client reported she felt tingling sensation in lips and also reported felling like her lips were beginning to swell.  Had history of use of epi pen for allergies approx 12.:14 reportedly felt flushed.  No difficulty with breathing.  Benadryl  50 mg elixer given.  Observed an additional 15-20 minutes.  Client reported feeling better within 20 minutes and all symptoms resolved.  Case's boyfriend was also recieving vaccination that day.  Client was advised not to drive home since administration of antihistimane.  Departed with boyfriend. Also advised to call medical provider to inform of side effects. Instructed may take benadryl 50 mg po q 6 hours if needed and call 911 if symptoms worsen.  Contacted client 6:30 today.  She reported she notified physician.  Symptoms resolved except for slight soreness at injection site.
Burning sensation during injection at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning sensation during injection at injection site) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Burning sensation during injection at injection site). At the time of the report, VACCINATION SITE PAIN (Burning sensation during injection at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication and treatment information was provided.
no additional AE; temperature excursion involving Pneumovax 23 was administrated to 2 patients; Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no information regarding to the patient's pertinent medical history, concomitant medications, or drug reactions/allergies provided.  On 02-FEB-2021, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T031820, expiration date 10-MAY-2022 for prophylaxis; dose and route were not provided), which involved a temperature excursion. The vaccine was stored at temperature of 47.7 Fahrenheit degree for 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No other adverse effect was reported. There was no product quality complaint involved in this case. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the second of the three reports.  A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021148567 same drug and event, different patient;US-PFIZER INC-2021148508 same drug and event, different patient
menstrual pain has been magnified; her period came one week early; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (age: 45; unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 21Dec2020 to 21Dec2020 as SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The reporter/patient is an RN that got vaccinated with the first dose of the COVID vaccine in the 21Dec2020. According to her she had nothing different aside that and her period came one week early, and the menstrual pain has been magnified. She wonders if the vaccine could have caused this. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Patient passed out 3 minutes after being given the last immunization, she complained of light-headed, and nausea before passing out. Patient was assisted to the ground and 911 was called. Patient had consistent pulse and was breathing the entire interaction.
I had a sore throat headache, low-grade fever of 100.2, cough, and congestion. I tested positive for COVID-19 at home and then went to a COVID-19 testing site to get tested again and it was positive. My doctor prescribed PAXLOVID and started to get better.
Presented to emergency department at ancillary facility on 3/19/21 with shortness of breath and was admitted at that time.  He was transferred to regional medical facility on 3/23/21 for further management due to increasing oxygen requirements and worsening congestion.  Patient was discharged on 4/2/21 to rehab facility.  Patient presented to emergency department on 4/12/21 from rehab facility for worsening hypoxia and respiratory failure.  Chest xray showed new infiltrates and he was started on antibiotics for pneumonia. He was discharged on 4/20/21 to a skilled nursing facility.
This spontaneous report as received from a registered nurse refers to a 4 year old patient of an unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PROQUAD (dose, lot# expiration date and route of administration were not reported). On 08-AUG-2016, the patient was vaccinated with the second dose of PROQUAD lot # M015700 with expiration date: 26-SEP-2107 (dose and route of administration were not reported) that was improperly stored. Administered dose of PROQUAD underwent excursions at -12.8 degrees Celsius, for 66 hours and 15 minutes. There was not previous temperature excursion. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Pt devel polyarthralgia following vax w/rubella vax; dx of rheumatic fever & strep infect were r/o;
headache Subarachnoid hemorrhage (HCC) Focal hemorrhagic contusion of cerebrum (HCC)
pt recvd vax;fever,fussy;would not settle down to sleep;apap given;pt became stiff,jerked;did not awaken but no LOC;mom reported to MD, pt eating & playing now;
Fever, chills, fatigue - lasted for 12 hours after administration. Patient took TYLENOL twice.
Squamous Basal Cell tumor discovered on Vocal Cord, following hoarseness complaint after receiving vaccine.  Final diagnosis made 8/19/2021 after biopsy procedure.  Referred to Cancer Center for treatment.  Treatment consisted of 7 weeks of radiation therapy with 5 chemotherapy sessions (Cisplatin).  Active treatments completed on 12/16/2021.  Final outcome to be determined on 3/17/2022 via PET Scan.  (Item 19 ctd) Laryngoscopy date: 9/07/2021   Initial PET Scan: 10/15/2021.  Radiation Tx: 10/28/2021 - 12/16/2021.  Chemotherapy: 11/03/2021 - 12/15/2021.
Patient received expired vaccine. Expired 3/26, received 3/30. No adverse effects. Patient will not see revaccination.
lt arm was swollen from site of inj down to wrist;about size of an eggplant;accompanied by extreme pain;T101;
red injection site reaction; bumpy injection site reaction; pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced administration site reaction below the injection site on her left arm after getting her first Shingrix dose.  The pharmacist described the reaction as red, bumpy and that patient told her it hurt to touch the area.
48 hrs p/vax pt devel stiff neck; shot given on 15NOv; still c/o stiff neck on 21NOv; states pt was in bed over weekend w/nausea & general malaise;
Rt arm swollen, tender, warm @ site, pt is cranky; spot is about 2in in diameter; Redness slowly spreaded; Pt refuses to move arm;
Sore arm and tiredness the the day after and 2 days following the vaccine.  Severe headache continuously ongoing since 4/9/21 and fatigue.
pt recv 2 doses of vax & 20JUN96 pt exp a low titer level of 0.09;
Heart started beating very rapidly; Raised blood pressure; Sore arm; Head started to hurt; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Head started to hurt). On 23-Jan-2021, HEART RATE INCREASED (Heart started beating very rapidly), BLOOD PRESSURE INCREASED (Raised blood pressure) and HEADACHE (Head started to hurt) had resolved. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: After vaccine:136/104  Her normal BP:124/72. On an unknown date, Heart rate: 130 130 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were mentioned.
Reports fatigue day after (1/28/21) 2nd dose.  No missed work
Severe chills, fatigue, headache, nausea, strong arm pain. Similar sensation to having 40 C fever, but I had 37.
headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (tired) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications reported included Blood pressure medication(not specified).
he gets his second dose his arms pop all the time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "he gets his second dose his arms pop all the time".  The lot number for bnt162b2 was not provided and will be requested during follow up.
now chilly and then warm; Itching; tired; Worst case of hives the doctor had ever seen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Worst case of hives the doctor had ever seen) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced URTICARIA (Worst case of hives the doctor had ever seen) (seriousness criterion medically significant). On 24-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (now chilly and then warm), PRURITUS (Itching) and FATIGUE (tired). At the time of the report, URTICARIA (Worst case of hives the doctor had ever seen) had resolved and FEELING OF BODY TEMPERATURE CHANGE (now chilly and then warm), PRURITUS (Itching) and FATIGUE (tired) 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 concomitant medications were provided Treatment medications included were intravenous drip( IV), prednisone, diphenhydramine, famotidine and was given epinephrine pen on discharge, just in case needed to use it(has not used it).  Company comment: 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.; 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.