chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller got sick after receiving the 1st dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer Support. This is a spontaneous report from a contactable consumer (female) reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced caller got sick after receiving the 1st dose. Patient wanted to be rescheduled since her second dose will be tomorrow. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Active menstrual cycle stopped while at time of 1st dose. Cycle has not resumed to date.; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administered in left arm, administration date 09Nov2021 at 10:15 (Lot number: FF2590) at the age of 39 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: codeine, reaction: "Drug allergy". The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 09Nov2021 at 10:15, outcome "not recovered", described as "active menstrual cycle stopped while at time of 1st dose, cycle had not resumed to date". Therapeutic measures were not taken as a result of menstruation irregular.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's cycle was 21 days between an active 7 day flow. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
12-18 hours after receiving vaccine, patient called doctor and pharmacy reporting joint pain, muscle spasms, headache, nausea/vomiting, and one event of falling. Patient reported that this lasted for about 24 hours before feeling better.
sore arm; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 10:00 (Lot number: EL9265) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HPB, SVT, Hypothyroidism (all treated)" (unspecified if ongoing), notes: Treated; "HPB, SVT, Hypothyroidism (all treated)" (unspecified if ongoing), notes: Treated. Concomitant medication(s) included: FLECAINIDE ACETATE; LISINOPRIL; SYNTHROID. Past drug history included: Anesthesia, reaction(s): "Allergy", notes: no, other than nausea reactions to anesthesia. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Flecainide acetate , lisinopril, synthroid were the medications received within 2 weeks of vaccination. She was not tested positive for COVID prior to vaccination and was not tested positive post vaccination. No follow-up attempts are possible. No further information is expected.
convulsions lasting for a half hour, starting at 6 AM the day after vaccination. Per patient, venous distention in entire body.
Chest pain; blood pressure 158/96; Dizziness; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012120A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia (Rowing crew, pickleball), Tightness in chest and Shortness of breath.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96). On 08-Jul-2021, DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) had not resolved. At the time of the report, CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: negative (Negative) Left and right catheterization were all negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 8 Jul 2021 included new adverse event. On 04-Aug-2021: Significant Follow up.Dose tab is added in product tab
Patient received the Fluzone HD. Patient was under pharmacist supervision when patient stated that she felt like she was about to faint. She also stated that she has received flu shots in the past and this never happened before.
There was excursion from the freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. There was an excursion from the freezer on 01-Oct-2021 and the vaccine was administered to the patient on 25-10-2021.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15 Nov 2021 contains patient demographics, vaccine start date and dose details.
On Jan 5,2021 at 0800 fell down in parking lot due to slippery ice
Pt came back to pharmacy with a scarlet red reaction about 4-5 in long x 2 inches wide on right arm. Also arm had a bump at injection site.
My symptoms of quarter size red bump started day 2, got better the same day, worsened again day 4, then completely healed by day 5.  Then I developed "covid arm" day 8 of a softball size red itchy swollen area over injection site.  .  Just treated with otc antihistamines and cortisone cream.
Rash at the injection site. Also chills, aches, etc. Received the second shot in the same arm as the first but did not have a rash the first time.
Unable to receive 2nd dose- is in another country; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country) in a 57-year-old female patient who received mRNA-1273 (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country). On 30-Apr-2021, PRODUCT ADMINISTRATION INTERRUPTED (Unable to receive 2nd dose- is in another country) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No treatment medication was provided  No concomitant medication was provided
Mother states patient with no fever. Mother states patient has been nauseated & vomiting since receiving flu shot yesterday. States vomiting blood. Informed to see PCP ASAP - not normal adverse reaction & might be other cause.
This case was reported by the mother of a consumer and described the occurrence of hive-like rash in a 3-year-old male subject who was vaccinated with Dtap vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. There were no concurrent medications. In June 2004 the subject received unspecified dose of Dtap vaccine in an unknown arm. In June 2004, immediately after vaccination with Dtap vaccine, the subject experienced a hive-like rash that began to crawl up his neck and face and he experienced a scratchy throat. At the time of reporting the events were resolved. It was noted that two years ago, this subject was given a tetanus booster (unspecified) without any such side effects. It was noted that the dose of Dtap vaccine given was the second of it's kind in the childhood immunization series.
can still get a mild case of shingles after getting the vaccine.Suspected Vaccination failure; mild case of shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, unfortunately you could still get a mild case of shingles after getting vaccine. The patient did and his/her said that, you could get them more than once. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR096305, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR096305:same reporter
24 hrs after injection fever, local redness/induration at injection 4x6cm.
hearing loss; This spontaneous case was reported by a pharmacist and describes the occurrence of DEAFNESS (hearing loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss) had not resolved.        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 medication was reported. Treatment drug information was not given.  The consumer received the first dose of the Moderna Covid-19 vaccine on 06Jun2021 and experienced hearing loss that was still ongoing.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (severe stomach pain) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029120A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, SIMVASTATIN for Cholesterol.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (severe stomach pain). On 24-Jan-2021, ABDOMINAL PAIN UPPER (severe stomach pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took second dose on 03Mar2021 (Lot no :013A21A) left arm. treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Patient demographic was added or updated, vaccine information was added, concomitant medications was added
Pt started fainting few minutes after getting vaccine. She was light pale, and also complaint of shortness of breath. Patient received EpiPen. She was sitted, and was given water. She felt better by the  time ambulance came in, but was taken to the ER for evaluation.
AUTOIMMUNE DISORDER; This spontaneous report received from a patient via a company representative through a social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced autoimmune disorder. The reported stated that " Your j and j Covid vaccine caused my autoimmune disorder, how about we start researching that". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autoimmune disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221210426-autoimmune disorder. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Case number PHEH2014US025360, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 59 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 20 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
right after reaction got throat tightness and weird feeling on back of tongue.  Was given 50mg IV benadryl to treat and it went away
TINNITUS - NOTED RINGING IN EARS BUT ATTRIBUTED TO POSSIBLE ALLERGIES (EVEN THOUGH IT WAS NOT NORMAL TIMING.)  A FEW DAYS AFTER RECEIVING MY SECOND VACCINATION ON 09/08/2021 I NOTED THE RINGING HAD INTENSIFIED.  STILL DID NOT ATTRIBUTE TO A REACTION OF THE VACCINE, BUT DID NOTE THE TIMING WAS CLOSELY RELATED TO DATES OF VACCINE ADMINISTRATION.
This spontaneous report as received from a physician via company representative refers to a 70 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiry date unknown) injection, one shot. There was no concomitant medication. On an unknown date, the patient experienced shingles within a couple of weeks after receiving ZOSTAVAX. Patient sought medical attention and visited office. There was no product quality complaint. Treatment information was unspecified by the reporter. The patient recovered from the event after stopping the therapy. Additional information is not expected.
Patient received injection with no vaccine in it, was empty with just air. Pt showed no symptoms of adverse events, this is just a report of error in administration. He was then administered a dose of the vaccine separated by a couple of inches from the location of the original injection of air.
Patient was administered a dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-366918, MOD-2021-365600, MOD-2021-365692, MOD-2021-365742, MOD-2021-365891, MOD-2021-366043, MOD-2021-366226, MOD-2021-366595, MOD-2021-366925 (Patient Link).
1st 48 hrs after shot left arm swelling at injection site area upper arm, as well as swelling on undersurface of upper arm down to elbow, tenderness in anterior axillary area. 4 days after shot swelling is resolved, mild tenderness in anterior axillary area.
Patient received GARDASIL injection, within 5 minutes she attempted to get up from table, walked to chair and sat down and fainted. Patient was semi aroused moved back to table to lie down, BP was 110/70. Patient continued to be semiconscious for several more minutes.
does not feel that good; low grade fever; Fever; arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is hurting), FEELING ABNORMAL (does not feel that good), PYREXIA (Fever) and PYREXIA (low grade fever) in a 38-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is hurting). On 18-Apr-2021, the patient experienced PYREXIA (Fever). On 19-Apr-2021, the patient experienced FEELING ABNORMAL (does not feel that good) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (arm is hurting), FEELING ABNORMAL (does not feel that good), PYREXIA (Fever) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was provided. Action taken with mRNA-1273 in response to the event was unknown
Red swollen, itching and very sore to touch at injection site. Aching all over.  Fatigue
Initial report received from a healthcare professional on 15 Jan 2010: This polymedicated patient had a medical history of type II diabetes, hypertension (HTN), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), gastro-esophageal reflux disease (GERD), hyperlipidemia, anemia, Parkinson's disease, gout, renal insufficiency and psoriasis. The patient had received influenza vaccine in past season without any adverse event. The patient vaccinated with FLUVIRIN  (lot number: 102132P1) on 13 Jan 2010. Following FLUVIRIN administration, the patient experienced a seizure, with a latency of 4 hours and hospitalized. The patient had no history of seizure or epilepsy. An electro-encephalogram (EEG)  after the seizure showed no epileptic activity. The patient was on a ventilator in the intensive care unit and was treated with antiepileptic medications and antibiotics because of possible aspiration during the seizure. The patient was sedated and did not return to baseline mental status since the seizure. Outcome of the events was reported as condition unchanged. Follow up report received on 23 Apr 2010: Two requests for follow-up information were sent on 09 Feb 2010 and 29 Mar 2010 respectively, but no reply had been received. Hence the case was closed due to the lack of response.
1 day after vaccine arm was slightly sore, but changed  to moderate itching only around injection site. Arm was red about 4 inch diameter, warm to the touch and felt hard under the skin. As of today, 3/1/2021, 10:30 am, the area continues to itch and is still warm and hard under the skin.
Patient received vaccine and was told to stay seated. Patient stood up and experienced syncope.  Patient hit head on floor of exam remove and was take to area hospital ED for evaluation. Patient sustained mild concussion.
Excruciating pain in the wrists of both hands. The index finger of my left hand has been turning purple for a month, I feel as if something is bursting inside and it hurts for several days, it returns to normal for a couple of days and the same thing happens.
Local Swelling/Redness at injection site. Pt complained of soreness and reduced range of motion.
Information has been received from a consumer concerning a stranger's granddaughter who was vaccinated with MMR II (lot number, route and site not reported). After receiving the vaccination, the patient was diagnosed with autism. The outcome was unknown. This is one of several reports received from the same source. Upon internal review, autism was determined to be an other important medical event. No further information is available.