chrisvoncsefalvay/vaers-outcomes huggingface dataset:
With both doses soreness in the left arm.; mild fever; general achiness; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at arm left (at the age of 43-year-old) on 20Feb2021 10:00 (Lot Number: EL9264) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient did not have COVID prior vaccination. The patient had not tested COVID post vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration at arm left (at the age of 43-year-old) on 30Jan2021 15:00 (Lot Number: EN9581) as single dose for COVID-19 immunisation and experienced soreness in left arm. The patient with both doses had soreness in the left arm and after the second dose had mild fever and general achiness on 21Feb2021 02:00 (AM). The patient did not received treatment for events. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
I started having symptoms of COVID-19 and tested positive. It started as an itchy throat, and I had a temp the next morning and a headache. It was then just nasal congestion like a bad cold. I called my PCP and she recommend Paxlovid. It was a large, awful pill and I did not get any rebound. It hopefully helped. Taking the pills messed up my taste buds I tested negative by the sixth day.
This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 65-year-old male patient who received TWINRIX adult. Co-suspect products included TWINRIX adult, TWINRIX adult and TWINRIX adult. On an unknown date, the patient received the 1st dose of TWINRIX adult 1 ml, the 2nd dose of TWINRIX adult, the 3rd dose of TWINRIX adult and the 4th dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, TWINRIX adult and TWINRIX adult and not applicable after receiving TWINRIX adult, the patient experienced therapy non-responder and incomplete course of vaccination. On an unknown date, the outcome of the therapy non-responder and incomplete course of vaccination were unknown. It was unknown if the reporter considered the therapy non-responder to be related to TWINRIX adult, TWINRIX adult and TWINRIX adult. Additional details provided were as follows: On unspecified dates, the patient received 3 doses of TWINRIX adult vaccine as per accelerated vaccination schedule and never came back to receive the booster dose schedule after a year of receiving the 3rd dose. This led to an incomplete course of vaccination. On an unknown date, the patient underwent serology test and was tested non-reactive for the titres as recommended by the health care professional. The reporter wanted to know, whether they need to repeat the vaccination with TWINRIX or only with the Hepatitis B vaccine. No side effects were reported. Age at vaccination was not provided.
RED LUMP ON ARM; RED MARK ON ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included leg pain, and other pre-existing medical conditions included the patient had received flue shot in the past but past reaction was not red. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 12:30 at right deltoid for prophylactic vaccination. Concomitant medications included ibuprofen for leg pain. On 31-MAR-2021, the subject experienced red lump on arm. On 31-MAR-2021, the subject experienced red mark on arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red lump on arm, and red mark on arm. This report was non-serious.
Oral swelling , itching ,right side facial drooping. Taken to ER by staff in wheelchair
Extremely weak; numbness in my legs, arms, face including my tongue; numbness in my legs, arms, face including my tongue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue) 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 ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue). At the time of the report, ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
One week after vaccine my daughter came down with a low grade fever followed by a rash over her entire body. Two days later she had breathing issues and was gasping in her car seat.
From about a week since the second dose of the vaccine, I have been experiencing episodes of vertigo/dizziness and an increase in asthma symptoms
pt recv vax & pt failed to seroconvert w/a 0.0 titer (EIA);it was noted that pt had responded to other vax including hep b vax & MMR;
Developed fever to 101.4 F, chills, severe muscle aches, headache and fatigue beginning during the night after the 2nd dose. Symptoms lasted 24 hours.  Also local site pain, swelling and warmth for 3 days following injection.
This spontaneous report as received from a medical assistant refers to a 67 year old male physician. On 05-DEC-2013 a patient was vaccinated with VAQTA (lot number reported a J011712; expiry date 21-SEP-2015). No concomitant medications were reported. On 05-DEC-2013, while finishing administering VAQTA dose to an anonymous patient with a VAQTA prefilled syringe, the barrel of the syringe broke. No unusual force was exerted on the syringe and the patient was behaving. The breakage happened just as the dose was finished being injected, but before the syringe needle was removed from the patient. The patient did receive the full dose of VAQTA. No known adverse effects to the patient. The broken glass of the syringe made a 3/8th inch cut on the physician's middle finger of his right hand. The physician was not sure if some VAQTA got into the cut. The physician washed out the cut but the cut was still bleeding. PQC was filed for the broken VAQTA prefilled syringe. No treatment was provided for the event. The physician did not sought medical attention. The outcome of the event cut in the middle finger and bleeding was not recovered. Additional information has been requested.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored PEDVAXHIB (lot#, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. here for well check 9:10 AM appt. She had not eaten or drank anything that morning. Had blood draw also. Lightheaded after shot/blood draw - pt laid down, given juice. Seemed fine when left clinic then fainted when getting out of elevator. Returned to clinic - vitals stable - observed, given food and juice - pt. recovered.
much heavier menstruel cycle with large clots cycle now lasts twice as long  low blood pressue (75/45)  treatment- constant hydration required to maintain blood volume treatment- supplementing with iron
A 37 year old female patient experienced mild soreness, injection site soreness, fatigue, fever, chills, aching in gut around the liver and kidney areas, decrease in blood pressure and nausea while being treated with RabAvert intramuscularly for a dog bite. No significant medical history. Additional medications included a tetanus shot (with first dose) and rabbies immune globulin (with second dose). The patient experienced mild soreness, injection site soreness and fatigue following the first dose of RabAvert. Reportedly, the symptoms increased in intensity after the initial 24 hours and she experienced fever, chills and aching in her gut around the liver and kidney areas. The fever reached 101.4 degrees. Patient stated she had a decrease in blood pressure as evidenced by a feeling of vomiting and nausea when she got up to answer the door. Symptoms resolved after lying on her back for 15 minutes. A tetanus shot was given with the first dose of RabAvert and human rabies immune globulin was given with the second dose of RabAvert. Patient reported no symptoms following the second dose of RabAvert and that all of the symptoms have received. She decided to not complete the Rabivert series because the dog that bit her was not exhibiting any signs of rabies.
flu shot doesn't work, and that father died within 24 hours of getting the flu shot; Initial information received on 31-Aug-2023 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who died within 24 hours of getting the flu shot, while receiving vaccines Influenza Vaccine and Covid-19 Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (formulation, strength: unknown) (lot number, Expiry date: not reported) and suspect Covid-19 Vaccine not produced by Sanofi Pasteur (formulation, strength, lot number, Expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the flu shot doesn't work and patient died within 24 hours of getting the flu shot (sudden death) following the administration of Influenza Vaccine and Covid-19 Vaccine.   Final diagnosis was (fatal) flu shot doesn't work, and that father died within 24 hours of getting the flu shot.  No lab date reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Fatal for the event.  No autopsy was done. The cause of death was reported as Sudden Death.  Seriousness Criteria: This event was assessed as medically significant and was leading to death.; Sender's Comments: Sanofi company comment dated 05-Sep-2023: This case involves an unknown age male patient "who died within 24 hours of getting the flu shot", while receiving vaccines Influenza Vaccine. Furthermore, information regarding condition at the time of vaccination, medical history, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, autopsy details would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.; Reported Cause(s) of Death: flu shot doesn't work, and that father died within 24 hours of getting the flu shot
2/5/23   I did not sleep all night. I became very congested and had trouble breathing. The next morning, I took an at home COVID test which was positive.  I went to pharmacy and had a positive test. I was unable to see a doctor. I called my PCP and was prescribed an antibiotic, not sure of name, and prednisone. I took the prednisone for 2 days and was unable to urinate, so I stopped it.  I finished the antibiotic. I was told not to take a decongestant because of my Losartan. I called my PCP back and told them I was miserable with congestion. I was told I could take one dose here and there of Alka Seltzer Cold. It ran its course. I was very tired, which remained.  I started feeling tinnitus in my ear. I went back to my PCP and had ear wax removed. The tinnitus continued.  The Allergist approved blood test to see what I was allergic to.  The bloodwork revealed I was allergic to dust mites which I am taking allergy shots for.  I saw an ENT doctor on 3/10/23 who prescribed two weeks of antibiotic because I had an infection in my nose.  I saw a different ENT doctor last week and had a hearing test and was told I had hearing loss.  I have a CT of my sinuses is scheduled next week.
Pt states rash developed on trunk, arms & head itches since 1 day post receiving GARDASIL #1.  Rash is lessening but still has it.  Denies HA of fever.  Has not taken any rx.
After I took my bandage off, I noticed a great big round red spot on my arm, and it was hot to touch. I felt a little tired and achy, like I was coming down with the flu, but I was ok. I called my doctor because I was worried about anaphylactic shock, but my doctor assured me that I was ok. They told me that if I started having trouble breathing to go to the emergency room.  They told me to use Benadryl cream, and take Zyrtec as needed.
24 hours after receiving the first dose of covid vaccine, I started having a really bad headache that I could not get rid of even with taking 1000mg of tylenol
Pt complained of pain 2.5-3 hrs after inj. Went to dr on 12-6-16, Dr stated arthritis was triggered in shoulder, was given cortisone shot. Pt states still has limited range of motion.
being hot; sweaty; weird taste in mouth; A spontaneous report was received from a nurse concerning a 54-year-old, female patient and who experienced being hot, sweaty and a weird taste in her mouth.  The patient's medical history included high blood pressure and a positive Covid-19 test on 28-Dec-2020. Products known to have been used by the patient, within two weeks prior to the event, included birth control and high blood pressure medication.    The patient received their first of two planned doses of mRNA-1273 (LOT # 011J20A) on 26-Dec-2020 intramuscularly in the right arm for prophylaxis of COVID-19 infection.  Patient stated that she received the Moderna vaccine on 26-Dec-2020.  She had a negative Covid-19 test on 24-Dec-2020 and was asymptomatic prior to vaccine administration.  After she received the vaccine, patient reported being hot, sweaty and had a weird taste in her mouth.  Additionally, she reported a positive Covid-19 test on 28-Dec-2020.  She was in quarantine for 10 days.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, being hot, sweaty and weird taste in mouth, was not provided.  The outcome of the events, being hot, sweaty and weird taste in mouth, was not reported   The reporter did not provide an assessment for the events, being hot, sweaty and weird taste in mouth.; Reporter's Comments: This case concerns a 54-year-old, female, patient, who experienced non-serious unexpected events of Feeling hot, hyperhidrosis and taste disorder. The events occurred after receiving first dose of mRNA-1273, lot # 011J20A. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient reporting being Covid-19 positive after vaccination is considered a confounder.
He developed profuse sweating, his eyes got really itchy, and he felt like his face was getting swollen.  He had no hives and no trouble breathing.  I had him take Benadryl. He did fine.
Headache; Felt cold and hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot). On 12-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot) and HEADACHE (Headache) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-006025 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-006025:
It was reported that a 20 year old female received a Menomune A/C/Y/W-135, a Typhim VI and an IPOL vaccination on 4/19/00. Reportedly, about 4-5 hours, post vax, the pt developed red, swollen and itchy eyes. This resolved fully with antihistamine. No further information is anticipated for this report. The case is closed.
Pronounced headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 09:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 09:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 11:15, approximately two hours after second dose of injection, the patient experienced pronounced headache. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event pronounced headache was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed a DVT in left calf that resulted in multiple pulmonary embolisms; patient complained of shortness of breath x 2 weeks and presented with a swollen and discolored lower leg.  X-rays and scans confirmed DVT and PE's.  Patient underwent thrombectomy and was on Heparin drip followed by Eliquis at home.  Patient discharged from ICU after 3 days.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (003110). An adult patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient had fatigue and sight disability (can't hardly keep our eyes open), onset 2021, with outcome of not recovered. Follow-up attempts completed. No further information expected. Sender's comments: Linked reports: US-PFIZER INC-202101155279 same reporter/AE/SD, different patient; US-PFIZER INC-202101155391 same reporter/AE/SD, different patient.
Irregular cycle my period came 10 days early and very painful; Irregular cycle my period came 10 days early and very painful; Irregular cycle my period came 10 days early and very painful; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Sep2021 (Lot number: EW0172) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= ER8737, prev dose lot unknown=False, administrator route=Intramuscular, prev dose administration date=30Aug2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 30Aug2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: MENSTRUATION IRREGULAR (non-serious), POLYMENORRHOEA (non-serious), DYSMENORRHOEA (non-serious) all with onset 11Oct2021, outcome "unknown" and all described as "Irregular cycle my period came 10 days early and very painful". It was unknown if therapeutic measures were taken as a result of menstruation irregular, polymenorrhoea, dysmenorrhoea.  No follow-up attempts are possible. No further information is expected.
The patient presented with acute onset of left arm weakness 4 days after vaccination. It progressed to significant weakness within a week and she was found to have acute central demyelination on MRI.
Moderna COVID-19 Vaccine EUA dose given 65 days after BUD for refrigeration
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: BP 117/74 HR 62, second reading 122/111 HR 64, 3rd reading 142/81 HR 63. Patient was loss consciousness within 3 minutes of vaccine. I called the paramedics but he regained consciousness after 1 minute so we cancelled the call. He continued to complain of feeling dizzy so I had him stay for an additional 15 minutes. He has history of fainting with IVs/blood draws.
Three days after the vaccine she had a rash that covered 50% of her body. It was blotchy and dark pink. She is non-verbal so we do not know if it was uncomfortable, but she did not scratch at it and seemed otherwise perfectly healthy (no fever or other symptoms). The rash came and went over 48 hours over various parts of her body, definitely lighter and less on the second day before going away completely.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about concomitant medications and pertinent medical history reported. On an unknown date, at the physician's office the patient was vaccinated with dose of ZOSTAVAX dose, route, lot #, expiration date were not provided. On an unknown dates, after administration of ZOSTAVAX, the patient experienced shingles an unspecified number of times. The patient sought medical attention from physician and received as a treatment of shingles unspecified anti-viral medication, on unknown date. The outcome of event was reported as not recovered/not resolved from current diagnosis of shingles. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Pt ran a fever of 102.7 the day after he receive vaccine. Temperatures stayed for 3 days. On 1/30/06 child came to see MD, fever was 101.