chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe hives (weeping), onset 48-hours post-injection. Lasted 11-days.; This is a spontaneous report from a contactable consumer, the patient. A 64-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 right arm on 29Mar2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 14:00 the patient experienced Severe hives (weeping), onset 48-hours post-injection. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event hives was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Severe headache started 7pm on April 6th, and remained severe until 9pm on April 7th.  Violent vomiting started at 6am on April 7th and ended at 9pm on April 7th. I could not even keep sips of water down
Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died due to a heart attack.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included additional medications.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  - On an unknown date, the reporter stated the patient received Moderna's COVID-19 vaccine and sometime after he was found dead by his bedside around 02:30 am.   The patient died on an unknown date. The cause of death was due to a heart attack. Plans for autopsy were not provided.; Reporter's Comments: This case concerns a 56 year old, male patient, who experienced fatal unexpected event of myocardial infarction. The event occurred on an unspecified date after mRNA-1273 (Lot# Unknown). Treatment details not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death
One to two months after receiving the second dose of varicella virus vaccine live, a serum antibody test revealed that the pt had not seroconverted.
Severe Migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe Migraines) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MIGRAINE (Severe Migraines). At the time of the report, MIGRAINE (Severe Migraines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: 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.; Reporter'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.
extreme fatigue; malaise; chills; fever; nausea; diarrhea; muscle aches; headaches; This is a spontaneous report from a contactable physician, the patient. A 43-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8727) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Mar2021, the patient experienced one week of extreme fatigue, malaise, chills, fever, nausea, diarrhea, muscle aches and headaches. No therapeutic measures were taken as a result of the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, malaise, chills, fever, nausea, headaches, diarrhea and muscle aches was not recovered at the time of this report.     No follow-up attempts are needed. No further information is expected.
1 day following MMR and IPV right thigh and DTaP left thigh, pt. developed redness over right anterior thigh; no other symptoms on exam, 6x9 cm red splotchy rash over vaccine zone.
Initial information received on 30-Aug-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient (age not reported) who experienced left eye is irritated, when he snapped the cap off a prefilled syringe of FLUZONE HIGH DOSE, he was splashed with fluid in his left eye on an unspecified date. The patients past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was an occupational exposure case due to accidental occupational exposure to product and medication error case due to exposure via eye contact and the only symptom he reported was his left eye was irritated (date not reported). He administered the FLUZONE after the incident. It was not reported if any lab investigations were performed or any corrective treatment was received. Final diagnosis was left eye is irritated. It was not reported if the patient received any corrective treatment. The outcome of left eye irritation was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Fever 100.2-100.3F; chills/rigors; left arm pain; Fever >101F; chills/rigors,; night sweats; myalgias; right arm pain; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.    The patient's past medical history included COVID-19 from 23-Jan-2021 to 13-Feb-2021.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain). On 31-Mar-2021, the patient experienced PYREXIA (Fever 100.2-100.3F), CHILLS (chills/rigors) and INJECTION SITE PAIN (left arm pain). On 06-Mar-2021, PYREXIA (Fever >101F), CHILLS (chills/rigors,), NIGHT SWEATS (night sweats), MYALGIA (myalgias) and INJECTION SITE PAIN (right arm pain) had resolved. On 02-Apr-2021, PYREXIA (Fever 100.2-100.3F), CHILLS (chills/rigors) and INJECTION SITE PAIN (left arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treated with over the counter NSAID (Motrin and Tylenol).   This case was linked to MOD-2021-035957 (Patient Link).
32 year old developed CP and palpitations after smallpox (1 week) vaccination. Reported this after cardiac events reported. W/U - ECG, CXR, Eifro - WNL, LOL-144, increased triglycerides, positive hx HTN, increased lipids, ETT-clinically negative, EKG positive. Cath-clean, arteries and good liver function. Cleared by cardiology.
Patient experienced adverse allergic reaction to vaccine consisting of hives, itching, and swelling face and lips.
pt recvd vax & devel unspecified react; pt recovered; No further details were provided
Information has been received from a physician concerning a 9-year-old female with no pertinent medical history or allergies who on 07-APR-2003 was vaccinated subcutaneous in the left arm with varicella virus vaccine live (Oka/Merck) (Lot # 641148/0791M). Concomitant vaccine included a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 644644/1080M) administered on 07-APR-2003. On 04-SEP-2007, the patient developed 5 vesicles/15 papules on her arms, legs, scalp and axilla that was treated with Benadryl and calamine lotion per physician. The patient sought medical attention via a doctor visit. No diagnostic labs were performed. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
After receiving pfizer vaccine (about 10 minutes) pt complained of numbness, tingling with fullness in her throat. She was given epi-0mg in left deltoid area.  Paramedics were called in. Pt continued to complain of her tongue tingling and swelling and benadryl 50 mg administered IM. Paramedics arrived and started IV and transported her to ER.  Pulse ox was 87% on room air, HR 98 and BP 157/77.
She said her HCP told her she could do a different one for her second; feeling that she was very ill; lethargic/ feeling lethargic and could not get out of bed; lightheaded; nauseated; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 03Feb2021within 4-5h after the vaccination, the patient felt patient that she was very ill, lethargic and could not get out of bed, lightheaded, nauseated and she would not have survived without Benadryl. Patient second dose on 28Feb2021 and did not go to appointment due to being very sick. Caller stated she felt like she was going to die. Caller mentioned she took Benadryl and it pulled her out of it. The patient's doctor has advised her not to take the second Pfizer Vaccine, that she should take Johnson and Johnson vs Pfizer. She said her HCP told her she could do a different one for her second. Patient wanted to know what to Do she was very scared of the receiving the Second dose. Therapeutic measures were taken as a result of feeling that she was very ill, lethargic/ feeling lethargic and could not get out of bed, lightheaded, nauseated. The clinical outcome of the events was unknown.  No Follow-up attempts are possible. Information on lot/batch number cannot obtained.
Patient received first dose on 08/24/2020 and second dose on 5/24/2021.  He received an additional dose in error today 6/25/2021
Persistent chronic runny nose from morning after vaccine ongoing for over 2 months now.  The issue has been worsening over time, and chronic sneezing has been getting worse.  I have no history of allergies, but I wonder if the vaccine could trigger the onset of new allergies?  Also, 2 days after my vaccine I had my yearly bloodwork performed which showed low white blood cell and low platelet count.
Tingling lips; a throat reaction that feeling where you think you have to cough something out; This is a spontaneous report from a non-contactable consumer, the patient. A 67-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on an 16Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history was mentioned as in the last two years the patient had a reaction to almonds and mango both in a moment when she was stressed where she had a throat reaction which was worse and wound up taking Benadryl. An allergist told to the patient that she had a slight allergy to peanuts. The patient did not have any other serious history of food allergies. Concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, about 30 minutes after vaccination, the patient experienced tingling lips which lasted for several hours but there was no swelling and it didnt get worse. The patient also experienced throat reaction three hours after the vaccine, when patient was eating some peanuts. The patient had throat reaction with feeling where she thought she had to cough something out but it didnt get to the point where she needed to take Benadryl. The patient reported that she might be eating them too fast hence experienced throat reaction. No treatment was received for the reported events. The clinical outcome of tingling lips and throat reaction was unknown at the time of reporting.   No follow-up attempts are possible. No further information is expected.
pt recvd vax;1pm started crying, arching back;screaming type of cry;mom try to nurse pt but refused;PC to PMD;was advised to give apap q/ 4 hrs;4pm fell asleep for about 15 mins then crying cont;10pm asleep till next am;
Left deltoid area swollen on Sat. Sunday a.m. redness to elbow- also noted swelling extended to left elbow, red, and hot to touch-afebrile Monday decreased redness and swelling + ithching no pain, Ice pack and Benadryl.
At the 3rd day I started to felt some chest pain and some knees and ankle pain, which cames worse a long the days until I had to go to de ER for a bad chesting on March 25th
PATIENT EXPERIENCED A LOCALIZED RASH SHORTLY AFTER HAVING THE VACCINATION. I RECOMMENDED THAT THE PATIENT TAKE SOME BENADRYL TO HELP WITH THE RASH AND TO DISCUSS WITH HER PRIMARY CARE PHYSICIAN SINCE IT WAS A VACCINE AND MAY REQUIRE A STEROID DOSE PACK TO TREAT.
This spontaneous report has been received from a 74 year old female patient, who was reporting on herself. The patient's concurrent condition included cancer. The patient had concomitant medications but did not want to disclose the names of medication. No information regarding the patient's pertinent medical history and drug reactions or allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX 1 time injected vaccine (dose, route of administration, lot # and expiration date were not reported). On unknown dates, reported as for the last couple of years, the patient got pain in her back and sometimes in her rib cage. On unknown dates, she had two rashes in her back for a couple of months. The lab diagnostic studies included blood work on an unknown date (no results provided). The patient did not seek medical attention. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected because there was no consent to contact the patient's physician.
body aches, little nausea, and now c/o fever 100.6F. pt will be taking Tylenol for high fever- higher than 100.4° F.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 5-year-old male subject who was vaccinated with KINRIX, (GlaxoSmithKline).  There was no relevant medical history.  The subject had not experienced adverse events following previous vaccinations.  Concurrent vaccination included MMR II vaccine (non-gsk) (Merck; right arm) given on 20 July 2009; VARIVAX (non-gsk) (Merck; right arm) given on 20 July 2009.  Previous medications included Allergy medication (Allergy shot) given on 10 July 2009.  On 20 July 2009 the subject received a dose of KINRIX (.5 cc, unknown route, left arm) as the 5th dose in the DTAP series, and 4th in the Polio series.  The lot number was reported as ACZ0B115AA.  On 20 July 2009, less than one day after vaccination with KINRIX, the subject experienced swelling at injection site, injection site redness, and later on an injection site rash.  The healthcare professional reported that the subject experienced a 7 centimeter local reaction at the injection site in his left arm only.  The swelling and redness occurred the same day of vaccination but the rash developed later.  At the time of reporting, the rash had spread to the subject's elbow.  At the time of reporting the events were unresolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.
Information has been received from a registered nurse concerning a 5 year old female with no known drug allergies who on 03/11/1998 was vaccinated with varicella vaccine. In November 2001, the pt developed chicken pox. The exact number of lesions was not known when the pt was in the office for a routine check-up, the nurse noticed two crusted over lesions. The nurse reported that the pt's unvaccinated older sister developed shingles at the time. No additional info is expected.
tired; explosive diarrhea; slightly sore arm; maybe I was dehydrated; 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 DIARRHOEA (explosive diarrhea), PAIN IN EXTREMITY (slightly sore arm), DEHYDRATION (maybe I was dehydrated) and FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced DIARRHOEA (explosive diarrhea) and PAIN IN EXTREMITY (slightly sore arm). On 05-Mar-2021, the patient experienced FATIGUE (tired). In March 2021, the patient experienced DEHYDRATION (maybe I was dehydrated). At the time of the report, DIARRHOEA (explosive diarrhea) had resolved and PAIN IN EXTREMITY (slightly sore arm), DEHYDRATION (maybe I was dehydrated) and FATIGUE (tired) outcome was unknown.            This case was linked to MOD-2021-051406.
Rust color discoloration in both hands.; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event.  A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 28Feb2021, at 14:15 as single dose for Covid-19 immunization when the patient was 73-years-old.  Medical history included hearing problems from an unknown date. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. No allergies to medications, food, or other products were noted. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; lisinopril (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; ezetimibe (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced rust color discoloration in both hands on 13Mar2021, at 12:00. No treatment was received for the adverse event. The clinical outcome of rust color discoloration in both hands was not recovered.
01/15/22 presents to EC ED for "shortness of breath, cough". PMHx of "CHF"
This report was received for PEDIARIX. This report concerns a child patient who was vaccinated with a dose of HIB conjugate vaccine. Concomitant vaccination on the same day included diphtheria toxoid (+) hepatitis B virus vaccine (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid. Subsequently, the patient experienced a fever of 101.3 degrees F. Medical attention was not sought. The outcome of the event is unknown. This was originally reported by a physician. Additional information has been requested.
Rash where shot was given left thigh, 2.5 cm diameter with induration and erythema. Generalized maculopapular eruption on trunk. Associated with diarrhea and bleeding of blood in stool.
Several pts from this facility recv vax & devel inj site rxn with pain erythema & swelling.  They were evaluated in ER. Med Affairs Note: Reporter unable to specify # pts who exp this event.
Mother states: child began to develop a red raised rash on entire body within 1 hour of vaccinations. Red raised area to left leg where shot was given started like a bite and was dime sized the same day but progressed to silver dollar sized the next day. Fever was 99 on day of shots and went to 102 during the night. Mom had given Tylenol during the night. Saw MD on day one approximately 2 hours post shots and was sent home to use Tylenol.  Went to ER 24 hours post vaccinations and Mom was told it was an allergic reaction to pertussis.  She was to give Benadryl and Tylenol q 6 hours prn. On 7-7-08 child has so far recieved one dose of Benadryl. Child still has slight rash and Left leg looks a bit bruised.
Information has been received from a registered nurse concerning a patient who on 07-NOV-1996 was vaccinated with a dose of Varivax. Subsequently, 24-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
8AUG noticed bumps-welt like bumps, as time progressed swollen glands-became raised round, red in color, back of shoulders, rib cage number (5-15); 9AUG also broke out in red rash under the eyes, face & hairline;
Chills, low fever, headache, loss of appetite,  body aches, and lethargy for 2 days
Patient received live zoster SQ in post (L) upper arm. Noted swelling 1 day after vaccine. Increased today. Currently erythema & inflammation are 7.2 x 10.3 cm.