chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had a positive COVID test on 12/30/21 at the local County Health Department; 12/31/21 pt was found unresponsive by her husband at home in bed; EMS called; asystolic; ACLS started with CPR; ETT was placed and 3 rounds of epinephrine given during transport to hospital; pt remained in asystole and was pronounced dead at the hospital ED
Patient with rash, redness, swelling, and numb extremities to the arm she received the vaccination in the following day.  Patient also with painful axillary lymph node swelling noted the day after the vaccination.  Patient's first two Covid vaccines were Pfizer not Moderna, this was the patient's first Moderna vaccine.
a 15 months old patient received a dose of Pentacel which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255196, 2019SA254282 and 2019SA255195 (same reporter).  This case involves a 15 months old male patient who received a 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] which had a temperature excursion below zero/ lot UJ135AA, expiry date: 26-Feb-2021 via intramuscular route in the left thigh on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error due to incorrect product storage.  At the time of report no adverse event was 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.
Came to clinic on 08/26/2005 complained of possible reaction to yellow fever.  2 weeks later sitting at movie theater and heart started racing.  Complained of Fatigue and chest pain when fatigued, left of sternum.
Narrative: Patient denied any current signs/symtoms, said all side effects resolved. She never sought any emergency evaluation or treatment and denied need for evaluation/treatment today. Patient just decline to receive 2nd dose of Moderna Covid-19 vaccine.
I was riding an exercise bike for approximately fifteen minutes and noticed the heart rate monitor on the bike was above the 85 percent maximum heart rate indicator. I was not exercising very hard so I thought the monitor was incorrect. I was sweating much more than normal, so I got off the bike and switched to a treadmill the treadmill heart rate monitor confirmed the bike reading. I got off the treadmill and put on my mart watch which confirmed the heart rate as well I told my wife I have a heart problem and needed to go to the ER, we called 911 and an ambulance arrived in ten to fifteen minutes after calling and the EMT'S took my blood pressure which read 160/100 and my heart rate was APX 120 BPM. The EMT's put me in the ambulance and gave me four chewable aspirin and a nitroglycerin pill, throughout all of this no chest pain was present the only symptoms were the elevated heart rate and profuse sweating. By the time we arrive at the hospital which took approximately twenty minutes my resting heart rate was APX 80BPM and my normal is @ 70BPM. The hospital hooked me up to an EKG everything was normal I was kept overnight in the ER and scheduled an exercise stress test an Echocardiogram or the next morning. No structural abnormalities were found I was released the following day and was told to go to a facility and pick a Heart Monitor and wear for a week.
Unsure if she got the full dose or half dose/Unsure if she got 3rd dose or booster dose; Reaction/Severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION and INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 006B21A, and 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose). In December 2021, the patient experienced VACCINATION COMPLICATION. On 10-Dec-2021, INCORRECT DOSE ADMINISTERED (Unsure if she got the full dose or half dose) had resolved. At the time of the report, VACCINATION COMPLICATION outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
pt states that he thought the shot was a little high in the arm.  He experienced pain at the sight and it was painful to move the arm.  Some relief with ibuprofen.  He let it go awhile and made a complaint to the pharmacy on 11/5/19 in the afternoon.  He called back on 11/21/19 after seeing his md who told him he found shoulder damage from the results of an MRI
No adverse effects reported; Pharmacist reported that on 9/21/2020, the unspecified 11 year old patient was inadvertently administered a third dose of MMRII; This spontaneous report has been received from nurse practitioner and a pharmacist concerning a 11 years-old patient of unknown gender. The patient's historical drugs included the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), also reported as ¨ the second dose had been administered seven years ago.¨. The patient's concurrent conditions, medical history and concomitant therapies were not reported.          On 21-SEP-2020, the patient was inadvertently vaccinated with a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (dosage regimen, Lot # and expiration date were not reported). No adverse effects were reported.
Miscarriage - patient (myself) became pregnant in October 2021 and miscarried in December 2021. All vitals (hormone levels, bloodwork, etc.) came back normal.   1st Dose 7/7/21, 2nd Dose 8/6/21
Piercing pain. Soreness. Red swollen area 8" long x 3" wide, left arm, beyond elbow! 1/2" tall. Still hurts today off and on, all day itching. Hurt to lift left arm. "However, it is first time in 10 years I have not had the flu."
injection site had turned red with the other 2 doses.; low grade fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA and PYREXIA in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (She's in reminiscent for 10 years for a cancer.). Concomitant products included TIMOLOL for Glaucoma, ATORVASTATIN, ZOLPIDEM, and LATANOPROST for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA and PYREXIA. At the time of the report, VACCINATION SITE ERYTHEMA outcome was unknown and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade fever (High).         The concomitant drug Denlafaxine is used as substitute drug.  Treatment information was not provided.   This case was linked to MOD-2021-313629, MOD-2021-313718, MOD-2021-312651 (Patient Link).
First dosage: I started my period a week after the first vaccine,.  This is abnormal because my menstrual cycle ended on July 2, 2021, i have normal cycles, and I am no where near menopause.  I also had a sore left arm and had a slight dizzy spell.  Second dosage:  Headaches, chills, body aches, nauseated, sore arm, and dizziness,
Large area of redness and inflammation at the injection site. Red area was warm to the touch and the patient was also experiencing a headache.
Severe chills, shaking, fever (was 101.4 when measured later that morning.
mom states that 2-3 hrs after child received prevnar developed rash on face and neck.Child was not fussy itching, etc.  Mom said rash disappeared and hour later.Child has had no other problems.
On Day 1 of second dose, immediately developed Covid arm. On Day 2, developed a red rash (no papules or discomfort) on ankle tops & shins. Day 3 it spread out on leg tops. Day 4 the spots seemed to get larger and blend together, continued to move up legs into thighs. Day 5 more blending of spots on ankles, legs as there are now large red areas. Rash began to develop on arms. Day 6, rash spread behind legs and under the arms.  She only had mild itching at the injection site. Out of concern due to my mother's age I called her physician to report this on Day 3. Dr. advised her to take Zyrtec during day and Benadryl at night for itching as needed but did not see my mother. My mother has not taken these meds. She did not take any Zyrtec or Benadryl because she has no itching, just this awful looking rash that doesn't hurt or itch.  Occasionally she gets a prickle of an itch but not much.  She takes Tylenol for any aches of arthritis, too. I have pictures of each day of this if it is helpful to you. Today is Day 7 and her leg tops are beginning to look a little better but the backs of the legs and arms are now affected with the large almost melted rash into several big areas of red.  She also has minimal spots on her buttocks but nothing like legs and arms. Interesting it is only in her extremities (we are so glad!!) and we are hoping it will resolve completely.  She wanted you to know her reaction to help you.  Due to her age, I will be taking her calls for her.
Blood in stool, irritability, headache, muscle aches, chest pain, and fatigue
Dizziness, Severe Sweats, Muscle Spasms, body tremors, extreme Fatigue
received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023; injection site pain; headache; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose: 1st (Booster) Gray cap bivalent), administration date: 05Oct2022, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 04Jan2023, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 04Jan2023, outcome "unknown", described as "injection site pain"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 04Jan2023, outcome "unknown", described as "received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023".  Additional information: Nurse called about a patient who received the Pfizer COVID-19 Vaccine Gray Cap Bivalent twice within 3 months of each other on 05Oct2022 and 04Jan2023. The nurse was looking for further guidance. Called regarding the Pfizer Bivalent booster vaccine for 12+. On the 04Jan2023, had a vaccine clinic at the facility. One of the patients got two Pfizer bivalent boosters within 3 months. One booster vaccine was given 04Jan2023 and the previous booster was given on 05Oct2022. Talked to the patient and notified patient of this. Had talked to the provider as well. Patient reported no severe reactions, just injection site pain and a little headache in the past two days. Had reported the incidence already.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient felt very warm and tingle for about 10 minutes. This feel causes him to lose consciousness for approximately 10 seconds. He return to state of full consciousness. He stated he was okay, "just fell asleep for a second." Blood pressure reading was 115 / 55 about 3 minutes after event occurred. Monitored patient for full 30 minutes. He stated he felt fine after 30 minutes were up.
diagnosed with bell's palsy; A spontaneous report was received from a pharmacist concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Jan 2021, two days after receiving the vaccination the patient diagnosed with bell's palsy. The event was considered to be medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of reporting, the outcome of event was not reported.; Reporter'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. Further information has been requested
Left arm edema, erythema and heat covering entire distal to shoulder and immediately proximal to elbow. Pt c/o discomfort.
ER Director immunized on 9/27/2005. T/C 7/27/2006 "That each time he has a viral infection, at injection site gets a Quarter size hard lump a soreness on site." No redness. It has happened 4-5 times. Pt. also reported a Local reaction at vaccination site on 10/17/2005 Smallpox vaccine adverse Event Active Surveillance worksheet.
a bruise the size of a nickel appeared on sight on the morning of 4/9 (8 days after the first dose) and has grown to become the size of two quarters by 7PM. it is noticeably swelling and feels warm, and it hurts like a bruise when pressed.
On 9-23-13. Pt. received PNEUMOVAX approx. two weeks after Pt. noted to have become very forgetful. By Nov. 23 2013 Pt. noted to be very confused and disoriented.
hx of pt being irritable x 3 days p/DTP; Pt had shrill cry for first 24 hrs; t103-104;
He got his blood work with low platelets; first one was low and the second one was even lower; This is a spontaneous report received from a contactable consumer or other non-health professional (patient wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, patient got his blood work with low platelets. Reporter stated that she was concerned for patient as for the second time since he had the vaccine which was in January. Patient got his blood work with low platelets. The first one was low and the second one was even lower. Reporter was reading about some concerns and people quaking with same issues even people dying from this. So, reporter wanted to know how many people do you like have reporting this issue and what was the best way to approach this and what Pfizer can do because this was the first time that patient had this problem.Reporter stated that was her suspicion because after speaking to several physicians. They told that patient was not the only case. They have seen people with the side effect reaction. Reporter was wondering tomorrow her son 12 years old was going to get the second shot, so reporter was really concerned what was happening, she asked could you tell me what was happening with this situation specifically with the Pfizer vaccine from any people are you getting this issue. The patient underwent lab tests and procedures which included blood test: with low platelets. The report was not related to study or programme. The outcome of the event was unknown  Information about batch/Lot number has been requested.
Acne outbreak requiring medication following Comirnaty booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: ACNE (non-serious), outcome "unknown", described as "Acne outbreak requiring medication following Comirnaty booster".  Additional information: Patient reported acne outbreak requiring medication following Comirnaty booster. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extremely irregular menstrual period. I am on 11 days of bleeding right now. I am always on time every 29 days and since the vaccine, it has been every 21 days and lasting 10+ days, when it normally lasts 5.
Myalgia, Rash & NauseaVomiting Narrative: dose 1-at time of vaccine had nausea, headache, elevated BP after 45 minutes went home, had a loose stool, better after 2 days dose 2-day 2 nausea body ache; fatigue; chills; body rash;
I got four blotches on my right leg 2 by knee and 2 on chin.  Did a virtual visit with doctor.  They think it may be a bug bite of some kind but since it was within 24 hours of vaccine they wanted me to report it.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not provided. In or around December of 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided), at a medical center for routine health maintenance and for its intended purpose: the prevention of shingles. In or around January of 2016, the patient was diagnosed by a physician with shingles (herpes zoster); the rash lasted several weeks and caused severe pain. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), her symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had incurred and will continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome for herpes zoster was not recovered. The herpes zoster was considered a disabling event.
Red, swollen arm, fever, severe headache, nausea, muscle aches for one week.
Positive PCR test for Covid; Positive PCR test for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive PCR test for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive PCR test for COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200036625 same reporter/ drug/ event, different patient;
pt recv vax 19JAN98 & had mild URI, T to 100.2;20-21JAN fever 101 then awoke w/hive like rash;extremities face > trunk;allerg rxn;
Injury; Back pain; This spontaneous case was reported by an other health care professional and describes the occurrence of INJURY (Injury) and BACK PAIN (Back pain) in a 59-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJURY (Injury) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Back pain, at a dose of 300 mg and IBUPROFEN for Back pain, at an unspecified dose and frequency. At the time of the report, INJURY (Injury) and BACK PAIN (Back pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BACK PAIN (Back pain) to be not related. No further causality assessment was provided for INJURY (Injury).    No concomitant medications were provided.  The patient mentioned the back pain she had was because of an injury and unrelated to the vaccine.
Low grade fever; chills; body aches; This is a spontaneous report from a contactable consumer (patient's husband). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955, Expiration date: Unknown), via an unspecified route of administration in the left arm on 12Apr2021 10:15 as SINGLE DOSE for covid-19 immunisation. The patient's medical history included none. The patient had no allergies to medications, food, or other products. Concomitant medication included valaciclovir hydro-chloride (VALTREX) and doxycycline monohydrate (DOXYCYCLIN "GENERICON" 100). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP6955, Expiration date: Unknown), via an unspecified route of administration in the left arm on 22Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient experienced low grade fever, chills and body aches on 12Apr2021 10:30. The patient was not diagnosed to COVID-19 prior to vaccination and since vaccination. The patient did not receive treatment. The outcome of events were recovered.  No follow-up attempts are needed. No further information is expected.