chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "2 babies died during the trial period". The patient date of death was unknown. The reported cause of death was "2 babies died during the trial period". The reporter wanted to get information about the first 400 pages documents for the Pfizer vaccine. She mentioned that she is very concerned about the documents being released publicly. She also mentioned about the 3 month trial period where there is a recall on babies and she also mentioned that 2 babies died during the trial period and she's very concerned about it. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200354956 Same reporter/drug/event; different patient; Reported Cause(s) of Death: 2 babies died during the trial period.
Chills, cough, runny nose, severe body ache, cold sweat, head ache, sore throat the day after receiving vaccine.
Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 24-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2012, the patient was treated by a physician/MD for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a registered nurse concerning an 11 year old female, who on 21-AUG-2007 was vaccinated intramuscularly with a 0.5mL first dose of GARDASIL. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 29-AUG-2007 the patient developed a fever of 103F. The patient was lethargic, had diarrhea one time, and a severe headache. On 01-SEP-2007 the patient developed hives all over her body. The patient sought unspecified medical attention. On 02-SEP-2007 the patient's headache and fever resolved and the patient started to feel better. On 04-SEP-2007 the patient recovered and went to school. The nurse reported that she was unsure if the patient would be receiving the second dose of GARDASIL. No product quality complaint was involved. Additional information is not expected.
fatigue; pain; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 20-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero .5 ml. On an unknown date, unknown after receiving Bexsero, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported, however the patient's age group could be adult. The patient received Bexsero and experienced significant fatigue and pain which lasted for one or two days. The reporter agreed to be followed up.
Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 22 Sep 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 22 Sep 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 22 Sep 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Administered vaccine on 03 Nov 2021, from vial stored in refrigerator on 22 Sep 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No adverse events reported. No temperature excursion of the product was reported. Vial place in refrigerator was on 22 Sep 2021. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.No treatment information was reported.
I started off with a fever of 101.8, developed a rash on my torso, neck, face, ears, scalp. Experienced flu-like symptoms. I felt run down, tired. Lymph node swollen under the arm.
Pt vaccinated with MMR vaccine developed painful swelling in groin lymph nodes. Resolved in 14 days. No GYN, GU infection.
Severe bone and joint pain, headache, chills, fatigue throughout the night. Couldn?t sleep due to pain.  Slowly feeling better the next morning but had to take Tylenol to ease the joint pain.
This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 47 year old female. 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Company i unable to follow up for batch/Lot number of the case. No concomitant medications were reported.  On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566 and 20210441555. .
Patient's arm swelled significantly at injection site. Veins in hands also swelled. Injection site bulged. Patient said they felt OK just swelling was alarming.
Swollen soft aching lump under left arm; Swollen soft aching lump under left arm, located below armpit, which hurt the same as the site of the shot.; Swollen soft aching lump under left arm, located below armpit, which hurt the same as the site of the shot.; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female 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 18Jul2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Jun2021 at 09:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 19Jul2021, at 03:00, the patient experienced swollen soft aching lump under left arm, that was located below armpit, which hurt the same as the site of the shot(vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen soft aching lump under left arm (below armpit), which hurt the same as the site of the shot were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was reported.   No vial went any temperature excursions and it was reported that, there were no adverse reactions to the vaccine.  Company comment- This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the first dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow Up was received contains non significant information, added secondary reporter details.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine with lot number 049E21A. The event expired product administered occurred right after the first dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 32 days past its manufacturer date of expiry (manufacturer date of expiry: 11 October 2021, date of mRNA-1273 vaccine administration: 12 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
My lymph node were swollen in my arm pit, collar bone, and throat. I went to the doctor and did an exam and the doctor stated it would go away in a few months and to ice it.
Constant ongoing pain at injection site and shoulder (pain and swelling). Patient complain about shoulder pain while driving her car (when she steer her car's steering wheel).
I had 5 days of tachycardia that did not ease up at all, 3 days of severe migraines which also did not ease up at all. I also had a large red spot on my arm with a lump the size of my grapefruit. I stayed in bed, ate and drank and took care of myself. I might have taken ibuprofen. My symptoms were constant until they left.
Child received second dose of Pfizer Covid vaccine underage. Mother lied about child's age to get vaccine. Child was age 11,  not 12 as indicated on the vaccine administration record. Mother later admitted child was underage after inquiry during data entry.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 61-year-old male patient who received SHINGRIX. Previously administered products included Flu vaccine and Tdap vaccine. On 16th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, less than a day after receiving SHINGRIX, the patient experienced radiating pain and allergic reaction. On 16th February 2018, the patient experienced injection site swelling and pain in arm. On an unknown date, the outcome of the injection site swelling, pain in arm and radiating pain were recovering/resolving and the outcome of the allergic reaction was unknown. The reporter considered the injection site swelling to be probably related to SHINGRIX. It was unknown if the reporter considered the pain in arm, radiating pain and allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered nurse (RN). The age at vaccination was not reported but it could be 60 or 61 year old. The patient had no other reactions to other previous vaccines. The patient received SHINGRIX in left arm. The patient experienced softball size swelling on left arm at injection site and severe pain in their left shoulder radiating down the left arm, down through the abdomen, hip, and ankle all on left side. The patient was not hospitalized and symptoms were resolving at the time they were reported to their physician. The physician recommended patient not get 2nd dose of SHINGRIX due to the potential that these experiences were an allergic reaction to the vaccine. Nurse stated possibly related to either the SHINGRIX or the administration of the SHINGRIX, but no further details were available. The patient was instructed to report the experience also to pharmacy where they received the vaccination.
Injection Site Pain, Congestion, Fatigue, Swollen Lymph nodes, Nausea, & Headache
Pt in for 2nd dose HPV. Mother confirmed no previous reaction or allergies to vaccines.  After injection, pt. tolerated well and after a few minutes with exam room so hot and multiple people in room allowed pt. to get up and make way to waiting room.  After walking about 20 feet, pt. fell to floor.  Pt. did twitch and eyes rolled back to head about 20 seconds.  After helping pt. to chair he did regain consciousness and complained of headache and sore arm where the arm rubbed against wall at time of fall.  Pt. very pale and diaphoretic vitals obtained and BP/HR very low.  Pt. did state "All I have eaten is fruit snacks today." Mother admitted they had not eaten and she planned to go out to eat after the appointment.  Pt. remained in clinic x 1 hour and vitals stable at time of discharge.  Called Mother to check on pt. over next 2 days and no further symptoms noted.
No Adverse event; Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medications were reported. Patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657560:Same reporter US-MODERNATX, INC.-MOD-2022-657547:
felt tender; Swollen; Itchy; Red; I have COVID arm; Hot; bruising - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I have COVID arm), CONTUSION (bruising - left arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender) and VACCINATION SITE SWELLING (Swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced CONTUSION (bruising - left arm). On 19-Mar-2021, the patient experienced VACCINATION SITE REACTION (I have COVID arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red). On an unknown date, the patient experienced VACCINATION SITE PAIN (felt tender). On 19-Mar-2021, VACCINATION SITE REACTION (I have COVID arm) and CONTUSION (bruising - left arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot), VACCINATION SITE PAIN (felt tender), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Red) had resolved.            Concomitant medications were not provided. Treatment details : Amica Cream for bruising Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: ADR attached. Added patient demographics. Added new events and outcome.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid for Treatment of COVID-19 from 23Jul2022 to 03Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient was seated during vaccine administration- he looked and observed the injection process- as I withdrew the needle and covered the injection site with a gauze pad, the patient stated "I don't feel well" I observed his color change to pale, assisted him to supine position, +radial pulse throughout incident - did not respond to verbal stimulation for app 30 seconds, but then stated "ok" when I asked him if he was alright. Patient was monitored in the department for app 45 minutes, vital signs stable- alert oriented, ambulatory, drank water, juice, candy bar and buttered roll- as patient stated he did not have breakfast and he has fainted before when blood was taken.
Pt. rec'd HepA, varicella and meningococcal vaccines in few minutes mother brought pt back - Pt. was having SOB, swollen eyelids and lips, congestion: consulted DON and NP - Epi given 0.5 cc x 2 - 15 min apart per attending EMS order called. Pt transported to hospital.
cardiac arrthymia  Frequent Pvc's symptomatic initially usually NSR.  Started beta blockers and statins.  Ongoing issue requiring Cardiologist. Complete workup done.  Still ongoing.  Still with Pvc's . occasionally symptomatic.......
Injection site pain on 9/20/19 (2 days after injection) which caused a Rt sided headache which became intolerable and had to leave work to go home.  Headache was managed with ibuprofen.  Severe back pain on 9/23/19 (4-5 days post injection).  Intially dull and "achey," rated pain as 5-6/10, relieved with ibuprofen and heat pack as needed.  On 9/27/19, unable to sit for a morning meeting and had to stand due to back ache.  On 10/2/19, back pain increased to 7-8/10.  On 10/3/19 increased ibuprofen amount and used acetaminophen intermittently.  Called in sick from work on 10/4/19 due to back spasms.  Back pain tolerable 10/7/19 with medication and intermittent standing instead of sitting.  Leg pain started 9/20/19 (2 days post vaccination), which starts from lower back down to back of thighs.  Dull and achey pain, hurts when walking and when sitting for prolonged period of time.  Changes positions from sitting to standing and vice versa when pain is noticeable.  Still with back pain 10/7/19 that go down to back of thighs, but improving.  Taking ibuprofen and acetaminophen when need to.
Pt experienced throat swelling around 10 minutes after vaccination. She described the sensation as "tightness" and "something in the back of my throat." No visible angioedema at first evaluation. PO Claritin administered. Vitals remained stable throughout episode. Throat became visibly edematous around 20 minutes post vaccination. 0.5mg epinephrine was give at this time. (9:20am)