chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from consumer on 05 Jan 2018. This case involves 16 years old female patient who was vaccinated with dose of TYPHIM VI and YF-VAX (batch number, expiry date, route and site of administration were not reported) on an unspecified date in February 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date in September or October 2017, post vaccination she experienced headaches and was diagnosed with daily persistent headache syndrome. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
positive test; positive test; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "recovering", COVID-19 (medically significant) with onset 03May2022, outcome "not recovered" and all described as "positive test". Symptoms are much worse with the rebound infection. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: Tested negative 4 days after first positive test and 4 days into paxlovid treatment; (29Apr2022) Negative, notes: Tested negative 4 days after first positive test and 4 days into paxlovid treatment;(03May2022) Negative, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests; (03May2022) Positive, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests; (03May2022) Positive, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out.
Information has been received from a registered nurse, concerning a 20 year old female patient, with oligomenorrhoea, who on 05-JUN-2007, at 11:30am, was vaccinated with the third dose, 0.5ml, IM, of Gardasil (Lot #657622/0388U). There was no concomitant medication. On 05-JUN-2007, at 8:00pm, the patient developed a fever of 101F, with chills and muscular weakness. On 06-JUN-2007, the patient visited her physician, and stated the physician "thinks that it's a natural virus infection." At the time of this report, the patient had not recovered. Additional information has been requested.
PT arrived for booster dose (Pfizer, LOT 30155BA).  @ 1917, After 7 minutes in Observation, PT Reported rash on left arm at injection site.  PT escorted to Special Observation area by Safety Officer.  PT reported similar anaphylactic reaction to primary dose (J&J, LOT 202A21A).  In Special Obs.  Mild rash appeared on collar bone, upper back, Itch and pulsing feeling in vax admin site, tickle in throat, flushing of cheeks.  NO difficulty breathing, no airway compromise.  PT expressed desire to treat with Benadryl when returning home.  @ 1925 BP  128/98, PR 107.  PT Observed for 35 minutes symptoms improved.  Mild rash on upper arm @ vax admin site and flushing cheeks persisted.  Resolution of other symptoms on site.  @ 1943 BP 124/89, PR 103.  PT expressed desire to leave and treat at home.  PT left Vaccination site AOx4, Stable & Ambulatory @ 1952.
feeling light headed and dizzy; didn't think I'd be able to even get up; This is a spontaneous report from a contactable consumer (Patient).   A 65-year-old male patient started to receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date were not reported), via an unspecified route, on and unspecified date, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that she received the first dose of the Pfizer vaccine on Friday and everything was fine on that day. The next morning while laying down working on some equipment, he started feeling lightheaded and dizzy. At times he was dizzy and did not think he would be able to even get up. She heard from some nurses that this could be a side effect of the vaccine, feeling lightheaded, dizzy or disoriented. omething like feeling seasick. He was feeling a little better, when he stands up it got a bit worse. The outcome of all the events were unknown.   Follow-up (30Mar2021): No new information received from the contactable consumer (Patient).  Follow-up attempts are completed. Information on the lot/batch number has been requested.
While trying to go to sleep my arm was very painful to lie on and is very hot to the touch.
pt recv vax & pt believed to have been exposed to rubella p/vax;pt exp rash, joint pain, runny nose, minor sx indicative of rubeola;lab eval came back negative for rubeola in IgG & IgM but positive to rubella;
After receiving vaccine at 4 PM, arrived home at 6:00 PM and developed nausea and mild vertigo. Ate a small dinner and went to bed. Slept well. In the morning around 8:30 AM had 2 episodes of vomiting and 1 bout of loose stools. Low grade fever 100. I spoke with patient at 11:00 AM and she is improving. I recommended to increase fluids and seek medical treatment if symptoms do not resolve over the course of today or worsen.
COVID: Symptom onset 7/31.  Diagnosed 8/2. Has been having progressive Fever, chills, dry cough, and fatigue/weakness. Fully vaccinated for COVID. Denies any SOB or CP. No abdominal pain or nausea.  Found to be hypoxic in the ED requiring 2-4L. Also found to be in AFib with RVR unto the 150s. 8/9: Currently on 15 L/m Non-rebreather
Arm sore at site of injection; Cold sore on mouth; Feeling lethargic; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 31-JAN-2023, the patient received the 2nd dose of Shingrix. On 03-FEB-2023, 3 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Arm sore at site of injection), cold sores (Verbatim: Cold sore on mouth) and lethargy (Verbatim: Feeling lethargic). On 10-FEB-2023, the outcome of the injection site pain, cold sores and lethargy were recovered/resolved (duration 7 days).   It was unknown if the reporter considered the injection site pain, cold sores and lethargy to be related to Shingrix.     It was unknown if the company considered the injection site pain, cold sores and lethargy to be related to Shingrix.   Additional Information: GSK Receipt date: 14-MAR-2023 The reporter was the patient. The patient stated that she had the second Shingrix (singles vaccine) and had a cold sore develop on her mouth that lasted about a week.. The patient also stated that she felt lethargic for a couple of days after the shot, also stated that her arm was sore at site of injection.  No other information provided
Hair loss - Telogen Effluvium; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (age at vaccination was 53-year-old) as dose number unknown, single for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history was reported as none. The concomitant medications were not reported. The patient was not allergic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. On 26Jul2021, the patient experienced hair loss-telogen effluvium. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) was negative on an unspecified date through nasal swab. Therapeutic measures were taken as a result of event. The treatment medication included over the conger medication for the event. No seriousness was reported for event. Outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Had Dtap, Hib, IPV, PCV, HBV on 7/13/06 (all #2 shots), on 8/25/06 developed croup and decreased movement of extremities. Final DX of Transverse myelitis. DC DX: Cervical and upper thoracic spinal cord lesion consistent with inflammation likely from a post infecitous etiology. MRI of cervical and thoracic spine demonstrate extensive T2 abnormal signal in the cervical and upper thoracic cord, most suggestive for a process such as transverse myelitis. Per 60 day follow up: He continues to have residual neurological symptoms of transverse myelitis, with muscle weakness & hypertonia. University infectious disease of neurology are following this child. 1/12/2010 Patient continues iwth neurological delicate consistent with Transvers myelitis with quadriporesis.
Patient received post-exposure rabies treatment -- 3 shots; 1 vaccine, 2 immunoglobulin.  Doctor informed us that she would need "adult dosage" of immunoglobulin.  12 hours later, patient was running high fever -- over 103 degrees and was restless.  1 & 1/2 tsp. of Children's Tylenol was administered.  Within two hours, the fever broke, and the patient rested comfortably.  Nighttime pediatrician oncall did not think it was related to rabies treatment.  There were no other signs of illness in the next week.  Doctor felt it may have been due to the high dosage of immunoglobulin or the combination of that with the vaccine.
REDNESS AND SWELLING AT INJECTION SITE AND FEVER OF 101 DEGREES. REDNESS OF ALL OF UPPER ARM
No side effects when going to bed except sore shoulder. Woke up at 7 and felt "okay". Sat at table, one sip of coffee and my vision began to turn very white. My partner said I briefly passed out and my body was shaking. I was unaware of this. I broke out in a cold sweat. My partner said my face turned bright red. I felt a little nauseous but didn't vomit. I sat for 10 - 15 minutes with my eyes closed. I then felt well enough to get back to the bedroom with assistance. I slept for a couple of hours. I was then able to get up with no vision issues although was not back to "normal".  Just felt a little off. As they day progressed I felt better. Woke up this morning feeling fine.
who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial; who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial; This is a spontaneous report from a contactable consumer or other non hcp. A child patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the consumer had searched the website and cannot find anywhere that states who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial. The patient died on an unspecified date. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: who is responsible and/or liable when a child is injured or dies during a COVID vaccine trial
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Medium
Information has been received from a nurse concerning an 8 month old female who on 11-DEC-2007 was vaccinated with her third dose of COMVAX (Lot #0377U/Batch #657380) intramuscularly in the left thigh. Her second dose was received on 02-JUL-2007 intramuscularly in the left thigh (same lot and batch number). Concomitant therapy included influenza virus vaccine (unspecified), PREVNAR and TYLENOL. On 11-Dec-2007 the patient developed redness and swelling at the injection site. Patient's illnesses at the time of vaccination were an upper respiratory infection with nasal congestion and cough. Further information is not expected.
Present at clinic with mother to offer emotional support. Justice suffers from anxiety related to receiving medical care. Today was his second attempt at getting the vaccine. Reported to clinic staff after the fact: Had blurry vision and dizziness prior to entering clinic. Had sat in warm car for several minutes trying to work up nerve to enter building. Dizziness increased at time of vaccination, client was moved to floor, legs elevated until dizziness passed. Slowly transition to sitting and then stannding, monitoring vitals at transnitions. Patient walked out of clinic one hour after vaccination. Patient remained conscious. Consumed 3 bottles of water, two bananas, two juiceboxes during recovery period.
Subject complained of nausea and sore throat with flush feeling in face. Subject was given Sprite and Tylenol (2).
kidneys were at failure points; weakness like his running out of gas/lack of stamina; local arm tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of RENAL FAILURE (kidneys were at failure points) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0H0B21A and 0021321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site). On 17-Apr-2021, the patient experienced RENAL FAILURE (kidneys were at failure points) (seriousness criterion medically significant). At the time of the report, RENAL FAILURE (kidneys were at failure points), ASTHENIA (weakness like his running out of gas/lack of stamina) and VACCINATION SITE PAIN (local arm tenderness at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received his first dose of the Moderna vaccine on 15-Mar-2021 and had "zero side effects." The patient reported that his kidney function was normal before the second shot, but a week after the second shot, his kidneys were at failure points. No treatments were taken.  Company comment: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time.  Further information has been requested.
Information has been received from a physician and concerning a 15 year old caucasian female student, with a history of vagal reactions or "fainting with any phlebotomy," who on 04-MAY-2007 was vaccinated IM, with the first dose of Gardasil (Lot # not specified).  Following the vaccination, the patient fainted, described by the HCP as a "significant vagal reaction". Treatment involved the administration of an ammonia inhalant. She recovered after an unknown duration of time (date not provided).  On 06-JUL-2007, the patient received her second dose of Gardasil (Lot # not specified), and "everything was fine." With no problem noted. Additional information is not expected.
Shingles started to present on my face approximately 6/12/21. This lasted for about a week and a half after being prescribed Acyclovir.  This may not be related to the vaccine given the time since the injection; however, v-safe recommended I submit a report just in case.
Raised large patch around vaccination site arising about a week after the shot, some pain and redness, nausea
approx 36hr p/vax 3x3cm area @ inj site of erythema, warmth & edema w/itch;afeb;pt also c/o bug bites;
Two separate episodes of seizures lasting approx. 20-30 seconds with 1.5 hrs in between. Eyes opening wide then rolling back, full body posturing without shaking. She remained sleepy later. This happened 3 times. EEg was done and was put on phenobarbital + Lamictal, ativan. An annual follow up report received 6/26/2003 adds: Do not think seizure is from the vaccine.  Pt continued having seizure disorder, but I do not feel it is from Hep A vaccine since the other sibling also began to have seizure not related to vaccination. Etiology still unknown.
Patient received Moderna Vaccine in January of 2021. He thought that if he did not get the second shot within 30 days that it was invalid. Patient came in and got the Pfizer vaccine today 10/16/2021. No current symptoms or adverse actions within first 15 minutes of vaccination.
It was reported that a 39 year old female pt received a TD Adult vaccine, intradermal on 01/26/2001 at 12:30pm. Reportedly on 01/27/2001 at 2pm, the pt developed a 5cm redness with 1-2 cm induration and itching. The pt reportedly recovered from this event.
Administered a 0.5 mL dose when a 0.25 mL dose was indicated. No side effects since immunization.
Blood pressure is now 169/92 - typically 116/65.  chest pain/back pain between shoulder blades/cough
first dose was administred on 28Dec2020 and second dose on 21Jan2021; Sore arm at injection site; body aches during the second shot for a full 24 hours; This is a spontaneous report from a contactable pharmacist (the patient).  A non-pregnant 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the left arm on 21Jan2021 as a single dose for COVID-19 immunization. Medical history included asthma. 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. Concomitant medications taken within two weeks of vaccination included spironolactone, ethinylestradiol, levonorgestrel (AVIANE), cholecalciferol. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine include the first dose of BNT162B2, lot #EK9231, intramuscular in the left arm on 28Dec2020 at the age of 26-year-old for COVID-19 immunization. On 22Jan2021, the patient experienced sore arm at injection site, (but not as severe in comparison to the flu shot), and body aches during the second shot for a full 24 hours. The events were reported as non-serious. Treatment for the events included acetaminophen 500 mg - 2 tablets by mouth twice daily. The clinical outcome of the events sore arm at injection site, and body aches during the second shot for a full 24 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
pt recv vax 13JUN95 & 21OCT96 pt exp full blown chickenpox w/66 spots;23OCT96 pt presented to MD & was treated w/med;
excruciating and debilitating low back pain; chills for about 10 hrs; body aches for about 10 hrs; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs). At the time of the report, BACK PAIN (excruciating and debilitating low back pain), CHILLS (chills for about 10 hrs) and MYALGIA (body aches for about 10 hrs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
I couldn't turn myself over in bed; Legs wouldn't work; Couldn't stand up; My neck hurt so bad I had to lay flat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   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. On an unknown date, the patient experienced HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed). At the time of the report, HYPOKINESIA (Legs wouldn't work), DYSKINESIA (Couldn't stand up), NECK PAIN (My neck hurt so bad I had to lay flat) and SLEEP PARALYSIS (I couldn't turn myself over in bed) had resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-057062 (Patient Link).
Information has been received from a licensed practical nurse concerning a 61 year old patient who on 04/21/2003 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644106/0819M).  On 04/22/2003, "about 24 hours later", the patient developed cellulitis.  Unspecified medical attention was sought.  It was noted that the patient was recovering.  There was no product quality complaint involved.  Additional information has been requested.