chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetnus, for immunization, reaction(s): "known allergies: Tetnus". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (08Sep2023) Negative, notes: Tested negative on Friday; (10Sep2023) Positive, notes: Subsequently tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was given Paxlovid from 31Aug2023 to 04Sep2023 for treatment of COVID-19. 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 tested positive for covid-19  2 months after receiving the second dose of Covid -19 vaccine
Patient informed medic while sitting in the observation area that she was experiencing chest pain, difficulty breathing and throat tightness.  Patient was taken to medic area vs=179/89, pulse 121, o@ sat 99%
Swelling at site of injection; very limited range of motion in injected arm; pain with movement; lethargy - all still present after 24 hours. Low-grade fever present on day of injection, resolved by day two.
Severe swelling from shoulder to elbow, redness, burning, and hot to the touch in the area of the injection. This increased in severity each day until I was prescribed an antibiotic to control. At this time there is significant dry skin with peeling in the area of the injection.
Right after the injection my heart started pounding. Hard pounding. I told the nurse. Did not stop the whole time I was there. I didn?t go to work after the shot because my heart wasn?t stopping. I went home and took my blood pressure and it was sky high. 198/103. I sometimes have anxiety but this was completely different. I went straight to bed to try and calm my body down. Stayed extremely high for a couple of hours. Dropped to 158/90 something. I have had up and down blood pressure ever since. I can feel it. Go take it and it?s higher than normal. Shooting up. I?m afraid to get the second shot.   Normally my blood pressure is around 127/81 controlled by small amount of benazepril. It now feels like it is out of control. Up and down all day. I have not gone to the doctor yet but am extremely worried about the next shot next week.
I have had a flu shot every year since I was a child. Upon getting this years shot I started to feel ill. I also had severe am pain. Two days later I am sick in bed with a cough, stuffy nose and no energy to lift myself up for more than a few minutes. I also have the worst arm pain of my life. It has not gotten better but worse. I cannot sleep or even wear a shirt with a sleeve because it hurts so much when it touches anything.  I have never had this happen before. I am in extreme pain.
on my hands look like blisters look like chicken pocks, they are quite painful and are opened up; on my hands look like blisters look like chicken pocks, they are quite painful and are opened up; cold sores all over my mouth and is painful to talk; cold sores all over my mouth and is painful to talk; This is a spontaneous report from a non-contactable consumer. A 48-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, she had symptoms after vaccine. She had the first dose of Pfizer vaccine last Thursday. She was having like on her hands look like blisters look like chicken pocks, they are quite painful and are opened up. They started on Saturday. She was having cold sores all over her mouth and was painful to talk. On an unspecified date in Apr2021, the patient experienced on my hands look like blisters look like chicken pocks, they are quite painful and are opened up and cold sores all over my mouth and is painful to talk. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
suspected vaccination failure; shingles breakouts, internal and external; feeling miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (the patient had terrible chickenpox as a young adult).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the patient had the vaccines and still get shingles internal and external. The patient stated that it was miserable and the patient wish on it no one. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Colon obstruction - GI did perform a flexible sigmoidoscopy which did not show any obvious stenosis but did show dilated colon.  Was felt to be likely functional problem.  Colon was decompressed. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
hardness at spot just below vaccination location; redness at spot just below vaccination location; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE INDURATION (hardness at spot just below vaccination location) and VACCINATION SITE ERYTHEMA (redness at spot just below vaccination location) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced VACCINATION SITE INDURATION (hardness at spot just below vaccination location) and VACCINATION SITE ERYTHEMA (redness at spot just below vaccination location). At the time of the report, VACCINATION SITE INDURATION (hardness at spot just below vaccination location) and VACCINATION SITE ERYTHEMA (redness at spot just below vaccination location) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided,  Action taken with mRNA-1273 in response to the event was Unknown
Patient seen at outside mass vaccination event on 7/2/2021 with guardian. Guardian completed form with patient's DOB as 09/09/2008, and confirmed patient was born in 2008. Pfizer vaccine dose 1 was administered. Guardian returned on 7/24/2021 for dose #2, and informed staff the DOB is 09/09/2009. Dose #2 not administered on this day. Patient to return when 12 years of age to receive dose #2.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Tachycardia-Mild, Additional Details: patient is able to swallow and drink water .Just complained of sore throat,. Called 911 , assessed patient \"Anxiety Reaction\".\r\n
APAP given around 3PM to sleep 5PM awoke @ 545 w/severe high pitched scream; To ER @ 6PM-no temp elevation; asleep 730PM awoke 5AM 11SEP91; back to normal behavior;
received pediatric dose of Engerix-B; received pediatric dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 60-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   On 9th May 2022, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The health care professional reported that adult patient received dose of pediatric Engerix B. No other details of patient could be provided. The reporter consented to follow up. Additional Supportive Information: An adult patient received dose of pediatric Engerix B at inappropriate age, which led to underdose and inappropriate age at vaccine administration. This case is linked with case US2022076268 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076268:same reporter
Patient received COVID 19  Booster shot on 02/10/2022 LOT#33036BD. Upon returning to the clinic on 02/12/2022.  The patient was lethargic and not feeling well.  Vitals were baseline for this patient. She complained of dizziness and fatigue post treatment.  She returned to the clinic 02/15/2022 and was back at baseline without complaint.
Covid 19; Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2021 as dose 3 (booster), single (Lot number: FJ1620), 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), COVID-19 (medically significant) all with onset 03Jun2022, outcome "recovering" and all described as "Covid 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive to Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient was treated with anti-viral drug of Paxlovid from 19May2022 to 24May2022 for COVID-19. The treatment medication included albuterol nebulizer treatments.  No follow-up attempts possible. No further information expected.
Muscle aches; Chills; Severe headache; Night sweats; Arm hurt more than normal; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the right arm right on 01Apr2021 at 09:00(at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. Concomitant medications included ethinylestradiol, norethisterone acetate (ESTROSTEP) from an unknown date for birth control.  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 vaccination. On 01Apr2021 at 20:30 the patient experienced chills, severe headache then night sweats and at night the arm hurt more than normal. On 02Apr2021 the patient experienced muscle aches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event chills, headache, night sweats, arm hurt more than normal and muscle aches was not recovered.   No follow-up attempts are needed. No further information is expected.
Got my period about 8 hours after injection - which was not in sync with my cycle.  The same thing happened after my 2nd shot - 8 hours after injection I started my period.  I have never started my period so close to the previous cycle.  Both periods were triggered by the vaccine.
from 3/21 until 3/28 i experienced on and off aches in my body, night sweats, dizziness, headaches and extreme fatigue. i also missed my period. i have seen a number of medical reports attribute missed periods to stress but i urge you to consider this a side effect of the vaccine. i get my period at the same time every month and it lasts 4 days every month because of my birth control. but i  didn?t have a period this month.
On Jan 31st noticed a rash forming on arm and warm to the touch. Saw a Dr. on Feb 3rd. Diagnosed with cellulitis.
Shortly after vaccination pt began to experience recurrent and worsening mouth ulceration that was diagnosed by biopsy in Oct 09 as Pemphigus vulgaris (PV). Symptoms: Oral lesions.
The patient was 12 years of age at the time of vaccination, and was inadvertently given the pediatric formulation for children 5-11 years of age for her first dose. The patients caregiver was contacted and informed of this error. Per CDC guidelines, the caregiver was advised that the child will not need to repeat the dose, and only will require the appropriate formulation for ages 12+ for her second dose to complete the series. No adverse reactions have been reported by the patients caregiver.
09/06/22 presents to ED for "rapid heart rate". PMHx of "chronic diarrhea, CKD"
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Pt was experiencing a severe anixety attack-Mild, Systemic: Hyperventilation-Mild, Additional Details: Pt was apprehesive about the shot upon arrival to pharmacy. Very nervous. Administer the vaccine and within a few minutes patient begin to complain of lightheadness/breathing issues. I called 911 upon patient request and emts arrived within a matter of minutes. They walked patient to ambulance to check her out. Patient returned to the pharmacy after about 30 minutes to check in with us. She was feeling a little bit better and EMTs believe she had severe anxiety attack.
No additional AEs,; expired lot of PROQUAD was administered on 3/2/2023; This spontaneous report was received from a medical assistant referring to a 5-year-old male infant. The patient's concurrent conditions, medical history, concomitant medications and drug reaction/allergies were not reported.  On 02-MAR-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5ml/once, lot #U022722, expiration date: 16-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse events (AEs) (no AE).
The patient had the first dose of GARDASIL 9 in October 2020. The patient would like to continue the series, but has not yet received the second dose.; No AE reported; This spontaneous report was received from a physician's assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On an unspecified date in October 2020, the patient was vaccinated with their first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported, that they would like to continue the vaccination series, but has not yet received the second dose (inappropriate schedule of vaccine administered). No adverse event (AE) was reported.
Following dose 2 of Lymerix, the pt developed peripheral neuropathy. As of 11/3/00, the outcome of the event in unknown.
Difficulty breathing, chest pain, dryness in lungs.  Continuing intermittently since vaccine up to and including date of report (5/29/21)
Quadracel given to 1 years old patient with no Adverse event; Initial information received on 02-Aug-2022 regarding an unsolicited valid non-serious case received from a physician.  This case is related to 2022SA318115(same patient).  This case involves a 1 years old female patient who was administered quadracel with no adverse event after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 27-Jul-2022, 1 years old patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml total (lot C59708A, expiry date: 02-Feb-2024) via unknown route in unknown administration site for immunization(product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
double vision; This case was reported by a consumer via call center representative and described the occurrence of double vision in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received the 2nd dose of Shingrix. On 14th November 2019, 14 days after receiving Shingrix, the patient experienced double vision. On an unknown date, the outcome of the double vision was recovering/resolving.   It was unknown if the reporter considered the double vision to be related to Shingrix.  Additional details were provided as follows: The patient had the second dose of Shingrix and experienced double vision and eyes are out of alignment. After closing the one eye she seen ok but both eyes open she seen double, one on top of each other.
eyes crossed/muscles in eyes are stiff; hideous eye pain; loss of balance; dizzy and keeps falling over side ways and is off balance because she is cross eyed; patient is sick even now; Initial information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 84 years old female patient who developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].    The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication included vitamins. Patient said she only takes vitamins and no other medications and is very healthy otherwise.     On 25-Sep-2020, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number and expiration date unknown] via unknown route in the left arm for prophylactic vaccination.  On 19-OCT-2020 (latency 24 days) after administration of suspect the patient had developed eyes crossed/muscles in eyes are stiff (Strabismus), hideous eye pain (Eye pain), loss of balance (Balance disorder), dizzy and keeps falling over side ways and is off balance because she is cross eyed (Dizziness )and patient is sick even now (Malaise).  Patient said the paper that the pharmacy gave her says that Fluzone HD can cause motor problems and trouble controlling body movements and vision changes. Patient said the muscles in her eyes are stiff. Caller was very agitated and she said she is exasperated by all this and did not wish to provide more information.    Patient said she will never take this vaccine again.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.   At the time of reporting, outcome was not recovered for all the events.  There will be no information available on the batch number for this case.
Swollen tongue; burning sensation of tongue; tingling on the entire tongue; small bumps on the side of tongue; slight headach; mild body weakness; Sore throat; mild muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 36-Year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER 8727) via an unspecified route of administration on 19Mar2021 at 14:30 on the left arm as a single dose for COVID-19 immunisation. No known medical history No concomitant medication was not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021, the patient experienced swollen, burning sensation and tingling on the entire tongue; small bumps on the side of tongue, progressively worst on the very back; mild, sore throat; very slight headache and mild body weakness. No treatment was received for the adverse events. 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 of the events swollen, burning sensation and tingling on the entire tongue; small bumps on the side of tongue, progressively worst on the very back; mild, sore throat; very slight headache; mild body weakness with mild muscle aches was not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.
fever later that same day swollen lymph nodes in armpit (felt like the size of a tennis ball) next day joint pain in knee, shoulders, back, hips (especially intense pain in left knee) next day swollen legs especially noticeable in feet and hands at the same time the joint issues started numbing/nerve issues in hands and feet (on and off)  headache lower back of skull about a week after, went away  I took acetaminophen and ibuprofen as recommended I also took a muscle relaxant as prescribed for muscle ache  I continued to have pain which was intense in the joints and was further prescribed gabapentin (I was not taking the muscle relaxant at the same time as that) My joints were making popping sounds and at one point my knee snapped and caused me to fall I went back to the doctors office again and they upped the gabapentin dosage.