chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 34-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration on 08Jun2021 as 1st dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date Jun 2021, the patient stated that she feels numb, like she is not hungry, cannot sleep, didn't sleep last night, feels like she has insomnia severely. Caller stated, "I started experiencing, I was fine then sleep went away. I noticed more energy yesterday, I thought, I have a lot of energy, but by 11PM wasn't tired at all and just got worse over night. It's constant, I don't feel manic, but I do feel awake, feel awake with more energy than usual, my head feels pressured, my whole body feels like I'm being squeezed. It's like an emotional numbness, insomnia, not feeling hungry or anything". The patient had nausea as well. Side effects that patient experienced throughout the rest of her body (systemic side effects) included fever and chills, were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. The outcome of all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
pt had gen reddened pox-type vesicles;no pustules formed but vesicles had a small scab in center of vesicle;no fever reported;no pruritus x/for those close to hair line;probably 20-25 vesicles over child's body;
Breakthrough case:  I thought I was feeling severe allergies, but when it wasn't getting better, I took a COVID test and it came back positive. Since I work with the public, I wanted to sure this was accurate, so I went to the ER to confirm this, and I tested positive as well.
SEIZURE-LIKE ACTIVITY; PAIN IN ARM; This spontaneous report received from a health care professional concerned multiple patients of unspecified age and sex. 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: 201A21A, expiry: unknown) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patients experienced seizure-like activity and pain in arm. It was reported that, while the patients sat in the observation area, seizure-like activity was noted for 5 seconds. The patients complained of dizziness (subsumed under seizure-like activity), and pain in arm. The patients were observed for 2 hours and discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure-like activity and pain in arm was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209 and 20210417456.; Reporter's Comments: The case is a multiple patient case.; Sender's Comments: V0: 20210418457-covid-19 vaccine ad26.cov2.s-seizure-like activity. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Of note - the patient also developed a viral-like illness on 12/24 - approx. 2 weeks after the vaccination, and approximately 1 week before the adverse event. The patient initially developed paresthesias and weakness in her lower extremities. This progressed to a diagnosis of Guillain-Barre Syndrome. She was under my care at the hospital starting 1/4.
Patient was administered AFLURIA QUADRIVALENT IM in the left arm per standard operating procedures on 09/25/2018. On 09/28/2018 the patient called the pharmacy at 05:20 PM and reported that on the morning of 09/26/2018 two "floaters" appeared in her right eye's field of vision. The "floaters" were described as "shadows that moved with the eye" and there were two of them, "a big one and a little one". The patient reported that they have not gone away as of 09/28/2018, and she was instructed to contact her doctor as soon as she could.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2021, single dose, for COVID-19 immunisation. Medical history included patient had difficulty breathing prior to the vaccine (unspecified if ongoing). The patient's concomitant medications not reported. Onset 2021,  patient had fatigue (tiredness), dyspnea (SOB), with outcome of unknown; dyspnea (trouble breathing), with outcome of not recovered; and nausea (queasy stomach), with outcome of unknown. Additional information: Patient received the Pfizer COVID-19 vaccine Jan 2021 and looking for a copy of the vaccination card (she wanted a replacement). Patient had difficulty breathing prior to the vaccine. She had some side effects from the vaccine she received in January. Stated she had been queasy on the stomach and not sure if that was associated with the vaccine. She also had difficulty breathing after walking and becomes winded. For the last few months, she had trouble breathing. This occurs especially when she was exerting herself, such as raking leaves, walking or walking any distance like in the mall. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM.  After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo;  additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
First day: sore arm, Second day: 4 inches of swelling and firm skin, soreness from shoulder to fingers, fever, flu like symptoms, fever, chills, lack of appetite, nausea, dizziness, headache, confusion. Third day: felt normal other than arm soreness
Bronchitis; Cough; This case was reported by a physician via call center representative and described the occurrence of bronchitis in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 4 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced bronchitis and cough. On an unknown date, the outcome of the bronchitis and cough were not recovered/not resolved.   It was unknown if the reporter considered the bronchitis and cough to be related to Shingrix.  Additional details were reported as follows: In mid October 2019, the patient received 1st dose of Shingrix. The patient received Shingrix approximately one week ago prior to reporting and around four days after receiving the vaccine, he developed bronchitis and describes that she has been coughing. Reporter did not consent to follow-up. This case has been linked with another case US2020000943, reported by same reporter.
Covid rebound.  Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.; Covid rebound.  Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8730), in left arm, on 05Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 01Apr2022 at 16:30 as dose 4 (booster), single (Lot number: FJ9943) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "blood clot in leg", start date: 2017 (unspecified if ongoing), notes: blood clot in leg in 2017. The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "Covid rebound. Covid symptoms 5/21/22, positive PCR test taken afternoon of 5/22. First Paxlovid dose evening of 5/23, complete course morning of 5/28. Two negative antigen tests on 5/29/22.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Negative; (29May2022) Negative; (02Jun2022) Positive, notes: in the afternoon; (22May2022) Positive, notes: positive PCR test taken afternoon of 22May. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: No Other medication in 2 weeks.Covid rebound. Covid symptoms 21May2022, positive PCR test taken afternoon of 22May. First Paxlovid dose evening of 23May2022, complete course morning of 28May2022. Two negative antigen tests on 29May2022. Headache, sore throat, upset stomach morning of 02Jun2022 and Positive antigen test in the afternoon of 02Jun2022.  No follow-up attempts are possible. No further information is expected.
Admitted to hospital with rhabdomyolysis and renal failure.  Also reported severe headache and abd pain prompting CT scans.
ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Abdominal cramping with nausea at 4:30 PM with diarrhea soon after, lower back tightness and headache later in the evening. Chills/sweats during the night. Patient came back to clinic in the morning for treatment and to report symptoms. PT treated with Promethazine and Mobic and given 24hrs bed rest.
Varicella vaccine breakthrough.  Seen 6-24-08 with over 100 lesions, no fever, diagnosed with varicella.
While administering dose with vanishing point syringe the syringe malfunctioned and patient did not receive full dose. Estimate that patient recieved less than half of dose. Contacted Manufacturer to advise. Per discussion and recommendations from the agency patient is eligible to be readministered the first full dose ASAP in opposite arm.
Narrative:  Patient contacted call center day prior to second dose of his vaccine. On phone call, patient described ADRs experienced after first dose - "sore throat, sore arm, heavy fatique and mind foggy" Endorsed that symptoms lasted ~ 1 week. Patient is self-employed, and refused second dose of vaccine because they stated they could not afford to stop work for 1 week as they did after their first dose of vaccine.
Coughing at 4:45 PM, Hoarseness worsening for next hour. Chest tightness and shortness of breath starting at 5:00 PM.  No appetite for dinner. Chills & fatigue starting at ~7:30 PM.  Red eyes noticed at 8:00 PM.  Severe weakness, chills, and inability to stand and function at ~8:30.  Vomiting at 8:30.  Felt somewhat better after vomiting 3 times.  Fever of 102.2 and severe weakness/chills at 10 pm.  Slept through night, severe headache, fatigue, and weakness in the morning but fever down.  No medication taken. Was at store during vomiting and weakness.  Ambulance was going to be called b/c I couldn't stand up to check out or even use phone to call family, but was able to drive home after vomiting. Still feeling weak with headache at 11:40 on 9/14/2011 - stayed home from work.
HYPOTENSION 11/27/2021 AORTIC ANEURYSM, UNSPECIFIED SITE HYPOTENSION 11/27/2021 AORTIC ANEURYSM, UNSPECIFIED SITE HYPOTENSION 11/27/2021 PROSTATE CANCER HYPOTENSION 11/27/2021 PARKINSONS DISEASE
DIARRHEA; BODY ACHES; LEG PAIN; HEADACHE; INJECTION SITE PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 58 year old. 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced back pain. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, and headache on 11-APR-2021, was recovering from injection site pain, and leg pain, and had not recovered from diarrhea, and body aches. This report was non-serious.
Shoulder tensed and locked up after getting the second dose; nerve pain down the arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm). The patient was treated with PARACETAMOL (TYLENOL) for Nerve pain, at a dose of 1 dosage form. At the time of the report, PERIARTHRITIS (Shoulder tensed and locked up after getting the second dose) and NEURALGIA (nerve pain down the arm) outcome was unknown.            No concomitant medications was reported    This case was linked to MOD-2021-225968 (Patient Link).; Sender'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.
Hives after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after vaccination) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives after vaccination). At the time of the report, URTICARIA (Hives after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  The patient had called to report her adverse events following vaccination mentions she knows a lot of people who are experiencing hives after vaccination.   This case was linked to MOD-2022-438713 (Patient Link).
Information has been received from a physician concerning a female who in mid February 2008 was vaccinated with GARDASIL (lot # not reported) and MENACTRA (lot # not reported).  It was reported that "the patient fainted shortly after the vaccine was administered."  The patient fully recovered while still in the office.  No product quality complaint was involved.  Additional information has been requested.
On evening of 12/30/2020 left arm started itching ,noted a rash. The morning of 12/31/2020  left arm was red and warm to touch,  moderate amount of itching . Went to Manager and she sent me to employee health. There they documented reddened area was about 3 by 4 inches and warm to touch.  The Doctor  was there also observed my arm, stating to do cold compresses and take Benadryl for the itching and symptoms. My arm stayed warm to touch and gradually the reddened area disappeared in about 5 to six days.
Fever 102F and moderate swelling, redness and warmth 6x6cm and severe pain right (vaccine site) deltoid.
ringing ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). 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 2, 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 (Dose 1, Single; manufacturer unknown), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing ears". The event "ringing ears" required physician office visit.  Additional information: after getting second dose of Pfizer vaccine patient got ringing ears. Patient asked how patient can get rid of it as it's bothering patient and altering patient's daily life. The patient had doctor, but they couldn't do anything about it. Reportedly, serious: no.  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.
I95.9 HYPOTENSION 6/7/2021 RIGHT DISTAL FEMUR UNSPECIFIED TYPE FX, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/20/2021 RIGHT DISTAL FEMUR UNSPECIFIED TYPE FX, INIT
Mom reported noticed fine rash at diaper line on 3/16/20, spread onto chest, arms, neck-itchy papular rash. Returned to clinic 3/18/10 for MD visit. No fever. MD, tyi 2.5 w/c qd, BENADRYL 12.5mg/5ml PRN. Rash upper body different? measles vaccine rxn.
6 days post vax pt experienced a fever of 103-104F which ended in 2 days. The next day pt experienced a few bumps. Within two days pt was covered head to toe with vesicular lesions all over the body. Three days later there were only a few pinhead size scabs remaining. Pt recovered.
Information has been received from a pharmacist who stated that a physician contacted her and reported that a female patient, who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not provided), had a positive HIV test result (date not provided). At the time of the report the patient's outcome was unknown. Additional information has been requested.
Received GARDASIL shot on 8/18/09.  Developed hives on 08/20/09 w/c lasted 2 days and an ED visit on 8/21/09.
Developed MRSA in right knee. No open wounds. Knee swelled had to have 3 operations.
pt recv 1st & 2nd doses varivax 4/3& 5/20/96 then 4/22/98 pt devel chickenpox
Only received one dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Only received one dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only received one dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only received one dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
SHE STATES SHE NOTICED THE RED SPOT ON HER INJECTION SITE A WEEK LATER. She has not treated it with anything, however she was concerned enough to call. She states she does not need a follow up call, she just wanted to report it. RN advised her to treat with cortisone and watch it. Caller was agreeable.
Case complains of chills, sweats, nausea, severe body aches, stiff neck, headache, restlessness, slight congestion, sinus pain, fatigue 10 hours after receiving immunization. Client slept for several hours and is somewhat better.  Client states that she still feel awful and body aches remain.
Dizziness; Heart palpitations; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 24-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations). At the time of the report, DIZZINESS (Dizziness) and PALPITATIONS (Heart palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment details not provided.
Within a half hour of receiving vaccine, I started feeling prickly from my torso down.  When I got home I realized that I had felt this before and immediately removed my scrubs.  I had raised red areas on my bilateral thighs and torso.  I took Benadryl po.
9 days p/vax pt ran fever 104 & rash all over face/ears/torso/limbs & swollen feet & staring spells; 1 wk later unable to walk from swollen joints/swollen glands & fever 104 & another rash on torso
This patient was seen today in office for vaccines pt got tdap, hpv, meningitis vaccine. After the vaccines were given the patient began to feel nausea, dizzy, weak & and "hot on her back". We went to get staff. We noticed that she was pale we took he bp and bs. Her blood sugar was 89 NF and her bp 77/39. Staff thinks it could possibly be vasovagal. Could you run this by Dr  if she would need any further testing before she continues any further vaccines series.
pt got shot 4PM pt was fine till approx 7PM;mom stated pt then started to c/o soreness @ the inj site;mom gave the pt APAP;the next AM pt refused to walk on the rt leg;It was red, hot, swollen from the site the knee;saw MD just local rxn