chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client had syncopal episode about 2 minutes after receiving ID vaccination. Client fainted and looked paled after vaccine administration. Vital signs were initiated, ice packs were applied, client was placed in supine position with legs elevated. Client verbalized feeling better after a few minutes , however felt nausea and a bit dizzy. Was observed for additional 30 minutes until client attested to feeling better. Client left clinic feeling well.
pt recv vax 17MAY96 & 6hr p/vax pt exp a sl episode of vomiting, fever & irritability;presented to ER on 19MAY96 CXR negative & blood cult showed no growth p/7 days;a strep screen negative;lab eval 19MAY96 revealed AST & ALT both inc;
Fever 101-102 right after in 6 hours of immunizations.  Lasted for 24 hours.
I administered the HPV vaccine (Lot: K001631 exp: Nov 6, 2016) to patient on September 8, 2014 in room. Patient was sitting on the exam table when I arrived to administer the HPV vaccine. I inquired if she would like to lie down on the exam table while I administered the vaccine due to past experiences of dizziness after HPV administration. Patient declined and reported that she did not like vaccines and would like to get it over with. Patient's mother was in the room at the time of the vaccine trying to provide distraction to the patient during while I administered the vaccine. After vaccine was administered I inquired how she felt and patient reported that she felt well. I then answered two additional questions patient's mother had and then proceed to leave the exam room with patient sitting on the exam table and mother in the room. About 1-2 minutes later a loud noise came from exam room. Myself, four additional nurses and Dr. immediately went to attend to patient. Patient was found on the ground with LOC for about 3 seconds. She became responsive with a complaint of head and neck pain. Ice, water, ADVIL (4 tsp PO) and rest for 20 minutes. Patient's mother reported that patient was stepping down from the step stool and then fell to the floor. I remained with the patient for 10 minutes and returned every 5 minutes for 10 minutes thereafter. Patient was able to speak with myself and her mother during this time. With the assistance of another nurse, we sat patient up to a chair where she denied any new pain or discomfort. Dr. then completed a brief head and neck exam. Patient appeared to be tolerating the exam with a complaint of neck pain. I stepped out of the room leaving patient safely sitting in a chair with Dr., another nurse and her mother. I was soon called back into the exam room by another nurse who then called the paramedics. With this second syncopal episode patient LOC for about 6 seconds and was then responsive and able to accurately answer questions. Her rate and oxygen were monitored (HR: 43 and O2: 100%). Patient appeared pale and was given oxygen via facemask on 0.5 L. Her color quickly improved and heart rate increased. The paramedics arrived shortly after and took report from Dr. and care of patient, who was then transported to ER for neck imaging.
Burning during urination; Headache; body aches and pains; joint fatigue; Very restless and difficult sleep; Very restless and difficult sleep; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 04Feb2021 08:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma but no food or medicine allergies but seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin, losartan, and metoprolol ER (extended release). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 14Jan2021 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other vaccine on the same date as the COVID vaccine. On 04Feb2021 22:00, the patient experienced headache, body aches and pains, joint fatigue, very restless and difficult to sleep first night. The patient experienced burning during urination the next morning (05Feb2021). No treatment was received for the events. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information of lot number has been requested.
Reports dizziness, fainted for few minutes. history of same symptom with venipuncture. BP: 71/42;  Repeat: 110/69 HR: 57 Sp02: 97% Refused to be transported to ER, refusal form signed. Seen and cleared by EMS
missed her appointment for the second dose; Right leg hurts; trouble walking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Right leg hurts), GAIT DISTURBANCE (trouble walking) and PRODUCT DOSE OMISSION ISSUE (missed her appointment for the second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Back surgery.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Right leg hurts) and GAIT DISTURBANCE (trouble walking). On 22-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her appointment for the second dose). On 22-Feb-2021, PRODUCT DOSE OMISSION ISSUE (missed her appointment for the second dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Right leg hurts) and GAIT DISTURBANCE (trouble walking) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Before receiving the vaccine patient was perfectly fine, but after some weeks her right leg started hurting and was in a lot of pain. patient had trouble walking and missed her appointment for the second dose on 22 Feb 2021. Patient went to emergency room (ER) where she received Z-Pack and a muscle relaxer, though it didn't help much. She's able to walk now, but leg still doesn't feel right.
When we called, he stated he had "flu" symptoms (nausea and laid around a couple of days). Fine after that..
Patient reports arm soreness for 3 days after receiving the vaccine on 12/31/2020. On 1/10/2021 patient reports that after taking a warm, longer than normal shower (due to shaving her legs) the injection site remained very red. Message left on 1/13/2021.
After the first dose my ears rang loudly for 5 days.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: TINNITUS (non-serious) with onset 24Mar2021 16:00, outcome "recovering", described as "After the first dose my ears rang loudly for 5 days.". Therapeutic measures were not taken as a result of tinnitus. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444904 same patient, different dose/AE.
arm pain; sick; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and sickness. On an unknown date, the outcome of the pain in arm and sickness were unknown.   It was unknown if the reporter considered the pain in arm and sickness to be related to Shingrix.  Additional details were reported as follows: About 45 hours before the reporting date, the patient received Shingrix.  The patient asked, the duration that the side effects start after getting the vaccine. The patient had only arm pain and was wondering if this adverse event was over or could get the patient sick.
Pt got hives around neck in complete circumference. Looked like mosquito bites.  Itchy
On Sunday, the 13th, I started to have scratchy throat; felt like sand in my throat every time I swallow. The following day, I started to have sinus congestion and sore throat and sneezing. Then the following day, the symptoms continued and I had to leave work early. That Tuesday, I lost my sense of taste and smell for a couple of hours but the next day they came back. I started to get better. Thursday I had high pulse and oxygen levels were a little high for the normal down to 95 and 96 and my usual is 100. I had a doctor I work with listen to my lungs and he couldn't hear anything. 15th I had a visit not with Primary care whoever was covering  that day, they prescribed me with a nasal spray. ER heart rate was still high and they did blood work; X-ray; EKG; rapid Covid test and PCR negative result; everything came out fine. No treatment. But diagnosis of Upper Respiratory Infection. I had another visit with dr after ER visit for follow up.I still have the cough.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: been taking Flovent, singular, Zyrtec and sertraline. Symptoms moderate and improving slowly as of 19Sep2022.; "Depression" (unspecified if ongoing); "obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flovent for asthma; Zyrtec for asthma; Sertraline for asthma. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2022) Negative, notes: I had negative COVID antigen tests on 11Sep2022 and 14Sep2022; (14Sep2022) Negative, notes: I had negative COVID antigen tests on 11Sep2022 and 14Sep2022; (17Sep2022) positive, notes: . I retested on 17Sep2022 when my son got a fever (previously negative as I had isolated from him) and the antigen test was positive; (08Sep2022) positive, notes: First positive PCR was on 08Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as COVID 19 Treatment from 08Sep2022 to "06Sep2022" (as reported).; Sender's Comments: Based on the available information in the case, the causal association between the event Covid-19 and vaccination failure  and the suspect drug BNT162B2 cannot be excluded.
Urinated lot of times; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinated lot of times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLYURIA (Urinated lot of times). At the time of the report, POLYURIA (Urinated lot of times) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-069622 (Patient Link).
She has contracted the covid-19 virus/tested positive for Covid; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (She has contracted the covid-19 virus/tested positive for Covid) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included End stage renal disease and Kidney transplant. Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (She has contracted the covid-19 virus/tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) ongoing since an unknown date for COVID-19 treatment, at a dose of 300 mg, 100 mg dose pack. At the time of the report, COVID-19 (She has contracted the covid-19 virus/tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urea: Result awaiting and Normal. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the patient was prescribed paxlovid for the treatment of COVID-19 and she was not able to swallow the pills because it could not be crushed or split. She further stated, it has been sometime since she had COVID so this would precautionary reason for her to receive paxlovid. It was not within 5 days treatment.
My son received the first dose of the HPV shot on 11/01/2019. Within a few hours,  he started feeling very week,  he developed a bad headache,  and a loss of appetite.  It is even worse on 11/02/2019. Today he won't get out of bed,  all he wants to do is sleep.  He is running a fever of 102, and has not eaten in two days.
Rash on back, sides and arms - Dr incorrectly diagnosed as Pityriasis Rosea on 1-2-07. Diagnosed as Lichen Planus 3-6-07. Recommended treatment drug Soriatan Acitretin which has possible severe side effects not being used at this time. This is in follow-up to report(s) previously submitted on 4/13/2007. Information has been received from a licensed practical nurse concerning a 69 year old male with benign prostatic hyperplasia, arteriosclerotic cardiovascular disease, osteoporosis, trigeminal neuralgia, hyperlipidaemia, dyspepsia, hypertension, and allergies to ANTACAND ("problem with is his head"), ACEON (lightheaded), ALTACE (vertigo), MAVIR (vertigo) PRAVACHOL (vertigo), and REMERON (sleep aberration) who on 14-DEC-2006, in the PM, was vaccinated with no improperly stored first dose of ZOSATAVAX (Merck) (lot # 654604/1406F). There was no illness at the time of vaccination. Concomitant therapy included AVODART, aspirin, LIPITOR, AMBIEN, TEGRETOL, SEPTRA DS, VIAGRA and clobetasol propionate. The patient developed a non-vesicular rash on his back 10 days after receiving the vaccination. The patient was referred to a dermatologist who first diagnosed pityriasis rosea and then dermined the diagnosis to be lichen planus. The patient was prescribed SORIATANE. The patient also had a decrease in facial hair. At the time of the report, the patient had not recovered. A product quality complaint was not involved.  Additional information was received from the licensed practical nurse who reported that on 17-DEC-2006, the patient developed a rash on his back, he had facial hair loss, and lichen planus. It was noted that the patient was also recently started on AVODART. The patient saw a dermatologist. The patient was found to have benign nevi (no treatment needed), lentigines/ephelides (not treatment needed), and lichen planus for which he was treated with SORIATANE 29 mg daily. The dermatologist made no comment regarding whether the lichens planus was related to vaccination with ZOSTAVAX (Merck). It was unknown if the patient recovered. No further information is expected.
4 x 4 cm firm swollen area at immunization site. This being upper left leg. Also a 2 x 2 cm area of erythema in the center of the area.
adverse reaction; injection site had turned red after 1st dose; headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (for 10 years ). Concomitant products included TIMOLOL for Glaucoma, ATORVASTATIN CALCIUM, ZOLPIDEM and LATANOPROST for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose). At the time of the report, ADVERSE REACTION (adverse reaction), INJECTION SITE ERYTHEMA (injection site had turned red after 1st dose) and HEADACHE (headache after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information reported as Denlafaxine (substitute drug).  Unknown treatment medication was reported for nausea.   This case was linked to MOD-2021-313718, MOD21-140857, MOD-2021-313629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up contains significant information, reporter information added, Patient information and medical history information added, Product information added, Concomitant medication information added, Adverse event added.
I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    The patient's past medical history included Prostatectomy (Patient got prostate removed 6 years ago and followed up immediately with radiation).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: 1.8 (High) High.   No concomitant drugs were reported. No treatment medications were reported.  Patient reported that the Prostate specific antigen reading was less than 0.01 for 6 years.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up document received. Added information about the start date of the event (prostate specific antigen increased).
19 Y/O MALE C/O NAUSEA FOLLOWING COVID VACCINE ADMINISTRATION. PT MONITORED FOR 30 MINUTES AND SYMPTOMS SUBSIDED. NO TREATMENT REQUIRED. VS WNLS.
Patient received MMR (measles, mumps, rubella) vaccine SQ right arm--where shot given, area developed a knot, reddened, swollen and tender, this started about the next day after shot, then 9-22-02 patient had an increased temp 101, went to Dr. on 9-24-02, diagnosis of cellulitis, given antibiotic dicloxacillin qid x 7 days
Patient came in complaining of localized reaction, red, swollen, limited to site, warm to touch. Patient denied fever. Advised patient that these can be normal reactions based on VIS, advised local minor first aid.
Morning after vaccine administration- approximately 6:00am pt stared off and husband could not communicate with her for a few minutes. Then a few minutes later she passed out at the breakfast table and hit her head on the table. She awoke when her head hit the table and her husband helped her to the couch, obtained her BP 113/72. No further adverse events. Pt scheduled to go to general practitioner on this date 8/30/18.
This spontaneous report was received from a nurse refers to a 74 year old male patient. No concurrent condition or medical history was reported. On 20-NOV-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose and route of administration was not provided) which had been exposed to temperatures outside of the recommended range (incorrect product storage). No concomitant therapy was reported. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
I developed a new onset of Bells Palsy on the right side of my face. It started the day before I was to be given the 2nd dose.
Pt appeared to faint after getting immunization, she had stood up and then appeared to be dizzy and unwell. Her boyfriend who was also there for an immunization and I were able to catch her before she fell, she was brought to floor in sitting position and I recommended she lie down, she was very pale but still coherent. We called store assistant manager who came to assist and he called paramedics to check her out. I stayed with her until paramedics came, they checked her out and determined she was ok and did not need further assistance. She was driven home by boyfriend once she was given the all clear and we all determined she was ok. Patient appeared to have a fear of needles. We called patient later in evening to check on her and she said she was doing fine.