chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (exact dose, route of administration, lot# and expiration date were not reported) for routine immunization. On an unknown date, after the patient received GARDASIL 9, she experienced body aches and a fever. The patient did not seek medical attention. It was unknown if a treatment was given for the events. The outcome of the events and causality assessment were not provided.
Body aches; Fever; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiry date were not reported) via an unspecified route of administration on an unknown date in 2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. This report was not related to a study or programme. The patient experienced fever and body aches on an unknown date in 2021. She asked if it was normal to have side effects from the first vaccine dose 5-7 days after having the vaccine. She also asked if she should just stay home and wait it out or get tested for covid. She wanted to know in clinical trials how high fever did participants get after a dose of the covid vaccine. She asked If hypothetically she go to her doctor and get tested for covid, and she tested positive, so how long would she have to wait to get her second dose. She asked how long it takes to get side effects from the vaccine, if it was common to get side effects 5 to 7 days after the first Pfizer BioNTech covid-19 vaccine dose.  She was advised that she would be transferred for further assistance. Investigation assessment was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient stated that within 1-2 hours of vaccination she experienced uncontrollable shaking and was very cold for a 30 minute duration. She feels it was due to the vaccine.
Lightheaded and dizziness for 1 and a half day, pain in the right arm for a few days
C/o lightheadedness, frontal headache 4/10,numbness/tingling of left fingers only, bilateral lower extremities heaviness mild from hips down to feet, "states I just feel off".  Ambulated  short distance to parametics handoff. BP 132/64 HR 70,O2 98%, alert and  oriented x3, denies itchiness,hives, difficulty swallowing. Vitals remaining stable over 45 minutes of evaluating, with numbness in left hand subsided, H/A remains at 4/10, able to stand with remaining heaviness. Patient has declined transport to the ED, although has called for ride home(awaiting).
Patient felt like throat was tightening and heart rate was increasing 15-20 minutes after the Moderna Covid-19 vaccine.  She said the symptoms were similar to her allergic reaction to injectable Bactrim.
several pt who recvd 3 doses of Engerix-B did not respond;
Patient was fully vaccinated and tested positive for COVID today; Patient was fully vaccinated and tested positive for COVID today; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Mar2022, outcome "unknown" and all described as "Patient was fully vaccinated and tested positive for COVID today". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Mar2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hive like reaction that persisted for 1 week in area below deltoin and above elbow
Maculopapular rash in patches over trunk/extremities--approx. 5 mm patches--some w/crusted center.   Diagnosis:  generalized vaccinia. Treatment:  Allegra, Pepcid.
Had the shot on 3/17 and about a week later i started to feel dizziness.  I had bouts of that off and on more on than off up until had my second shot on 4/26/2021.  I still have bouts of dizziness off and on still more on than off.  It's almost like you feel yo constantly have had 1 too many drinks and are tipsy
A non-serious spontaneous report of gave full dose of H1N1 LAIV in one nostril was received from a registered nurse concerning a 12-year-old female. No relevant medical history was reported for this patient. On 18-Nov-2009 the patient inadvertently received 0.2ml of H1N1, Intranasal into a single nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Congestion, runny nose, cough, head ache, body ache, dizziness, difficulty breathing, weakness.
Sensorineural hearing loss (SNHL) of left ear. Started on morning of 3/4/2021. On-going - Sudden idiopathic hearing loss, left ear On-going - Tinnitus of left ear  Dr. Notes - 3/26/2021 No subjective improvement in hearing loss and nonpulsatile noise since completing oral steroids and having undergone 3 intratympanic injections Is interested in completing the fourth injection as discussed before reassessing, this was done today without any issues Independently reviewed MRI IAC results. Shows inflammation of the left cochlear nerve without mass lesion. Radiology also felt that there was inflammation of the 7th cranial nerve as comparison with the right. Discussed these findings with patient and provided copy of report.
Headache, Body Aches, Fever (102.7), Tiredness. Tylenol every 4 to 6 hours, Fluids.
Shingles ever since second injection of Pfizer vaccine on 3/17/2021
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 12-month-old male patient who received BOOSTRIX (batch number 3HG7R, expiry date unknown). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration, vaccine underdose and wrong vaccine administered to be related to BOOSTRIX. Additional information received on 26 September 2014: The BOOSTRIX dose was administered inadvertently.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 19-OCT-2012 11:01, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
PATIENT HAD INJECTION SITE REACTION (RED, INFLAMMED, HOT, PUFFY) AND IT SPREAD DOWN NEAR HER ELBOW. STARTED THAT NIGHT AND RESOLVED IN A FEW DAYS ON OWN WITH ONLY OTC IBUPROFEN.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with their first two doses of GARDASIL or GARDASIL 9 "one year apart", (route of administration, lot # and expiration date were unknown). The nurse also reported that unspecified patients who receive either GARDASIL or GARDASIL 9, fainted after receiving the dose. At the time of reporting, the outcome of syncope was unknown. The causal relationship between the syncope and the vaccination with GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Vaccine administered 9/14/10, pain & firmness in arm that evening, redness & itching yesterday, increased erythema today approximately 8x10cm, well-demarcated. No fever.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be 1) 19-NOV-2014 and  2) 08-AUG-2014. [Dates as reported. Await clarification of the year for these vaccines]. It was also documented for this patient (Also finish Hep A series). No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
This is a spontaneous report from a contactable pharmacist who reported the same event for two patients. This is the first of two reports. A female patient of unknown age and race/ethnicity received on 02Mar2017 PREVNAR 13 (lot number R48403, Expiration date: Apr2018, NDC#00005197102) at 0.5 ml single dose to prevent infection by pneumococcus. Concomitant medications and medical history were not reported. In Mar2017, the patient experienced a little bit of red area at the injection site. Outcome was not recovered. Sender's Comments: Linked Report(s): US-PFIZER INC-2017109175 same reporter/drug/event different patients.
5 days p/vax pt devel a bump on her upper lip & small bumps on tongue.
Fever 103.1, felt "sluggish", myalgias symptoms + 2 days.  Treatment - OTC TYLENOL.
24 hours later - fainting, postural hypotension. Treatment: patient advised to take fluids and keep hydrated.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included GERD since an unknown date, Hypertension since an unknown date and Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Lisinopril). Concomitant products included ALLOPURINOL, PROCHLORPERAZINE MALEATE, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM DS), FLUTICASONE PROPIONATE, METOPROLOL TARTRATE, ONDANSETRON HCL, PAROXETINE HCL, ROSUVASTATIN CALCIUM, LANSOPRAZOLE and OBINUTUZUMAB (GAZYVA) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Employee called stating she received the Pfizer COVID-19 booster vaccine on 12/11/2021 and is now experiencing symptoms. The symptoms include sharp chest pain that comes and goes 5/10 on pain scale, and difficulty breathing when taking a breath in. Advised employee to go to the ER or urgent care to be seen for symptoms.
A sharp stinging headache (just like having COVID-19); Severe arm pain at injection site; Fatigue; Body aches; Hot and cold spells; A consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7; Face and sinus pain; Face and sinus pain; loss of taste/smell short period; loss of taste/smell short period; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0169), via an unspecified route on 16Apr2021 at 14:30 (at the age of 49-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included had COVID-19 on 23Nov2020, heart failure caused by COVID-19, chronic back pain due to accident that caused a Pain Pump to be administered with Bupivacaine. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8730), via an unspecified route on 26Mar2021 at 08:30 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021 at 11:30, the patient experienced a sharp stinging headache (just like having COVID-19), severe arm pain at injection site, fatigue, body aches, hot and cold spells, a consistent fever of 101.1 that lasted on and off for 2 days (more than 8 hours) that peaked at 102.7, Face and sinus pain, loss of taste/smell short period. The patient did not received treatment for events. The patient underwent lab tests and procedures which included covid-19 was positive on 23Nov2020, fever was 101.1 on 16Apr2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
rapid heart rate; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills). On 30-Mar-2021, HEART RATE INCREASED (rapid heart rate), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medication provided treatment included pain reliver
I received my first dose of cover vaccine on February 20 and started having shooting pain under my right arm( The arm I received the vaccine), I went to emergency room and begged my pcp to see me and the ARNP said it's covid related. so I received my second shot on my left arm. I had my right under arm pain for a month and five days. then it stopped. But on April 15 my left under arm started to hurt and immediately my right underarm started hurting too. I saw a doctor he examined and said both  arms axillary lymph nodes are swollen. he gave me anti bionics, I am still in pain.
Within 30 minutes arm became swollen, red, itchy and very hot. Within 60 minutes arm was swollen to elbow. Sent to ER, given steroid injection and Benadryl for prn use.
Patient had a reaction to the vaccine. After his second dose of Pfizer was administered, patient broke a sweat, his pupils dilated, his heart was beating fast, and his breathing was altered. He also started feeling dizzy. Patient was given water and icepacks were placed on his forehead and neck. 911 were called. Upon arrival, they took his vitals. Everything was normal O2 97%, Temp: 36.1 C, BP: 121/80, HR: 73. Patient was not transferred to the hospital.
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 16 year old male. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced product administered to subject of inappropriate age, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Patient was brought in by mother. Left Deltoid where shots were administered had localized redness was warm to touch, site was about 5x4 in length and width. Per mom no fever or sign of illness.  Was told to take IBU for pain. A circle was drawn on patients arm over the area, Mom was told to watch the site and if it gets bigger or if other illness occurs to call the office or go to the ED. Follow up will be made on 06/15/2017 by phone call if mom has not returned to office.
Short breath; Sever stomach cramps; Sever stomach cramps and Burning; Body aches; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 (Lot number: EW0180) at the age of 67 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC; FLU VACCINE VII, administration date 15Sep2021. Past drug history included: Augmentin, reaction(s): "Known_allergies: Augmentin", notes: known allergies: Augmentin. The following information was reported: DYSPNOEA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Short breath"; ABDOMINAL PAIN UPPER (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Sever stomach cramps"; DYSPEPSIA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Sever stomach cramps and Burning"; PAIN (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Body aches"; NAUSEA (non-serious) with onset 24Sep2021 13:00, outcome "not recovered", described as "Nausea". BEACHES (non-serious) with onset 24Sep2021 13:00, outcome "not recovered". Therapeutic measures were not taken as a result of dyspnoea, abdominal pain upper, dyspepsia, pain, nausea and beaches. No Covid prior vaccination. No Covid tested post vaccination. The patient did not provide information to Other HCP regarding the reported adverse event(s) with the use of the product. Additional information: The patient was not pregnant during the vaccination. Patient did not receive treatment for the event. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Patient was alert and oriented leading up to injection.  Upon completion of immunization, patient lost consciousness and went in and out several more times over next 5 minutes.  Patient was able to regain consciousness, drink water, and was checked out by emergency personnel where blood pressure was normal. Patient was able to walk out of pharmacy with no additional interventions needed. Patient has had fainting spells with immunizations before per mother, which were disclosed AFTER immunization was given.
swollen up and it still kind of hard so; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization; Bnt162b2 (Dose 2, Single), for Covid-19 Immunization; Bnt162b2 (Dose 3 (Booster), Single), for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen up and it still kind of hard so".  Additional information: Consumer stated that when the patient got the injection, her arm swelled up real bad and it had not gone away at the time of report. It was still swollen and she had it 20Oct2022. She got the Pfizer (Confirmed as COVID-19 vaccine), number 4. Reporter stated that it was in the muscle when she got it but it was still swollen up and it still kind of hard so, it was probably since 20Sep and it was swollen up hard. Reporter asked what they could regarding the event. Reporter stated that Pfizer 30 mcg/0D 3 ml Inj Pfizer. It came through on the shot when she got it (not clarified further)."  No follow-up attempts are possible. No further information is expected.
Full body itching. Began in the morning upon rising.  Continued all day.  There was no rash and no hives.  Continued throughout night.  Used Calamine lotion.  It was semi-effective for a short duration.  If scratched, the skin would turn blotchy and red.   24 hours later purchased OTC antihistamine which provided relief for 24 hours.   I took the antihistamine again the second 24 hours.  The itching didn't return after that.
This is not really an adverse event.  I gave the pediatric Pfizer instead of the adult.  The patient did not have an adverse effects yet
pt recvd vax 3JUN95 & 16JUN95 pt devel rash on elbow of the opposite arm which inj had been given;rash was 3 inch circumference discoloration;depigmented area of pt rt arm
SWOLLEN LYMPH NODE; ACHE ALL OVER; ANXIETY; ARM PAIN; CHILLS; TIRED; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced ache all over. On 09-APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced arm pain. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ache all over, and fever on APR-2021, and arm pain, chills, tired, and headache on 10-APR-2021, had not recovered from swollen lymph node, and the outcome of anxiety was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.