chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 17Feb2021 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient had no other medication in 2weeks. No Known allergies were reported. Anti-viral details included Paxlovid for COVID 19 Treatment starting from 17May2022 to 22May2022. Paxlovid rebound 3 days after completing treatment. Zero symptoms after treatment. 3 days later runny nose, congestion, fever, fatigue, sore throat, and sneezing.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant and refers to a 2 patients of unknown age and gender. On an unknown date those patients were vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported) after being stored improperly. No adverse effects reported. Additional information has been requested.
Chilling/uncontrollable shaking first 7 hrs.  After that stopped it progressed to headache.  fullness/pressure feeling in head & ears.  teeth slightly aching (maybe from all the shaking).   Also,  10 to 12 hours in-I lost bladder control, but only when I stood up, it was never an issue when lying down.  That lasted about 10 hours.  After that issue subsided, I had diarrhea, although it seemed to be only digestive fluids as my stomach was empty.  It continued after I ate solids too. That lasted about 12 - 24hours.  Also had a slight numbness in tip of 2 fingers.  Continuing headache.
Hoarseness, dizziness, muscle aches, trouble breathing, coughing...10/30/2009 to present.
Large erythemic area 8 x 10 cm at injection site with central induration area 3 x 3 cm. Warm to touch. Told to apply ice, TYLENOL or MOTRIN for discomfort (evaluated 11/15/14).
sterile water was used to reconstitute the ActHIB instead of the 0.4% Sodium Chloride, no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ177AAB, Exp. Date 08-Feb-2021 via intramuscular route in the left thigh on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to wrong solution used in drug reconstitution.  It was reported that sterile water was used to reconstitute the Act-HIB instead of the 0.4 percent Sodium Chloride.  The patient had no side effects.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Pt reported to pharmacy the day after the immunization with a bumpy, elevated rash from the R deltoid region, down to the elbow. She reported severe pain, pruritis, and erythema. I recommended pt to use cold compress/ice pack at different intervals throughout the day, tylenol at correct dosing for pain, and also recommended to alternate between diphenhydramine cream and hydrocortisone cream throughout the day. I did not recommend diphenhydramine PO since pt is 77 yo, and reported NO systemic allergic rxn s/sx. Pt came to pharmacy this AM, with rash still present. No bumps present, but pain still present. Pt went to urgent care this AM, and PA reported pt had cellulitis, and prescribed Bactrim DS x 7 days.
After receiving the vaccine I was suppose to get my period within 3 to 4 days and I never had my period that month.  My period is very regular and lasts three to four days.  I just had the second vaccine on 5/17/2021 and should have my period today or tomorrow but have not yet menstruated.
A report has been received from a health professional concerning a 10 year old, female subject who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
PATIENT HAD TROUBLE BREATHING, GASPING FOR BREATH. UNCLEAR IF ALLERGIC REACTION OR PANIC ATTACK.
developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    patient was allergic to unknown historical drug.  The patient's past medical history included Appendicitis and Pericarditis. Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Batch/Lot No: Lot ER8731 Location of injection: Arm Left) on 09-Apr-2021 and Pfizer / BioNTech (Batch/Lot No: Lot EW0175 Location of injection: Arm left) on 03-Jun-2021. Past adverse reactions to the above products included No adverse drug reaction with Pfizer / BioNTech; and No adverse event with Pfizer / BioNTech.   On 11-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022 at 11:15 PM, the patient experienced TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.). At the time of the report, TASTE DISORDER (developed a constant plastic taste in my mouth/plastic taste comes back and gets progressively stronger.) had not resolved.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  patient did not took  any other medications/products within 2 weeks of starting COVID-19 treatment and the patient previously receive a COVID-19 Vaccine.   Patient after taking the second round of pills developed  a plastic taste, It can be distracted with food and other flavored things, but plastic taste comes back and gets progressively stronger.
CHILLS AROUND 02:00; HEADACHE AROUND 02:00; This spontaneous report received from a parent concerned a male of unspecified age. 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: not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced chills around 02:00. On 13-APR-2021, the subject experienced headache around 02:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache around 02:00, and chills around 02:00. This report was non-serious.
Pt vaccinated with Pneumovax 23/Influenza developed pain, swelling & erythema at injection site; chills & fever.
Breakthrough case of COVID, I had a headache, body ache, coughing, fever, chills, chest tightness, and fatigue I was prescribed PAXLOVID anti-viral medicine.
1st dose received 06/1/21, 2nd dose 07/19/21 (over 42 days)
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, male patient with no pertinent medical history reported. On 26-SEP-2012 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Concomitant medications included Hepatitis A Vaccine (manufacturer unknown) intramuscular in the left arm, dose not reported) and MENACTRA (intramuscular on the left arm, dose not reported) both administered on 26-SEP-2012. On 29-NOV-2012 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Diaphoresis; Dizzy/lightheaded; Increased anxiety; Chills; This is spontaneous report from non-contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration, on 18Mar2021, (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced diaphoresis, dizzy/lightheaded and increased anxiety. The patient also complained of chills and dizziness. The patient denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient received treatment as a result of adverse events experienced which included water, snacks and laying down. The patient had excellent response to treatment. The patient was stable to go home and was asked to follow up with primary care physician (PCP). The clinical outcome of diaphoresis, dizzy/lightheaded, increased anxiety and chills were recovered on 18Mar2021.   No follow-up attempts are possible. No further information is expected.
15 minutes after receiving shot, I started feeling itchy in many places. My face flushed red and my skin has red splotches on my upper chest.  I had just been released from the vaccination observation area, and I returned for additional guidance.  They told me since I drove out of observation, they could not do anything and I had to go to an urgent care center.  I phoned my regular doctor and the triage nurse in the office instructed me to take 2 Benadryl immediately. I drive to a pharmacy and took the Benadryl.  The Benadryl relieved the symptoms for about 2.5 hours and then they returned. I took 2 Benadryl every 4 hours until the itchiness stopped approximately 12 hours after receiving the shot.
Information has been received from a registered nurse concerning a 4 year old female with Down's Syndrome, coronary disease, penicillin allergy, Zithromax allergy and atrial septal defect (closed in May 2006) who on 20-AUG-2003 and 23-MAY-2007 was vaccinated with the first and second dose of varicella virus vaccine live (Oka/Merck) (Lot # 644565/1149M and 657408/0517U) SQ in the left thigh, respectively. Concomitant vaccinations on 23-MAY-2007 included the first dose of VAQTA (Lot # 654514/0304U) IM in the left thigh and second dose of M-M-R II (Lot # 64892/1028F) SQ in the right thigh. Prior vaccination included Hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On 25-MAR-2007, the patient experienced rash all over. On 28-MAR-2007, the patient came into the office with a rash all over. The patient was diagnosed with infected chickenpox and treated with Neosporin. The patient had a positive exposure at daycare. The patient did not have fever. The patient recovered from the rash all over and the infected chickenpox. Additional information has been requested.
I had a breast lump ectopy surgery was on October 19th, 2021 - 5 weeks post-surgery (3 weeks post shot) developed a hematoma at the lump site of my surgery.
This spontaneous report has been received from a 67 year old female physician via a field representative referring to herself. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On Monday,14-JAN-2019, the physician was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). It was not specified if the physician had previously received PNEUMOVAX 23 prior to the dose on 14-JAN-2019. On 22-JAN-2019 (reported as the following Tuesday), she went to the emergency room because she was swollen and red at the injection site on her left arm behind her deltoid all the way up to her wrist. She thought it was cellulitis. At the time of the report, the outcome of the event was unknown. No causality assessment was provided. Upon internal review, cellulitis was considered to be medically significant.
serious adverse event/ within 12 hours of receipt of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (serious adverse event/ within 12 hours of receipt of the vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient has been hospitalized due to adverse event.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt developed a local rxn one day after vaccine DTAP was administered. Also papular lesion developed on chest area.
Pt is an otherwise healthy 20 year old male who presents with 2 weeks of blurred vision in R eye.  The blurry vision developed suddenly 1 week after getting 1st dose of covid vaccine (moderna).  He was seen in ophthalmology clinic on 04/29 and diagnosed with R optic neuritis;    The patient reports that his blurred vision has not improved or worsened since onset.  It affects both his near and far vision in the right eye only.  He denies double vision, eye pain, headaches, nausea, vomiting, numbness, tingling, or weakness.  This has never happened before.  No recent illness including fever, chills, runny nose, cough, or sore throat.  Pt admitted to hospital.   Etiology of his optic neuritis is unclear, but possibility include demyelinating etiology (like clinically isolated syndrome). Infectious etiology was thought to be unlikely given no signs/symptoms of infection and reassuring lab workup.  No family history of similar symptoms reported, making hereditary optic neuritis less likely. Other considerations included other primary ophthalmological disease, although otherwise reassuring ophthalmological exam makes that less likely. Unclear association with COVID vaccination.
pt recv vax 6FEB97 & next day pt had temp & had sz;pt taken to ER t102.1;given Ibuprofen & transferred from ER to another hosp
The patient had a half dollar sized red raised area on right deltoid where Tdap injection was given.
Seizure at 4:30am. Fever has not stopped (102.00) even on TYLENOL and ADVIL.
DIZZINESS; NOT FEELING WELL; NUMBNESS ON THE LEFT SIDE/HAND, FACE AND LEG SOME TIME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced dizziness, not feeling well, and numbness on the left side/hand, face and leg some time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and not feeling well, and the outcome of numbness on the left side/hand, face and leg some time was not reported. This report was non-serious.
CC:Woke up next morning having a difficult time urinating.  He stated took it took him 30 minutes to urinate. Urine was Dk. green in color and he experienced pain when urinating. He also C/O intense soreness from Rt. shoulder to elbow region.  Unable to raise arm above head level.  Pain extended across his neck.   Mom said symptoms started at 8:30 am on 8/9/06.  Came into Health Dept. at 11:00 am on 8/9/06.  Rt. Deltoid and arm checked, no redness or swelling noted, no warmth noted. Lt. Deltoid area looked normal and he was able to move left arm without problems.   Temperature was checked and it was  99.5 F per ear thermometer.  Child said it hurt to move Rt. arm in any direction and it hurt when it was touched.  Sent to physician.  Dr. told mom that Advil should be used every 6 hrs. for pain as needed.  His urine was checked at doctors office and it was clear and normal on a dipstick.  Doctor said to mom that he thought this was a adverse reaction to the vaccine. I called mom on 8/10/06 to see how her son was doing.  She said he was improved, pain, fever, difficulty and pain in urination had resolved.
Parents noticed large blister/bulla rash around injection site with redness 2 days after administration.
migraine h/a on waking; migraine suffer; sx not relieved by usual medication; 1AUG also had abdo cramping & fever; feels really lousy but sx seem to be resolving; 14SEP93 f/u: 2 yr booster dose p/primary series; condition resolved
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 4-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2022 at 11:00 as dose 1, single (Lot number: FT9142) at the age of 4 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "given incorrectly...The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syringe and not in the vial."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 15Jul2022 at 11:00, outcome "unknown", described as "it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. It was mixed in the syrin"; ABDOMINAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown"; PYREXIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "fever 101-102"; DYSPHONIA (non-serious) with onset 19Jul2022, outcome "unknown", described as "hoarse voice"; OROPHARYNGEAL PAIN (non-serious) with onset 19Jul2022, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain, abdominal pain, pyrexia, dysphonia.  Additional Information: Caller was an office manager calling on behalf of a pediatric clinic. The product was given incorrectly. Caller was not sure if she had time to do a report. The mother of the patient was getting antsy and had already been there for 30 minutes. Caller clarified that she did not have time to do a report at that time. Caller clarified how it was given incorrectly. The nurse drew up the diluent, 2.2ml, into a syringe and pulled 0.2ml from the vaccine vial into the syringe. The patient did not receive prior vaccinations within 4 weeks. It was mixed in the syringe and not in the vial.   Follow-up (30Aug2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported in response to HCP letter sent. Updated information: Vaccine Information (dose number, lot number, route of administration), information on concomitant medication, lab test, treatment received, vaccine administration facility information and new adverse events added.
For two days I had severe flu like symptoms, chills, fever at 103, nausea, headache, overall body ache
Sore arm, aches, tired, headache for about 48 hours Nausea for 2 hours
Swelling, redness, pain.  Entire deltoid area was swollen + red warm compress, Benadryl and Ibuprofen given w/ good response decrease swelling.
This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 3 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.