chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual cycle; enlarged lymph node/Painful to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 12:00 (Lot number: EN6201) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension (ongoing).  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 11Mar2021, outcome "recovered" (13Mar2021), described as "enlarged lymph node/Painful to touch"; MENSTRUAL DISORDER (non-serious) with onset 16Mar2021, outcome "recovering", described as "Menstrual cycle". Therapeutic measures were not taken as a result of lymphadenopathy, menstrual disorder.    Additional information: -Enlarged lymph node in groin area for 2 days. Painful to the touch.  -Menstrual cycle affected. started cycle early. 4 month later went almost 2 months without cycle. Cycles are shorter now.  -My workplace required our employees to be vaccinated. All employees received Vaccine at same location. Many have said it has affected their cycle too. Some went from having menstrual cycles to not having them. Some went from not having menstrual cycles to having regular, painful, heavy ones.  No follow-up attempts are possible. No further information is expected.
I am not aware of many of the details. We were just told the patient went to the emergency room after a couple of hours because he could not move his arm and he had lower blood pressure.
Fever, chilled and no appetite when waking in the morning. Took Tylenol and rested. Okay by the evening.
Zoning out, Drooling, unable to talk, extremity uncoordination. Information from 60 day follow-up report states: Seizures resolved. Pt continues on medications.
Information has been received from a Licensed practical nurse concerning 5 female patients aged 14-15, who were vaccinated with Gardasil vaccine. Subsequently the patients fainted, this "happened at all 3 doses not just one in particular". Unspecified medical attention was sought. All continued with therapy. The patients recovered, "all were ok". This is one of several reports received from the same source. Additional information has been requested.
no adverse event. vial of pediatric pfizer was not diluted prior to administration. patient received 0.2ml
feel prolonged and intense palpitations; prescribed a 48 hour Holter monitor which showed 15% of the time was with PVCs; This is a spontaneous report received from a contactable consumer (Patient). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0181) via an unspecified route of administration in left arm on 19Jun2021 at 14:00 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. Medical history included bee sting allergy and palpitations (I have had minimal palpitations for years) . The patient previously took sulfa [sulfanilamide] and experienced drug hypersensitivity. The patient was not pregnant at the time vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multi vitamin. Patient did not have COVID prior to vaccination and it was yes covid tested post vaccination. It was reported that a few days after the first vaccine, I started to feel prolonged and intense palpitations. I have had minimal palpitations for years, but never the duration or intensity of these. About 2.5 weeks after dose 1, they hit the max intensity. My doctor prescribed a 48-hour Holter monitor which showed 15% of the time was with PVCs. The patient underwent lab tests and procedures which included Holter monitor (which showed 15% of the time was with PVCs) on Jun2021,sars-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab, sars-cov-2 test: negative on 28Jul2021 other (Saliva test). Patient did not receive any treatment for the events. Patient visits emergency room and physician office for the events. Outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Husband said pt said heart felt diff-pt said legs felt weak,faint and felt like she needed to use her inhaler-called 911-had her lay down-since felt faint-lady at 911 said she could use inhaler and not to give anything since paramedics were almost there-pt bp rate varied
This spontaneous report was received from a Medical Assistant regarding multiple unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On multiple unspecified dates from 18-JAN-2016 to 28-JUN-2016, the patient was vaccinated with improperly stored ROTATEQ (dosing details, lot# and expiry date not known). The administered vaccines experienced a temperature excursion of 51.1 degree Fahrenheit for 18 hours 30 minutes. There was no previous excursions. The call was because of a "data logger". No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Racing heart(panic attack feeling), flush feeling in skin, intermittent body aches. Insomnia,
Fever, chills, vomiting, diahrea, severe arm and shoulder pain.  I was given antibiotics and pain meds.
body ache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Reporter contact information was updated.
Patient fainted.  She had pulse and was breathing.  She was in and out (eyes opening and closing).  Customer nearby was an EMT and assisted before 911 arrived.  Patient was shaking for a few seconds.  She also vomited.
Shortly after receiving the vaccine the patient began to feel a tingling sensation in her bottom lip.  The lip also felt swollen to the patient but no swelling was visible to the staff.  The patient mentioned to the staff that the same thing happened with her first Moderna vaccine and we gave her a Benadryl.  The patient began to develop a metal taste in her mouth.  Clinical staff took the patients vitals which were all within normal range.  The patient was given 25 mg of Diphenhydramine.  The patient's symptoms began to improve and after sitting for 30 minutes, the patient was ready to go home.  Last time she went home and took a nap and woke up feeling better.  She stated she was going to go home and do the same thing.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 14-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
MOTHER PHONED OFFICE WITH COMPLAINTS OF RIGHT ARM WHERE IMMUNIZATIONS WERE GIVEN EARLIER TODAY WAS VERY RED, WARM, AND EDEMATOUS. INSTRUCTED TO PLACE COOL COMPRESS ON IT. INST TO CALL BACK IF NO IMPROVEMENT. PHONED LATER TO SAY NO IMPROVEMENT,BROUGHT IN FOR MD TO CHECK. ARM VERY SORE, RED, AND EDEMATOUS. INSTRUCTED TO USE ICE PACK 20 MINS TID. PT RECIEVED DTAP,IPV, AND MMR IN RIGHT ARM AT 1 IN. SPACES. MMR GIVEN SQ.
48 hours after receiving MMR, patient experience soreness, swelling and erythema at injection site. Patient sought medical care on 10/08/2002 and placed on PO antibiotics. Returned to DR on 10/14/02 for further treatment.
rash since vax all over pt is  is RH negative;hosp should have waited 4 to 8 wk;
Sore arm in shot location (both shots); This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A female patient of an unspecified age (Age: 75, Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown) via intramuscular route of administration on 13Feb2021 as dose 2, single for COVID-19 immunization. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced sore arm in shot location and headache. The patient medical history and concomitant medications were not reported. The patient experienced sore arm in shot location on an unspecified date in 2021. Patient would like to be part of 3rd dose Covid19 vaccine trials if possible. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022; No Adverse Event; Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine was given to 6 Pediatric Patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and was administered on 5-Nov-2022).    No concomitant medications were provided.  It was reported that reporter called in to report that an expired Moderna Covid-19 Vaccine was given to 5 Pediatric patients ages 6 months and older.  Vaccine was given on 05 Nov 2022 around morning time.  No adverse event reported from any of the patients .  Affected vials were individual ones with size of 2.5 ml.  Vial was initially stored in the refrigerator on 29 Sept 2022 and did not undergo temperature excursions.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669845 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669845:Same reporter
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with the first and second dose of GARDASIL (Lot # and expiration date unknown), dose and route of administration were not reported. It was also reported that on an unspecified date that the patient was vaccinated with the third dose of GARDASIL 9 (Lot # and expiration date unknown), dose and route of administration were not reported. No adverse events were reported. Additional information has been requested.
The day after he got the influenza vaccine (10/18/23), he was sore in the muscle where it was given but didn't really have any major issues. Mom noticed last night it looked a little swollen. The following morning when he woke up the entire arm appeared swollen from the injection site down to his wrist. He has no pain, free range of motion and there was no redness really noted by mother.   Patients left arm from the deltoid to wrist is edematous generally. The musculature is less well defined compared to the right arm as well. Patient has no pain and has full range of motion at the left shoulder, left elbow and left wrist. There are good pulses in the ulnar and radial sides of the arm near the wrist. Good capillary refill of the fingertips.
Rec'd Engerix-B on 8JAN90 & 2MAR90. p/second vax experienced an acute flare-up of her arthritis which required w/medication (unspecified).
30APR93 820AM OK no problems p/#2 IPV; 6MAY93 9AM clinic notified that on 30APR93 930AM devel pain rt & lt posterior lumbar area more so on right; had some edema hands, etc; did drink a lot of fluids; said had dec kidney output;
3/28/21 STARTED WITH HEADACHE - INCREASING IN SEVERITY ON 3/29/21, WITH PAIN BEHIND THE LEFT EYE. WENT TO ED ON 3/30/21 FOR BLURRED VISION IN LEFT EYE. TREATED FOR MIGRAINE, DISCHARGED.  WENT TO HER OPTHALMOLOGIST, DIAGNOSED WITH LEFT OPTIC NEURITIS. RETURNED TO ED FOR MRI OF BRAIN AND OPTIC NERVES, DIAGNOSIS CONFIRMED. TREATED WITH IV SOLUMEDROL AND ORAL MEDROL. PATIENT'S 7 MONTH OLD DAUGHTER AT SAME TIME DIAGNOSED WITH CROUP (VIRAL ETIOLOGY NOT IDENTIFIED). PATIENT IMPROVING POST STEROIDS.
Pt developed feelings of numbness in legs, backache and neck pain 3-4 wks post vax. It was explained to her that these symptoms were not side effects of this TD booster, and if there was a reaction, it would have occurred within 24 to 48 hours.
Child had grand mal seizure 11/13/2009 per parent. 11/19/09 DC summary and hospital records received for dates 11/9/09 to 11/10/09.  DX: partial complex generalized seizure disorder. Pt. presented per parent w/ unprovoked seizures. Pt parent states first on 11/8 pt. began twitching, unresponsive, pt taken to ER DX: status epilepticus.  Pt had additional seizure in ER. Assessment: several seizure episodes seen in ED prior, script given, not filled. Seizure occurrence again, parent brought to ER, pt admitted.
This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 82-year-old male patient who received SHINGRIX. Concurrent medical conditions included osteoarthritis and fusion lumbar spine. Concomitant products included AVODART, Aspirin, Pravastatin, CELEXA and NEXIUM. In February 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site discomfort and injection site swelling. On an unknown date, the outcome of the injection site discomfort and injection site swelling were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site discomfort and injection site swelling to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's wife. The patient received SHINGRIX on the left arm subcutaneously instead of intramuscularly, which led to incorrect route of vaccine administration. Less than a year, after receiving SHINGRIX, the patient experienced injection site discomfort and injection site swelling. The symptoms lasted about 24 hours before resolving. On 25th April 2018, the patient received the 2nd dose of SHINGRIX. The reporter did not know if it was administered subcutaneously or intramuscularly and did not report any adverse events following the 2nd dose of SHINGIRX. This case has been linked to the case US2018092508, reported by same reporter (husband's case).
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 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: other medical history: High cholesterol; "Known allergies: Sulpha" (unspecified if ongoing), notes: Known allergies: Sulpha. Concomitant medication(s) included: ATENOLOL, start date: 01Jan2010; ATORVASTATIN, start date: 01Jan2010, stop date: 19Jan2023. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Antiviral COVID 19 treatment Paxlovid start from on 21Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extreme dizziness when rolling over or standing up or laying down with eyes closed lasting for 15-20 seconds. Checked blood pressure and within normal range 130/80 with oxygen level at 92  Symptoms are beginning to lessen, no treatment  No treatment, continues to occur but symptoms are beginning to lessen.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.  No temperature excursion for vial.  HCP mentioned that there were 14 patients instead of 18 because of some duplicates. 14 patients were affected (4 of which received both dose 1 and 2 from affected lot). None of the patients have reported adverse events.   This case was linked to MOD-2021-369455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up contains updated Narrative and Reporter's contact details. On 05-Nov-2021: Follow up contains patient doesnot reported any adverse event after receiving dose 2.
After 10 min of the first  Vaccine, the Pt stated feeling itching on arms. The Pt was alert and no trouble breathing. Benadryl 50mg IM was given to right deltoid.  911 was called,  the Pt was able to sit on the stretcher and taken into the ambulance.
Low grade fever, tongue swelling, facial redness, pain at injection site, redness to face and arm (right) treated with TYLENOL and MEDROL dose pack.
Following immunization for puncture wound developed bilateral flank pain without fever, chills, dysuria. Flank pain has steadily worsened over past three days. Arm at injection site asymptomatic.
This spontaneous report as received from a Certified Medical Assistant refers to an unspecified number of unknown age. On an unknown dates the patients were vaccinated with a improperly stored dose of RECOMBIVAX HB, (route, dose, strength, lot # and expiration date was not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to a 5 week old patient (unspecified gender). The patient's medical history and concurrent conditions were not reported. On an unknown date, the 5 weeks old patient was vaccinated with RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018) (route, dose number information, dose, frequency and concentration were not provided) and with ROTATEQ orally, (lot # L035508, expiration date 12-MAY-2017) (dose number information, dose, frequency and concentration were not provided). Concomitant medications were not reported. No Adverse effects were reported. There was no product quality complaint (PQC) reported. Additional information has been requested.
First dose was giving to patient who is 17 years old.  Second dose is given today.  Patient didn't have any reaction from the 1st.