chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female with no pertinent medical history or history of drug allergies or reactions who on 31-JUL-2007 was vaccinated intramuscularly with the first dose of GARDASIL (lot no. 655849/0263U).  There was no concomitant medication.  On 15-AUG-2007 and 01-SEP-2007, the patient experienced a seizure.  On 01-SEP-2007 the patient was taken to the emergency room.  The patient was also taken to see a neurologist where she was diagnosed as having generalized seizures.  An electroencephalography was performed (results not reported).  At the time of this report, the outcome was unknown.  Generalized seizures were considered to be other important medical events.  Additional information has been requested.  10/16/2008 ER record received for 9/1/07 with DX: Seizure-new onset. Pt was sitting at home when pt began staring up and shaking with eyes rolled back in the head. Witnessed by family. Post-ictal upon arrival. D/C for outpt f/u
Felt dizzy within 15 mins after vaccine no loss of consciousness. No N/V, sinus good and equal sight. so x3. BP 120/80 complaints resolved with five minutes of rest.
Body aches, fatigue, cough with phlegm that started that 3 days after vaccine administration.
Information has been received from a physician concerning a male who, on an unspecified date, was vaccinated with Zostavax.  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently, three days after the patient was vaccinated, he developed shingles.  The patient was examined in the physician's office, but no details were available.  No further information is available.
SORE ARM; FEVER; REALLY BAD HEADACHE; BODY ACHE; JOINT ACHE; NAUSEA; DIZZINESS; CHILLS; LOW ENERGY; This spontaneous report received from a consumer 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced sore arm. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced really bad headache. On 05-MAR-2021, the subject experienced body ache. On 05-MAR-2021, the subject experienced joint ache. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced dizziness. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced low energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, fever, really bad headache, body ache, joint ache, nausea, dizziness, and chills on 07-MAR-2021, and low energy on 08-MAR-2021. This report was non-serious.
FacialSwelling,PalatalPetechiaeaswellasPetechiaeonBuccalMucosaandgumline.Feverof100.8.AtthatpointpatientadvisedtotakeTylenolExtraStrengthbyPharmacist.AsofMay10,2022,redspotshavedecreasedinsizeandnumberbutcontinuetocomeandgo.Patientcomplainsoflumpinessincheek.FollowingtheAugust19,2021vaccine,bloodwork.requestedbyOncologistrevealedadrasticdecreaseinpatient'sCD3count.PriortoavaccineonAugust,theCD3counthadbeennormal.SinceAugustvaccineCD3hasneverreturnedtonormallevels.CD3cellswereonly618onAugust26,2021bloodtestperformedatLabsandthenfellfurtherto509on12/21
Urticarial rash locally to site adjacent to site of vaccine administration, not to vaccine site. Benadryl administered, infant playful. No further compromise. (MMR vaccine site).
Initial reaction - Fatigue and Nausea that lasted 2 weeks.  Arm pain started the day after the vaccine and lasted 5 days.  Exactly one week after the injection (4/20) I developed a swollen lump on my arm near the injection site that lasted about 5 days.  Also developed a rash at the one week point that lasted about a week.  Rash was intensely itchy and did feel better when I started using Benadryl Gel about three days after it began.  Nausea and general not feeling as well as I'd have liked lasted 3 weeks total.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX. Concomitant products included CRESTOR, Metformin and terazosin. On 28th February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced chills, lethargy, fever, tremor, feeling hot, pain and feeling bad. In March 2018, the outcome of the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad were recovered/resolved. The reporter considered the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad to be possibly related to SHINGRIX. Additional information was received as follows: The lot number and expiration date was not reported for SHINGRIX. The patient reported that he could not recall the pharmacist whom administered SHINGRIX vaccine. After receiving the vaccine later that night the patient had fever, lethargy and was feeling bad. The patient described feeling bad as chills, shaking, hot and soreness. Four days after receiving injection, all events fully were resolved, no exact dates were provided. The reporter denied any hospitalization for treatment of events reported.
Abnormal bleeding / Menstrual cycle began 4 days early; heavy blood clots / Menstrual cycle began 4 days early; This is a spontaneous report received from a contactable consumer. A 35-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #ER8730) via an unspecified routed of administration in arm left on 26Mar2021 05:00 PM at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 29Mar2021 the patient experienced abnormal bleeding with heavy blood clots and menstrual cycle began 4 days earlier (less than 72hours after second vaccine). Adverse event start time was 10:00 AM. The events were resolving at the time of report. No treatment was received.
Myositis at site of injection - swelling, pain and inability to walk in that leg. Myositis worsened 10 days after the vaccination.
Flu-like symptoms; Cold symptoms; tested positive for SARS-COV-2 infection; tested positive for SARS-COV-2 infection; muscle and body aches; muscle and body aches; loss sense of taste; Congestion nasal; Sore throat; Loss of smell; Sinus pressure; Headache; general fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EJ1685, via an unspecified route of administration on 17Dec2020 16:00 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient got the COVID Vaccine and the day after, was exposed to the virus, got sick right away and tested positive for the virus. The patient stated that she got vaccinated around 4pm, 17Dec2020. She was exposed to the virus by the same coworker twice on 18Dec2020 and then the next week, she believed, on 22Dec2020, the coworker tested positive for COVID. Patient stated that her symptoms started 24Dec2020. She did not think she had a fever as she did not feel feverish. She had flu like symptoms from an unspecified date with muscle and body aches from 25Dec2020. She lost her sense of taste and smell from 25Dec2020. She had cold-like symptoms from an unspecified date with congestion nasal and sore throat from 25Dec2020, sinus pressure and headaches from 24Dec2020. She had general fatigue from 24Dec2020 for a while. Patient had not had another COVID test since the one she had 28Dec2020, when she tested positive for COVID. She became symptoms-free on 03Jan2021. Patient was asking should she still get the 2nd dose of the COVID Vaccine. She was also concerned about the reaction her body was going to have to the vaccine after being sick. The patient had recovered from Flu-like symptoms and Cold symptoms on an unspecified date, recovered from muscle and body aches on 29Dec2020, recovered from loss sense of taste and loss of smell on 31Dec2020, recovered from congestion nasal, sinus pressure and headache on 03Jan2021, recovered from Sore throat on 01Jan2021, recovered from general fatigue on 02Jan2021. And outcome of "tested positive for COVID after receiving the COVID Vaccine" was unknown.
5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion; The caller states that 5 patients received vaccine that experienced excursion in the refrigerator; No adverse reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered the Moderna Covid 19 vaccine after it suffered a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (The caller states that 5 patients received vaccine that experienced excursion in the refrigerator).    No concomitant medication was reported by reporter.  Vial was in refrigerator during temperature excursion. Lot number 060A22A had 2 unpunctured and 1 punctured vial with expiry date 28-Aug-2022, lot number 013B22A had 1 punctured vial with expiry date 22-Nov-2022 which were affected. Vial was moved from freezer to refrigerator on 25-Jul-2022. Unpunctured vials were returned to refrigerator and punctured vials were discarded. during visual inspection before vaccination it was normal. Before this there was no prior temperature excursion.  No treatment medication was reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-627779 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2022: Live Follow Up -Significant Information include narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-627779:
This spontaneous report as received from currently 69 year old male patient, referring to himself. The patient's concurrent conditions included hypertension, cholesterol and thyroid. He experienced drug reactions/allergies to Metoprolol, simvastatin (manufacturer unknown), Lisinopril (manufacturer unknown), codeine, amlodipine, niacin, doxycycline, dicloxacillin, dapsone, penicillin and amoxicillin. On 15-APR-2015, the patient was vaccinated with ZOSTAVAX (dose, site of administration, lot # and expiry date were not reported), intravenously. Concomitant therapies included losartan potassium (manufacturer unknown) 100 mg, "OXYMINE" 100 mg, hydralazine 75 mg, spironolactone 50 mg and meloxicam (manufacturer unknown) 15 mg. Since 19-APR-2015, also reported as for the last year and a half, after having ZOSTAVAX administered, the patient experienced what appears to be chickenpox. He also noted that he was experiencing large, painful open sores and intermittent infections. There was no treatment given for the adverse events. The outcome of the events was unknown. The patient sought unspecified medical attention. The relatedness between the events and ZOSTAVAX was not provided. This is one of several reports regarding the same patient. Additional information has been requested.
Hand have be opening up completely since I got the vaccine. Bumps all over my arms and nipples. Anal itching. Back, butt, and thigh,neck itching
p/vax pt exp gen rash, malaise & fever;pt sought unspecified medical attention;
The shot caused a reaction to her medication; Feeling hot all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot all over the body) and ADVERSE REACTION (The shot caused a reaction to her medication) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DOXEPINE, FOSINOPRIL, AMLODIPINE, TIMOLOL and PREDNISOLONE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FEELING HOT (Feeling hot all over the body). On an unknown date, the patient experienced ADVERSE REACTION (The shot caused a reaction to her medication). At the time of the report, FEELING HOT (Feeling hot all over the body) and ADVERSE REACTION (The shot caused a reaction to her medication) outcome was unknown.            Treatment medication were not reported.  Follow up received on 02-Aug-2021. the patient did not have an email or fax, She asked if the forms could be mailed to her. She also stated that the shot caused a reaction to her medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant Follow up received on 02-Aug-2021. Event, "Shot caused reaction to her medication" was added. Updated contact details.
Wife called home health and said pt wasn't feeling well, was more drowsy than usual.  HH Aide visited at 9:15 AM.  He was afebrile and respirations were 36.  Skin was cold and clammy.  Aide encouraged daughter to take him to ER.  Daughter stated she thought he might get to feeling better and that if he didn't get better or if he seemed worse, she would take him.  RN talked to wife later in afternoon around 3:00 PM and wife reported he had eaten some and seemed to be feeling a little better.  When his wife went to wake him early Thursday AM , she could not arouse him and she called 911. When they responded the coroner was called.  12/3/09 Death Certificate received. DOD 11/26/09. Final Cause of Death: Myocardial Infarction, NOS & Chronic Pulmonary Disease, Dementia, Stroke (CVA).
administered on 06/01/2013; administered on 08/20/2004; This spontaneous report has been received from an other health professional, via a medical record from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS # 2303USA000299), concerning 26-month-old female patient.  Historical vaccines included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis B vaccine, hib vaccine, measles vaccine live (enders-edmonston) (+) mumps vaccine live (jeryl lynn) (+) rubella vaccine live (wistar ra 27/3) (M M R II), pneumococcal vaccine conj 13v (crm197) (13 VALENT PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE), and polio vaccine inact (IPV). Concurrent condition and medical history were not reported. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) tetanus vaccine toxoid (INFANRIX), hepatitis a vaccine, inactivated (manufacturer unknown), and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).  On 20-AUG-2004, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose, route, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age). On 01-JUN-2013, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection for prophylaxis (strength, dose, route, lot #, and expiry date were not provided) (Product administered to patient of inappropriate age).  This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2303USA000299: US-009507513-2306USA002994:
Pt received 2nd dose of Engerix had onset of diarrhea, fever, chills. Pt missed few days at work, no treatment given, condition resolving
Initial report received from a healthcare professional on 21 OCTOBER 2014.  A 59 year old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose  of FLUZONE QIV (batch number U5008BA and expiry date not reported) in the left deltoid on 21-OCT-2014. On 21-OCT-2014, two hours after vaccination, the patient called the pharmacy to report that she had red, itchy and swollen left deltoid.  Pharmacist advised her to take BENADRYL. The patient had no illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions were none reported. Corrective treatment was not reported and laboratory data were reported as none. At the time of this report the outcome of the adverse events was unknown. List of documents held by sender: none. Follow-up received from a healthcare professional on 27 JANUARY 2015 and 30 JANUARY 2015. It was reported that patient had received dose 1 of vaccine. No relevant laboratory or diagnostic tests were needed and no treatment information was available. The patient recovered after few days on an unspecified date.
The morning after receiving my Moderna booster shot, I woke up around 11am feeling slightly nauseous, with a headache and muscle aches, and I was very tired so I drank a large glass of water and went back to sleep until around 4pm. At this time I slowly ate some food and the nausea seemed to go away, then I took some Tylenol and drank a lot of water, and soon the headache and body aches started to be relieved. I also started to have a fever around this time, but it wasn?t anything too terrible. I laid down for the rest of the day and played some video games for a little bit. I got fever and chills for a bit, then I checked my temperature a little while later and it seemed to have gone back to normal for a little while. Around 11 pm I took some more Tylenol as the body aches had come back, and I had a fever again. When I woke up the following morning around 11am I was feeling significantly better and my fever seems to have broken. I still don?t feel completely better but I do feel significantly better and I don?t think I will need to be tested for covid.
The patient was administered the Pfizer COVID 19 vaccine in her left deltoid muscle at approximately 1:55pm. The patient was advised to remain in the store for 15 minutes and let me (PharmD) know if she had any issues. At 2:37pm she called the pharmacy and reported that she was red and itchy all over. I asked if she was still in the store and she said no, she had waited the 15 minutes but already left. I asked if she was having difficulty breathing and she said her "throat feels like it does with peanuts". She was advised to seek medical attention immediately at the closest urgent care or ER. She was also advised to take oral benadryl if she had any available. No further information is available at this time.
No adverse event occurred. The patient was 12 years old and was supposed to receive the Pfizer 12+ vaccine but received the Pfizer Peds (5-11yo) vaccine instead. On the return visit he received the correct vaccine Pfizer 12+ vaccine. Vaccination #2 Pfizer 12+ Lot #: FE 3594 Left arm.
Patient c/o bruising to left outer quadrant of her left breast began 24 hours after pfizer #3 injection.  She also developed pain along the lateral/inferior breast and day #9 began to have pain along the medial breast.  Exam showed a 2x3cm eccymosis (yellow) Left outer breast quadrant with mild tenderness surrounding the perimeter of the breast (lateral/medial/inferior).  No axillary lymph nodes or adenopathy.
PEDIATRIC DOSE GIVEN TO 19 YEAR OLD PATIENT.  PT AWARE W/IN 5 MINUTES OF INJECTION. INSTRUCTED TO HAVE REPEATED, PER GSK, ONCE ADULT DOSE ARRIVES IN OFFICE.
nausea, trouble swallowing, chest tightness, dizziness. Taken to ED. Given Benadryl 25 mg IV, Epi 0.3 mg subcutaneous, methylprednisolone 125 mg IV. Discharged home with steroids and Benadryl.
Several patients miss the 2nd dose due to COVID-19 pandemic; This non-serious case was reported by a other health professional via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Several patients miss the 2nd dose due to COVID-19 pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The pharmacy technician stated that at the time of reporting, the reporter did not had any of the patient/ dosing information available. The reporter did not want her personal information in database, but states it is fine to follow-up with a pharmacist if needed by fax, phone, or mail. The reporter consented to follow-up. The case was linked with case US2023AMR055920, reported by same reporter. The several patients missed the 2 to 6 months dosing window for the second dose due to Covid-19 pandemic, which led to social problem.; Sender's Comments:  US-GSK-US2023AMR055920:Same reporter.
my lips started to swell about 24hrs after the shot i took some Benadryl and the swelling went down
Swollen lymph nodes collarbone; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration on an unknown date (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced swollen lymph nodes collarbone. The clinical outcome of the event swollen lymph nodes collarbone was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.