chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; Redness left arm; Sore left arm; joint pain left hip; itchy in the back; sweats; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the first episode of FATIGUE (fatigue), the second episode of FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Redness left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (itchy in the back), HYPERHIDROSIS (sweats) and the first episode of FATIGUE (fatigue). On 12-Aug-2021, the patient experienced the second episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE PAIN (Sore left arm). 12-Aug-2021, the patient experienced ARTHRALGIA (joint pain left hip). At the time of the report, PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the last episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE PAIN (Sore left arm) and ARTHRALGIA (joint pain left hip) outcome was unknown.            No Concomitant medication was reported.  No treatment was reported.  Company Comment: 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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.   Reporter did not allow further contact; 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. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.
Information has been received from a pharmacist via a field employee concerning an approximately 53 years old female patient who on 18-JUL-2013 was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot# not reported) subcutaneously which was administered by the pharmacist. The patient called the pharmacy on 24-JUL-2013 to report that two hours after the injection on 18-JUL-2013, she developed painful headaches and felt fatigue for three days. The patient reported to the pharmacist that she brake out with painful blisters on one breast on an unknown date in July 2013, and had not yet sought treatment from a physician. No treatment has been given at this time. The pharmacist called unspecified physician to inform him of the adverse event. At the time of reporting, the outcome of events was unknown. Additional information has been requested.
Painful rash on neck with hives @ 2000. Took 2 Benadryl @ 2030.
TINNITUS IN  LEFT EAR ( MY SHOT ARM). STARTED AS A SOFT BUZZ. HAS WORSENED TO A VERY LOUD BUZZ. AS OF NOW NO TREATMENT AVAILABLE AS STATED BY HEALTH PROFESSIONAL.   I WOULD LIKE INFORMATION ON OTHER PEOPLE IF TINNITUS HAS LESSEN OR GONE AWAY. IT IS VERY VERY ANNOYING.
SLIGHT METALLIC TASTE IN MOUTH, BACKACHE AND CHILLS, STATED HE FELT LIKE HE WAS GETTING A UTI OR KIDNEY INFECTION.  DRANK 2 GLASSES OF CRANBERRY JUICE AND FELT BETTER THE NEXT DAY
Patient noticed local reaction of redness to the injection site after Anthrax series injection.  Patient presented after hours to clinic on Sunday morning, 5/16/2010 with the above complaint.  Reaction was treated as local reaction to bandage over the injection site with hydrocortisone cream with no relief.  Patient presented to clinic again on Monday, 5/17/2010.  Patient presented with 11 x 10cm redness area on left anterior bicep region (injection site) which was warm to touch and erythema marked.  Patient also complained of itching in the affected area.  No fever noted. Vital signs unremarkable.  Patient diagnosed with cellulitis and prescribed cephalexin 500mg twice daily for 10 days.  Patient notified to follow up if redness spreads.
Missed menstrual period; This is a spontaneous report from a non-contactable nurse, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Aug2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (also reported as none). Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 03Sep2021, it was reported that the patient missed menstrual period. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event missed menstrual period. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event missed menstrual period was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash began one day approx. 24 hours after receiving 2nd dose of Pfizer vaccine. Denied issues following 1st vaccine in series. Rash began evening of 04/09/21 and became increasingly worse Saturday 04/10/21. He initially believed rash to be a "yeast" rash from taking Farxiga describing rash began in groin region and RT inner thigh = Friday evening. Following day rash spread to LT shoulder, neck, abdomen, wrists bilaterally, anterior and posterior legs bilaterally. Rash described as mostly red dots and very itchy. Size of dots varied and were not oozing. Only place did not have rash was on his back, he stated. He notified PHN on 04/19/20 and he was encouraged to call his provider to discuss alternate diagnosis and/ or treatment options. He called his PCP and finally received a prescription which he started 04/21/2021. Prescribed: Famotidine 2x per day and Cetirizine 2x per day. No change in rash within a day, when asked.
This case was reported by a healthcare professional and described the occurrence of generalized rash in an adult male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject is a physician. On 05 October 2005 the subject received 1st dose of Fluarix. At an unspecified time following the administration of Fluarix, on 05 October 2005, the subject experienced a generalized rash. The generalized rash resolved on an unspecified date on or after 05 October 2005 and on or before 07 October 2005.
Muscles of entire body started to be painful.  Ran temperature of >100 for apprx 36 hrs.  Profound weakness for apprx 10 days afterward.  Continued to have muscle pains/cramping for years thereafter.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 11-MAY-2018, the patient was vaccinated with Oka/Merck VARIVAX intramuscularly (lot #, expiration date, dose and strength were not provided) for prophylaxis. Other suspect therapies included sterile diluent intramuscularly (lot #, expiration date and dose were not provided) for prophylaxis. The patients did not experienced any adverse events.
Developed pain in right calf and hamstring.  No improvement over the next few days.  Went to Vein specialist and they performed an ultrasound.  A blood clot was found in my right calf.
Original vaccine administration site no longer had Moderna available for patient's second dose; Missed dose; A spontaneous report was received from a consumer, concerning her husband, a male patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and original vaccine administration site no longer had Moderna available for patient's second dose/ product availability issue and missed dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, patient's original vaccine administration site no longer had Moderna available for patient's second dose and several other clinics had also refused the vaccine to patient as patient did not obtain his first dose at their facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events original vaccine administration site no longer had Moderna available for patient's second dose and missed dose were considered unknown at the time of this report.; Reporter's Comments: This report refers to a male patient of unspecified age who experienced non-serious unexpected event of original vaccine administration site no longer had Moderna available for patient's second dose/ (product availability issue and missed dose). There were no reported AEs associated with this case of product availability issue and missed dose.
Red small itchy area on rt forearm after her vaccine. The reddened area was itchy but not spreading. Pt placed an ice pack over the area and the reddened area went away. Pt felt better after 15 min the she signed a release to the observation area and checked herself out.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender unknown. Pertinent medical history, drug reactions or allergies were not reported. The pharmacist reported that an expired Merck sterile diluent (Lot number: G000184, expire date: 31-MAR-2012) was reconstituted with ZOSTAVAX (Lot number: J001004, expire date; 24-APR-2014) and given to a patient on 23-SEP-2013. Concentration, duration, route of administration and indication were not reported. No adverse events were reported. Concomitant medications were not reported. Additional information has been requested.
- Pt stop breathing - Non-response to stimulation - Cold - Color became blue - High heart rate - Swelling of neck, face.
Fever, chills, sweating, increased blood pressure, increase pulse rate, rash on right arm
About 3 days after vaccine shot began getting raised,red,itchy patches on legs,arms and elbows. As of today these symptoms have been going on for 3 weeks.
Fever, Chills, Aches, Pains, Headache, Nausea
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # (671022/0745AA, expiry date:18-AUG-2012) that had expired on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Approximately 5 hours following the 2nd dose, I began to experience total body aches. Pain became acute from head to toe, with onset of chills with fever (6 degrees above normal), racing heart, congestion, migraine from aching jaw, delirious all night. Ringing in my ears and nausea. I was very well hydrated before/after vaccine. By morning, BP was back down to 113/61, but I could still hear/feel my heartbeat in my throat. Most symptoms resolved after 24 hours, other than temperature and jaw ache.
extreme fatigue, shortness of breath, sleepiness, headache , chest tightness and brochoconstriction
Itchy Rash, swelling, redness at injection site. Began as soon as I awoke on 8/17. Larger in size and shape and redness on 8/18.
Similar issues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Similar issues) 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 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Similar issues). At the time of the report, VACCINATION COMPLICATION (Similar issues) outcome was unknown.            No concomitant medication provided. No treatment medications provided.
his is a 92-year-old male with a past medical history significant for coronary artery disease, DVT, GERD, subdural hemorrhage and craniotomy and cholecystectomy, who presents to the emergency department with complaints of progressive symptoms of cough, shortness of breath and altered mentation for approximately 1-1/2 days.  This occurs in the setting of a recent fall.  Patient was seen in the emergency department on 4/22/2022 for fall when he tripped while using his walker.  The patient suffered a comminuted impacted fracture of the neck of the right humerus.  Patient's radiographic studies in the emergency department on that day were x-rays of the shoulder as well as CT scans of the shoulder.  He did not have any other scans of the head neck as he had denied any head injury no loss of consciousness.  Patient has presently a nonproductive cough shortness of breath and increased dyspnea on exertion and per the son is more confused
Febrile seizure 4-11-2020 ER visit 103 fever Labs - normal Treated in ER for otitis media rt ear
Patient had a difficult time swallowing his food.  He said that "his throat was closing up".  His allergic reaction to the shot lasted for 7 days. When he was seen by the doctor, they checked him for Strep Throat.  They could not find anything wrong with him.  They were aware that he just got his H1N1 shot and told us to wait it out a couple of days.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 111 patient of the total 190 patients. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Petite mall seizures lasting half a day. (has had this type of seizure before, but has been years since the last once) memory loss.
No symptoms after dose #1 only after dose #2 came down with Covid and had Covid Rash  starting about July 28th or 29th 2021.
devel stomachache approx 30mins p/vax;home p/vax;lunch slumped over in chair;temp of 102 given APAP elixir;has been sleeping most of time for past 20hrs;tried to eat milk&toast 11OCT evening&vomited;12OCT AM,tired food&fluids,vomit
Hot cheeks; General lack of energy; problems sleeping, waking up every hour until dawn; uncomfortably hot no fever detected; Tiredness; fatigue; Sore injection arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore injection arm), FEELING HOT (Hot cheeks), ASTHENIA (General lack of energy), INSOMNIA (problems sleeping, waking up every hour until dawn) and FEELING HOT (uncomfortably hot no fever detected) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore injection arm). On 10-Feb-2021, the patient experienced FEELING HOT (Hot cheeks), ASTHENIA (General lack of energy), INSOMNIA (problems sleeping, waking up every hour until dawn), FEELING HOT (uncomfortably hot no fever detected), FATIGUE (Tiredness) and FATIGUE (fatigue). On 16-Mar-2021, PAIN IN EXTREMITY (Sore injection arm) and FEELING HOT (Hot cheeks) had resolved. At the time of the report, ASTHENIA (General lack of energy), INSOMNIA (problems sleeping, waking up every hour until dawn), FEELING HOT (uncomfortably hot no fever detected), FATIGUE (Tiredness) and FATIGUE (fatigue) outcome was unknown. Not Provided          Concomitant medications were not provided.
Headache 3 days tightness in upper chest from shoulder to shoulder for 3 days
Mild redness and swelling on (L) arm; erythema about 4x2cm in size where vaccinated
rash scattered red sl raised covers entire body; no evidence of itching; no fever no evidence of any distress;
I started my period and it was very very heavy/After 2sec booster 15Nov2022 I started my period 07Dec and again it's very very heavy; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 03:45 as dose 4 (booster), single (Lot number: GH9697) at the age of 46 years, in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: I was covid +. Concomitant medication(s) included: CETIRIZINE; ATORVASTATIN. Vaccination history included: moderna (DOSE 3 (BOOSTER), SINGLE; Lot number: 027H21B, Vaccine location: Left arm), administration date: 30Dec2021, when the patient was 45-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EJ1685, Vaccine location: Left arm), administration date: 21Jan2021, when the patient was 44-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1 SINGLE; Lot number: EJ1685, Vaccine location: Left arm), administration date: 31Dec2020, for Covid-19 immunization, reaction(s): "Menstrual flow excessive". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 07Dec2022, outcome "not recovered", described as "I started my period and it was very very heavy/After 2sec booster 15Nov2022 I started my period 07Dec and again it's very very heavy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient got vaccine dose 1 of primary series while she was covid positive without knowing. Few days later, she started her period and it was very heavy. Next period was heavy but not as much then it went back to normal. After second booster on 15Nov2022, she started her period on 07Dec and again it was very heavy. She never had her periods be this heavy in her life. Changing super abs tampons every 30mins same as in Dec2020. She had read case reports of heavy menstrual cycles post COVID infections and from vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
anaphylactic reaction/anaphylactic shock; The vial has a warning in very tiny print. Why is it not clearly marked on the package; Initial information was received on 15-Jul-2021 regarding an unsolicited valid serious case from a other health professional (Inquiry number: 00684271)..  This case involves a 22-year-old female patient who experienced anaphylactic reaction/anaphylactic shock (anaphylactic reaction) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical treatment, vaccination, concomitant medication and family history were not provided.  At the time of the event, the patient had ongoing Latex allergy.  On 12-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6737AA, expiry date: 09-Jul-2022] via an intramuscular route at right deltoid for prophylactic vaccination.  On 12-Jul-2021 the patient developed a serious anaphylactic reaction/anaphylactic shock (anaphylactic reaction) and was transported by ambulance to the ER for treatment on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant.  It was reported that they were not aware at the time that the tip was latex and the patient had a severe latex allergy and also the vial had a warning in very tiny print (Product use complaint).   Reporter states that the incident could have been avoided if the latex content was clearly noted. Reporter also says on other manufacturers boxes, it boldly states the latex content, the patient is a college student who came in to satisfy requirements and she ended up in the hospital. She has no way of paying the hospital and ambulance bill.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the patient was recovered from the event anaphylactic reaction.; Sender's Comments: This case involves a 22-year-old female patient who experienced anaphylactic reaction on the same day after vaccination with ADACEL. The ADACEL vial had a warning in very tiny print (Product use complaint). The time to onset was compatible. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Chills started at 20:00 and continued all night.  Arm sore for 2 days at site of vaccination.  4 days after felt wheezy and had mild cough that is still going on.  4 days after vaccination, rash on opposite site of left forearm and on right arm also had bumps that lasted 1 night.