chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very bad chills; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (very bad chills) and COUGH (dry cough) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (very bad chills) and COUGH (dry cough). At the time of the report, CHILLS (very bad chills) and COUGH (dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (very bad chills) and COUGH (dry cough) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (very bad chills) and COUGH (dry cough). At the time of the report, CHILLS (very bad chills) and COUGH (dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
No adverse event reported; Gardasil 9 had been stored in the freezer rathen than the refrigerator. It was administered one time this morning; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's, pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 11-JAN-2021 (also reported as: this morning), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (route of administration, anatomical location and vaccine scheme were not provided), lot number: R036913 has been verified to be a valid lot number, expiration date was on 23-SEP-2021 as prophylaxis. On the same date (reported as "when we came in today"), it was realized that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) had been stored in the freezer rather than the refrigerator (product storage error ) and it was administered one time this morning. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -11 Fahrenheit (°F), for a time frame of 24 hours 0 minutes. A digital data logger was involved. There were no previous temperature excursions reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp and Dohme Corp.; devicelotnumber: R036913; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Initial report received from a consumer on 28 August 2012. A 4-month-old male patient, whose medical history and concomitant medications were reported as none, received intramuscular dose of PENTACEL vaccine in left thigh (lot number: C4127AA) on 07 June 2012. The reporter stated that on the day of vaccination i.e. 07 June 2012 child's thigh was swollen and covered in a raised rash, but not itchy. The boarder of the rash was a darker red than the rest of the rash. The Patient's history of adverse event to previous vaccination and corrective treatments were not reported. Laboratory details were none. The outcome of the event was recovered on unspecified date. List of documents held by sender: none. Follow up information received on 31 October 2012. The patient had no illness at the time of vaccination and had no vaccinations within 4 weeks of 07 June 2012. The patient had received 1 dose of DAPTACEL vaccine on an unspecified date. The patient (birth weight reported as 6 lb and 3 oz) received an intramuscular dose 2 of DAPTACEL (batch number: C4127AA) on left thigh on 07 June 2012 (previously reported as PENTACEL). The patient was referred to an allergist.
fever; Chills; body aches/aches and pains; not been feeling well; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported for a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient previously took Zpack for cough.  The patient experienced fever, chills, body aches, aches and pains, not been feeling well in Jan2021. The patient received steroid for the events. The outcome of events was unknown.    Information about Batch/Lot number has been requested.
Pt recvd 3 doses of Engerix-B 8NOV90, 10DEC90 & 17JUN91 & 24JUL91 tested for Anti-HBS & found to be non-reactive; 29JUL91 recvd 4th dose of Engerix-B; Tested 11SEP91 for Anti-HBS & found to be reactive;
Patient reported pain and swelling in arm since injection, was seen by physician 2/4/19, he determined it was an allergic reaction to shot and gave Prednisone 20mg on 2/4/19.
I have had four (4) flu shots over the last 35 plus years with three (3) different doctors. Dr who retired Sept. 1994, from family practice was my doctor for 30 years. He passed away recently. He gave me my first two shots, both times I came down almost immediately with the flu. These shots were given years apart because when I came down with the flu the first time, I was hesitant to get another shot. He said it was just a coincidence until I got the flu again. Another Dr moved into his offices. He was my doctor from Sept. 1994 to March 2000, he gave a shot between those years and again I got the flu. Yet another Dr has been my doctor since Jan. 2014. I had no medical coverage between the two. He gave me the flu shot Sept. 16, 2015. He was told about the first three (3) shots. This was the first time I have received an information sheet. I did have flu symptoms, but not full blown flu. I also got a severe rash/infection at my surgical site for my left hip replacement scar. This procedure was performed July 2014, also sustained severe swelling and hardness of my testicles similar to that of a regulation size soft ball and a rash on my buttocks. I do have a small case of herpes that doesn't affect my testicles or my entire buttock region. I had to take two antibiotics for three weeks to clear these conditions. As it stands now, I know I cannot or will not take any flu shots in the future. Apparently, I am one of a few people who should not receive these shots.
Chicken pox like rash that took MONTHS to go away. It was NOT mild, covered most of my body.
Pt received PCV13 (L) thigh and FLUZONE (L) thigh on 10-15-10. Mom stated in distant past developed cellulitis to a vaccine, she now believes was PCV7. Pt c/o pain (L) thigh, some firmness to (L) thigh, no redness, min. warmth.
Patient experienced a numb arm. Patient's numbness continued to improve as she was monitored and has not returned our calls for follow up from initial encounter.
This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 31-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EP6955, expiry date: not reported), at the vaccination age of 31, via an unspecified route of administration, on Mar 29, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On Mar 30, 2021 (on the arm she received the vaccine), patient experienced muscle soreness on armpit and felt a nodule inflammation in her armpit, with outcome of unknown. No follow-up attempts possible. No further information expected.
Itching and rash at injection site.  Given IV Benadryl, solumedrol, Pepcid.  Rash resolved after treatment.
Uncomfortable; Headache; body aches; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Uncomfortable), HEADACHE (Headache), MYALGIA (body aches) and VACCINATION SITE PAIN (pain at the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced DISCOMFORT (Uncomfortable), HEADACHE (Headache), MYALGIA (body aches) and VACCINATION SITE PAIN (pain at the injection site). On 09-Feb-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, DISCOMFORT (Uncomfortable), MYALGIA (body aches) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol
This spontaneous report as received from a pharmacist refers to a female patient of unknown age without drug reactions or allergies. The patient has medical history of shingles. The patient was vaccinated with ZOSTAVAX (lot number, dose and injection site were not reported) intramuscular on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-OCT-2012 the patient received ZOSTAVAX via intramuscular route and felt little sore at the injection site. There was no treatment given for adverse events and no laboratory diagnostics study performed. The patient was not recovered at the time of report. The patient had seen the pharmacist for medical attention. Additional information has been requested.
Armpit, on the site of the injection, after two days, it start to swell; Armpit is swelling; Armpit is swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, Single), for Covid-19 immunization; Bnt162b2 (Dose2, Single), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Armpit, on the site of the injection, after two days, it start to swell; Armpit is swelling"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Armpit is swelling".  Additional Information: Consumer stated, "I have a concern about the Covid-19, the booster shot. I just have a question about the side effect because I took the booster shot on Monday and my armpit, on the site of the injection, after two days, it starts to swell. So, the armpit is swelling and 'just little bit of that swelling'. So, the patient just wanted to know are these adverse events are normal or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He received a Tdap IZ in mid-January 2012 at Hospital ER. He had a laceration that needed stitches. A few hours after receiving the vaccine he developed a fever and had flu-like symptoms that lasted 2 1/2 day. He also had site soreness (IZ was given in the thigh) for one week. Could not manage stairs for 2 days.
After receiving vaccines listed, pt c/o CP/SOB. Pt appeared in NAD. Breathing even & unlabored. Pulse 76 & regular. BP 142/88, interpreter used to help assess pt. Pain a 5 (scale 1-10). Reports he had CT 2 days prior with exercise & hx of CP. Assessed by nurse practitioner. O2 given via nasal canula. Transported to ER via rescue squad.
Lymphangitis. Left arm with erythema extending from vaccine site to axilla; tender axillary nodes.
This spontaneous report was received from a licensed practical nurse and refers to a 5 year old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on an unspecified date, the patient was vaccinated with GARDASIL 9 (strength, dosage, frequency, route, lot # and expiration date were not provided), for prophylaxis, instead of PENTACEL. No adverse symptoms were reported.
dementia flared up; Friend got worse / dementia flared up; Feel lousy; Starting to forget more and more after the shot/friend got worse and is starting to not remember things; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia flared up) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia flared up) (seriousness criterion medically significant), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things). At the time of the report, DEMENTIA (dementia flared up), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was provided.  No Treatment drug information was provided.  Company Comment An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 wherein events were added and case was upgraded to serious.; Sender's Comments: An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: They both got their COVID vaccine first shots 2 weeks ago. He had nothing but a sore arm. His wasn't sore past a day. number and expiry date were not reported. The report is cross referenced to report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 10-year-old male who in approximately November 2007 (within the last month), was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 659204/1470U). In approximately November 2007 (within the last month), the patient experienced injection site redness, fever, and crusting around the injection site area. The patient was taken to the emergency room twice. The office suspected the diluent and disposed of all diluent of that lot number (lot number unavailable). On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Red, hot left shoulder, numb in left temporal region of face, posterior aspect of left back sore, thoracic level. Fever.
pt recv vax & 5-8min post vax pt fell to the ground in a faint & appeared pale & clammy;pt voided spontaneously;faint lasted approx 30sec;tx w/02 & observed for 1hr;
Patient with mild hives on hands bilaterally with 1st vaccine.  2nd vaccine (listed above), started with blister like rash starting on hands/arm, spreading to back and then trunk.  Rash eventually all over upper part of body, but not legs.
12/19/21  states she is to started getting sick last night.  Felt tired achy chills.  Today feverish scratchy sore throat rhinorrhea dry cough.  He got nauseated and vomited one time last night but not today.  No diarrhea.  Quite a bit of myalgia.  No known ill contacts.  She has been immunized against coronavirus and that she did have it last fall 2020.  No known ill contacts.  Not take anything for present symptoms.  No altered sense of smell nor taste. Review of Systems  Constitutional: Positive for chills, fatigue and fever.  HENT: Positive for rhinorrhea and sore throat (Mild scratchy).   Respiratory: Positive for cough. Negative for shortness of breath and wheezing.  12/19/21   Gastrointestinal: Positive for nausea and vomiting. Negative for diarrhea.  Musculoskeletal: Positive for myalgias.  Neurological: Positive for headaches (Mild).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 09:00 as dose 4 (booster), single (Lot number: CH9694) at the age of 79 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "dilated ascending aorta" (unspecified if ongoing); "BHP" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Covid symptoms included nasal and throat congestion, cough, sore throat, and fatigue. Therapeutic measures were taken as a result of vaccination failure, covid-19.
hives to different parts of her body that include, the neck and back.; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of an unspecified age received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) 2nd dose, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunization. The patient historical vaccine included BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives to different parts of her body that include, the neck and back on an unspecified date in 2021. Patient being followed up by a HCP and treated with antihistamines cream for relief. patient wanted to know the duration of this side effect. There might be many factors to considered including patient medical history and medical condition. Patient was recommended to consult healthcare provider about what she experienced. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I experience heart pounding palpitations that woke me from my sleep with elevated pressure.  Heart rate was 135 at rest at home and BP was 167/101.  I immediately went to the ER, where they did a work up and indicated I was having tachycardia but in sinus rhythm.  I am still having the problem and feeling unwell.  This started one week post vaccination.  I also had typical muscle aches, chills and headache 12 following the vaccine.   Those symptoms  have continued.
brief episode of tonic jerking of arms w/blank stare up to 30sec followed by drowsiness & forgetting to breath then turned pink;similar episodes occurred intermittently x 2 1/2hr;
11-24-09 Dad reported son had runny nose, dry eyes, swelling, eyes closed shut at 6pm. 11/23/09 kept home from school today. He also had wheezing, SOB, sneezing. He used an albuterol sulfate/prostroperium bromide inhaler 1 puff & gave him BENADRYL eyes shut until 11pm-open partially 10-20% now.
Resting heart rate increased from 60 bpm to 120 bpm for 3 days after injection.  Other symptoms included fatigue and body aches.   Resting heart rate returned to normal, but remained reactive with palpitations for approximately 6 weeks following along with the fatigue.
pt recv vax OCT96 & devel a h/a;this is one of five cases reported by RN;cross reference to 0010150960105 & 0010150960144 to 0010150960147;
Pt claims that reaction started almost immediately as pain, soreness at injection site; malaise;  Pt still have what he described as pain in shoulder, clavicle and joints on left side; pt stated range of motion is not limited, no restrictions.
ON 12/31/2020 I  HAVE A HAD SLIGHT FEVER, HEADACHE , NAUSEA, BODY ACHES, CHILLS, HAND TREMORS,  DIZZY AND LIGHTHEADED  THAT LASTED FOR 3 DAYS.  SINCE THEN I HAVE  A BAD HEADACHE, FEELING NAUSEA AND  VERY LIGHT HEADED AT TIMES.
The next morning 1/28/2021, I got up to try to get my daughter ready for school at 8:30AM and could barely walk.  I felt like I was hit by a truck.  Fever, dizziness, chills, headache, nausea and loss of appetite.  I stayed in bed until 5pm without getting up not once to go to the bathroom.  At 5pm, I felt normal again and that evening I was feeling 100% better.
Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7.; This non-serious spontaneous safety report was received on 25-NOV-2022 from a physician.   The case is a follow up case number 02272790/ Interaction# 02272763 (MCM-004233)  It was reported that the patient did not experience any adverse event (Temperature excursion only).  Due to the nature of the event, the causality between the event "Vaccines administered after temperature excursion (46.2 F). Vaccines involved: VAXELIS U7205AA and VAXELIS U7151AA 7" and Vaxelis was not applicable.  For reference purposes, the case is linked to MCM-004233, MCM-004326 and MCM-004325.  Further information is expected.
Redness, swelling and itching. Diphenhydramine 50 mg once.