chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my booster dose I had diarrhea/It took me 3 days after I received the booster dose before felt fine; I received my booster dose the skin on the inside of my lips  and mouth felt loose/It took me 3 days after I received the booster dose before felt fine; I received my booster dose I had fever/It took me 3 days after I received the booster dose before felt fine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I received my booster dose I had diarrhea/It took me 3 days after I received the booster dose before felt fine), MOUTH SWELLING (I received my booster dose the skin on the inside of my lips  and mouth felt loose/It took me 3 days after I received the booster dose before felt fine) and PYREXIA (I received my booster dose I had fever/It took me 3 days after I received the booster dose before felt fine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B311421A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced DIARRHOEA (I received my booster dose I had diarrhea/It took me 3 days after I received the booster dose before felt fine), MOUTH SWELLING (I received my booster dose the skin on the inside of my lips  and mouth felt loose/It took me 3 days after I received the booster dose before felt fine) and PYREXIA (I received my booster dose I had fever/It took me 3 days after I received the booster dose before felt fine). On 26-Nov-2021, DIARRHOEA (I received my booster dose I had diarrhea/It took me 3 days after I received the booster dose before felt fine), MOUTH SWELLING (I received my booster dose the skin on the inside of my lips  and mouth felt loose/It took me 3 days after I received the booster dose before felt fine) and PYREXIA (I received my booster dose I had fever/It took me 3 days after I received the booster dose before felt fine) had resolved.            Concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-405905 (Patient Link).
First 3 days=sore right arm. 7 days after vaccine (symptoms for 8 days)=sore throat, dizziness, lethargy.
First shot - no symptoms  Second shot- numb and tingling on the left side of my face, left hand fingertips where numb as well. Next day at 3:30a chillis and sweats no fever   Left side of my face was numb and tingling, left finger tips where numb as well, left arm felt like body builder arm couldn?t lift. Woke up at 3:30a next day w chills and body ache. No fever
Initial swelling and pain, which has gradually decreased, but still significant.. Denies loss of sensation, change in color or temperature. No swelling of extremity. Some improvement with Tylenol, heat, and muscle relaxers.
Red, swollen at site of injection. Red spot approximately 1 centimeter diameter with scab at center. Patient squeezed pus from injection site the day prior to today. No pain, no fever and not feeling sick.
Mild itching in right upper arm began on day 6. Noticed red area about 5 x 10 cm. Covid Arm Still present at day 13, sightly less red and inflamed.
PATIENT FELT DIZZY. I KEPT HER AWAKE.  SHE FELT A LITTLE NAUSEATED ALSO. CALLED 911 TWICE. BY THE TIME 911 PEOPLE SHOULD UP 20 MINUTES LATER, PATIENT WAS DOING FINE AND WALKED OUT WITH THE 911 PERSONNEL.
little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). At the time of the report, PAIN IN EXTREMITY (little sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided No treatment information provided. Patient took  the second dose and has no reaction to it.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated action taken, updated event outcome from unknown to recovered/resolved and added 2nd dose details.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE 6/25/2022 &  7/3/2022  --  RECURRENCE OF SAME SYMPTOMS
That night, no chills or fever but uncontrollable shaking -10 pm -4 am in morning. Starting at 10, as well, body aches -run over by a truck type. My chest was burning like it was on fire -lungs felt like they were on fire. I woke up the next morning, with a little bit of body aches -I slept the entire next day pretty much (the 7th). On the 7th, I noticed that my heart was beating - fluttering- skipping- beating. My left left also swelled up and was red. I had PVCs with pulmonary embolism on that left leg in 1996 -when I was doing the chemo. My left leg ached, burned and got red on the 7th. I was going to see the PCP the following week and I was still having issues with the heart but the leg was getting better. It can still swell, burn and get red quite a bit at night because I stand on my legs all day - but the amount of pain and swelling did go down over that week while I was waiting to see the doctor. I had an ultrasound on my leg. And a heart halter to monitor my heart for 24 hours. I do have PVCs. Stress from vaccine caused Herpes Outbreak - that was on the left inner thigh right next to genitals - bumps within four days of vaccine. Created more pain. Took Benadryl for pain - helps with the nerve pain - two days with. I took 3000 mg a day of Tylenol for three days after the vaccine. Have not recovered from the calf and heart symptoms.
getting Covid; getting Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 12 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Oct2021 (Lot number: 30155BA, Expiration Date: 31Mar2022) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting Covid".
my vaccination site is warm; vaccination site is red; vaccination site is kind of swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen). At the time of the report, VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported. Treatment information was not provided.
12 hours after her second COVID-19 vaccine, the patient experience shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hr after shortness of breath which she treated with benadryl. She was asymptomatic by the morning and has continued to be stable since event.
Fever (up to about 101) and feeling really feverish starting about 30 hours after my second Pfizer show. Lasted for about 5 hours.  No other issues and still thankful I got the vaccine.
No additional AE information provided.; ROTATEQ was administered to a patient after temperature excursions.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  lot #W002561, expiration date: 07-OCT-2023, taken orally (strength and dosage regimen were not provided) as prophylaxis (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 9.13 degrees Celsius (C) for 1 hour, and at minimum of -8.45 degrees Celsius (C) for 37 hours and 15 minutes, without previous excursions. No adverse events were reported.
Body wide rash with redness of the skin and petechiae on the lower extremities.  Additionally, feeling flushed and fatigued.
Pt recently dx w/ Hep C and providee wanted pt to receive Hep B & Hep A vaccines. Provider & clinic at time vaccine avail in clinic where pediatric vaccines were used. Pt directed to health dept for adult vaccines.
Rec'd ProQuad - MMR-V 4/23/07 (MMRV reaction) rash and fever Maculopapular rash on neck and back, cranky but consolable. Also had fever and diarrhea. Information has been received from a licensed graduate practical nurse concerning a 15-month-old male who on 23-APR-2007 was vaccinated with a first dose of PROQUAD. On 02-MAY-2007 the patient vomited once. This patient was seen in the office on 02-May-2007 with a maculopapular rash on his neck and back, he was cranky but consolable, and had a fever and diarrhea that lasted fo r3 days. The reporter felt that diarrhea, fever, cracky, maculopapular rash on neck and back and vomited were related to therapy with PROQUAD. On an unspecified date the patient recovered. This is one of several reports from the same reporter.
Pt presented with a fall, generalized weakness, neck pain, and scalp laceration. Pt had fever and chills during hospitalization and was found to be COVID positive. Chest x-ray was negative.
Fluarix administered to a 1-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 53Y2G, expiry date 30th June 2023) for prophylaxis.   In November 2022, the patient received Fluarix Quadrivalent 2022-2023 season. In November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 18-Nov-2022 Reporter's comment: During this call, the reporter did not had the opportunity to ask the health care professional, if follow up was ok to be included. Additional supportive information: The patient received Fluarix at inappropriate age, which led to inappropriate age at vaccine administration. Suspect was coded as solution for injection as no formulation was reported in source document.
On second day after receiving vaccine a canker-like sore inside of lip first appeared as bleeding while eating apple.  Appears as small blister-like lesion, red spot in center. No pain. Sore appears to be going away after 2 days, though still present. No further bleeding. No history of canker sores or other lesions inside of mouth or on lips.
Noticed redness/soreness/ had hard lump(very slight) at injection site next afternoon of injected flu vaccine (11/18/02). Used cold packs every couple of hours for next day during waking time period (8:30am-11pm) Swelling gone next day 11/20/02 and redness completely gone by 11/22/02 but still complains of mild pain, but getting progressively better. Temperature was 96.7 and steady at this rate for 24-36 hours.
Tdap & MENACTRA : post administration (seen at 2d) erythema, induration, itching 13 x 8 cm to left arm.
This case was reported by a consumer and described the occurrence of adverse event in a patient who received HAVRIX (batch number D23LP, expiry date 28th APRIL 2016). On 29th JUNE 2015, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to HAVRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. On 29th or 30th JUNE 2015, the patient was vaccinated with HAVRIX. After vaccination with HAVRIX the patient experienced an unspecified adverse event. No further details were provided.
The patient received the Janssen vaccine (rx number: 1473565) on 3/7/2021. On his immunization card, it is reported that he received dose #1 of the Pfizer vaccine that day. Per his immunization card, patient was given another Pfizer shot on 3/29/2021 2:00 PM to complete the series. Later that day around 5:00PM, it came to realization that our records show he received Janssen, which would not have required him to get Pfizer. His wife was contacted and claims he wanted the Janssen shot on 3/7/2021 but actually received Pfizer. The possibility may be that the wrong vaccination was entered in the system on 3/7/2021. Nonetheless, patient's wife claims no harm occurred from both vaccinations.
Administered vx reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA701A, expiry date February 2023) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Menveo. On 18th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The health care professional reported that menveo was reconstituted with sterile water and administered to a patient. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines reconstituted with sterile water which led to wrong solution used in drug reconstitution.
Tiredness; headache; muscle pain; chills; joint pain; fever; decreased appetite; received dose 3 on on 25Oct2021; This is a spontaneous report from a contactable consumer (patient) for herself via Regulatory Authority. A 79-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FE 3592), via an unspecified route of administration, administered in left arm on 25Oct2021 08:30(at age of 79-year-old) as dose 3 (BOOSTER), single for covid-19 immunization in hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included hyperparathyroid, Polycystic Ovary syndrome. The known allergies were nitrofurantoin (MACROBID) and dextropropoxyphene hydrochloride (DARVON). The other vaccine in four weeks included influenza vaccine(INFLUENZA, Batch/Lot Number: unknown) administered in right arm as dose 1, single for influenza immunization on 20Oct2021. The other concomitant medications in two weeks included Spironolactone 50 mg, Vitamins Multi, D3, glucosamine sulfate(GLUCOSAM). On 27Feb2021 08:15 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN 6203), via an unspecified route of administration, administered in left arm as dose 2, single for covid-19 immunization. On 04Feb2021 08:30 AM(at age of 78-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EM 9809), via an unspecified route of administration, administered in left arm as dose 1, single for covid-19 immunization. The patient experienced Tiredness, headache, muscle pain, chills, joint pain, fever, decreased appetite , all on 25Oct2021 21:00. The event was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature with result fever on 25Oct2021. No treatment was taken for the event. The outcome of event was recovering. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
RN dropped the syringe containing the vaccine on the floor, picked it up, and proceeded to administer in my left arm.  After the event, I learned that the Moderna vaccine is very fragile and should not be shaken.   I need guidance on what the next steps are.  Should I get a replacement first dose?  Is dropping the syringe considered as shaking the vial?  Time is of the essence, and would appreciate a quick response.  Thank you.
I did not have an adverse reaction to the vaccine. I am a nurse and have high exposure to COVID-19. I began feeling symptoms and tested positive for COVID-19 in 08/2022. I got a prescription for Paxlovid. My chef complaint is the awful metallic taste. I did have a rebound and tested positive again on 08/14/2022. As of today, I do not have any lingering symptoms.
within 15 minutes of receiving my injection, I experienced a strong metallic taste in my mouth that lasted constantly for a week after my injection. I am still occasionally experiencing an intermittent metallic taste, that dissipates quickly,. I am scheduled for my second injection this evening.
He c/o local reaction to 12/10/13 flu shot, (L) deltoid - 12/12/13. Today 12/17/13 it has improved and he said he can see a bruise over the site. He states he has had joint pain since 12/13/2013 that has been less pronounced today. He c/o migraine headaches the past 2 afternoons. He is taking TYLENOL - Ibuprofen for his aches and pains and headache. 12/18/13 call from pt symptoms have resolved.
Immediately after injection, a large knot formed about the size of a dime raised about 1/4 inch. No redness and patient says it does not hurt -- Referred patient to his primary Dr. after vaccination, patient reported being on Aspirin & PLAVIX.
She has had a red, sore arm since she got the vaccine. She went to visit her Dr, who determined that it was not infected, and that it was in the muscle.
Client admitted to feeling nervous at start of the appointment. She stated feeling dizzy after 3rd/last immunization was administered; was also seeing spots. She appeared pale and her hands were cold and clammy. The mother and myself lowered client to the floor, while another nurse brought in/turned on a fan, and brought a juice box for client to sip. After drinking the juice and reclining for 10 minutes, client felt well enough to walk (with assistance) to waiting room. She no longer appeared pale, and hands were no longer clammy. She then sat with mother for approximately 10 more minutes in the waiting room until they left the building.
Pt recvd DTP/OPV & w/in a few hrs of vax devel hives over entire body;
Significant exacerbation of wheezing. Pt had 2nd HPV 6/12/07 - Merck 0587V. Similar symptoms.
I had a fever of average 101.5 throughout the night and into the following morning. I also had one episode of vomiting at 11:40 pm on the same day I received the vaccine.
Case number PHEH2014US023596, is an initial spontaneous report from a consumer (also patient) received on 24 Nov 2014. This report refers to a 69-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 146305) intramuscularly 09 Oct 2014. On 12 Oct 2014, a few days after vaccination, the patient experienced myalgia and elevated temperature. The outcome of the event myalgia was not resolved and outcome of elevated temperature was unknown. Seriousness and causality was not reported.
Shingles one week after shot; This is a spontaneous report received from a Contactable Consumer. A 59-Year-old male (Adult 18-64 Years) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in left arm, on 19Feb2021 at 18:45 (at the age of 59 years), as a single dose for COVID-19 immunisation. The patient medical history included Hypertension, herpes. Concomitant medications was not reported. The patient had no known allergies. Prior vaccination, the patient had no covid. Post vaccination, the patient had not tested for covid. The patient didn't receive other vaccine in four weeks. The patient received other medications in two weeks. On 24Feb2021, the patient had experienced Shingles one week after shot. Not sure if related but thought should report. AE resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the AE. Outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. .
This case was reported by a physician via call center representative and described the occurrence of shivering in a 66-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received 6 to 8 weeks before the time of reporting, refer case US2018GSK216201). On 14th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 14th November 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short. In November 2018, the patient experienced shivering, back pain and fever. On an unknown date, the outcome of the shivering, back pain, fever and drug dose administration interval too short were unknown. It was unknown if the reporter considered the shivering, back pain and fever to be related to SHINGRIX. Additional details were reported as follow: The patient was a physician. The patient received 2nd dose of SHINGRIX 6 to 8 weeks after the 1st dose of SHINGRIX, which might led to possible shortening of the vaccination schedule. After vaccination, the patient experienced severe shivering, back pain and a mild fever during the night.