chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; body aches; chills; headache; tiredness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 28-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:00 as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Vyvanse. The patients historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, administered in Arm Right on 09Feb2021 11:30 AM as 1st dose, single for covid-19 immunisation. Patient previously took Amoxicillin and experienced known allergies. It was reported that patient did not had Covid prior to vaccination nor been COVID tested post vaccination. On 02Mar2021, the patient experienced nausea, body aches, chills, headache and tiredness. Patient was not received any treatment for the events. The outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.
4/28/2021 COVID-19 Positive Breakthrough Case >14- Days Post Vaccination Series Completion Narrative:
Patient reported for his second vaccine and states within an hour and a half of receiving his first vaccine he experienced substernal chest pain and radiated to his left chest and arm.  Chest pain was associated with shortness of breath.  Patient reports pain occurred daily for 3 weeks following vaccine and it significantly impacted his daily living.  He did not seek any sort of medical care for these symptoms.  Symptoms had resolved when he presented for his second dose, but second dose was not given.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Two hours later the patient"couldn't move that arm". The physician was concerned that he might have injected the vaccine into a tendon or a joint. Unspecified medical attention was sought. Additional information has been requested.
Extremely cold hands; Extremely cold feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet). At the time of the report, PERIPHERAL COLDNESS (Extremely cold hands) and PERIPHERAL COLDNESS (Extremely cold feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
parents noted redness & swelling of feet & knees, ears & body & neck a few hr p/dose 3;pt has 3+ widespread urticaria, w/redness & swelling of knees & feet;
Pt called approximately 7 hours after receiving vaccine. Said she was experiencing swelling, itching, and redness at the immunization site. Pt has had influenza shots in the past with no history of reactions, however this was the first time she had received the high dose influenza vaccine.
SWOLLEN DELTOID AREA AND HEADACHE.  SWELLING IN DELTOID LASTED FOR 2 DAYS TO THE EXTENT THAT IT WAS PAINFUL TO DO DAILY ACTIVITIES.  EMPLOYEE DID NOT CONTACT EMPLOYEE HEALTH FOR FOLLOW-UP.
Maternal exposure before pregnancy; SARS-CoV-2 infection; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension (worsening) since 01-Jan-2007. Concomitant products included LABETALOL and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. The patient's last menstrual period was on 31-Dec-2021 and the estimated date of delivery was 30-Sep-2022. On 22-May-2022, the patient experienced COVID-19 (SARS-CoV-2 infection). On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 24-Sep-2022, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, COVID-19 (SARS-CoV-2 infection) outcome was unknown and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, Pregnancy test: Positive. On 22-May-2022, SARS-CoV-2 test: Positive. In 2022, Ultrasound scan: No abnormalities.         Treatment medications were not provided. Company Comment: This is a spontaneous case of Maternal exposure before pregnancy, concerning a 37-year-old female patient with no relevant medical history, who experienced the non-serious unexpected, event of COVID-19, which occurred approximately 6 months after a dose of mRNA-1273 vaccine, received as the second dose for COVID-19 vaccination. Patient was vaccinated with mRNA-1273 vaccine approximately one month and 10 days before last menstrual period date. The cesarean delivery was reported as Full-term. The outcome for neonate was reported as Delivered. The outcome of event COVID-19 was unknown. No further information was disclosed.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-646081 (Patient Link).
Joint, bone and body pain for 2 weeks after.  I am now dealing with ongoing left lower back/hip alignment.  My lower back dislocates and sits on my nerve causing pain down my left leg to my toes.  No relief with OTC, stretching, chiropractic, standing or laying down.  Unable to sleep in any position.
Information has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK) lot number M023935 with expiration date on 08-DEC-2018 (it was reported that the improperly stored vaccine was reconstituted with properly stored sterile diluent (MERCK). On 02-OCT-2017, the patient was vaccinated with an improperly storage dose of ZOSTAVAX lot # M042851, with expiration date on 18-OCT-2018 (strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 6 Fahrenheit (°F) to 14° F, during a time frame of 2 hours and 30 minutes. It was confirmed that the vaccine had previous temperature excursions of 15° F to 46° F for 2 hours and a digital data logger was involved.
My glucose rose into the high 200s and I was told by my doctor to increase Lantus night time to 16 units accordingly
pt recv vax 8JAN98 & 23JAN98 pt devel soreness approx 1 inch around inj site;pt also noted no pox & sore to touch;
Pt received below vaccines on 5/24/06. Mom states by the time she got home he was lethargic and cry sounded funny. Mom stated his tongue looked swollen and like it was in the way. She just watched him that night. He woke up screaming several times that night. Mom reports that he normally sleeps through the night. Around 4am mom states he woke up screaming and had a rectal temp of >102. Mom called pediatrician on call due to the tongue swelling and fever. She was told to take pt to the ER. Mom reports that fever was down and he was acting better when they got to the ER. Mom felt they were dismissing her claims. They sent her home and told her just to watch him. Mom called back today 5/26/06 stating his tongue is still swollen but he is afebrile. Mom states he is sleeping ok, breathing normally. Per Dr, mom advised ok to give Benadryl 1/4 tsp Q 6 hrs as needed if he is having breathing problems. Mom verbalized understanding. /21/06-4page ER report received from Provena Mercy Center-ER visit-exam at 0640 revealed normal ENT-DC Diagnois fever. RX Tylenol
Pt recvd 1st dose of vax 08MAY91 & was uneventful; pt recvd 2nd dose of vax 12JUN91 & 16JUN91 exp skin eruptions, malaise, itching, fever, strep throat, chills, joint pain, & serum sickness; treated w/meds; MD advised not to complete series
The patient's mother informed my team lead of an allergic reaction. The patient developed a rash on her left, lateral, lower leg. The rash was warm to touch with red, raised bumps. The child was not in distress, she had no pain and responded no when asked if it itched. After doing a head to toe exam, I found the patient was A/Ox3, PMS x3 and airway was open. The patient was administered (1) children's chewable benadryl. The mother was advised to follow up with a pediatrician and monitor her child for any other developing symptoms.
Patient presented with large bruise rash, and redness with warm tender arm. Called patient MD and patient follow up with MD.
Arm/shoulder pain and difficulty with arm movements that has not diminished. Flu like symptoms that subsided after a week, however extreme lethargy daily.
Tightness in throat, seen by EMT, waited15 min,unchanged, left 9:05 am
This spontaneous report was received from a Registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates, unspecified number of patients received ZOSTAVAX, 0.65 ml, (indication and lot numbers were not reported) subcutaneously that underwent a supported temperature excursion. No adverse experiences reported. No product quality complaint was involved. Additional information has been requested.
She got the shot on her left arm and started experiencing soreness on 30OCT2023.; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3080536) for COVID-19 prophylaxis.     Patient was not diagnosed with COVID-19.  Previously administered products included for Product used for unknown indication: Flu shot on 06-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Breast cancer metastatic since 2011, Allergy to chemicals and Drug allergy.    On 29-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.). At the time of the report, INJECTION SITE PAIN (She got the shot on her left arm and started experiencing soreness on 30OCT2023.) had not resolved.            It was reported that patient had receives previous vaccines four weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  NDC number of the suspect vaccine was 80777-0102-93.  It was reported that She got the shot on her left arm and started experiencing soreness on 30-Oct-2023. This was her fifth dose and she did not remember ever experiencing a sore arm like this with her previous doses. She had received all Moderna COVID-19 vaccines in the past. She said that her arm was still sore at the time of reporting and she was surprised that it would last this long. She reported that the intensity of the soreness had remained the same over the days and had not gone down. She could not do much when she needs to mover her arm, as it hurts. She said that she felt throbbing in her arm. She had never had this issue with other her previous doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747942.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747942:Monovalent case
Client's varicella titer results was non-immune 9/21/10. October 5, 2010 administered VZV subcutaneous right arm. October 14, 2010 shot site red and broke out with 6 bumps, 1 bump on back, and 4 bumps on left arm and itching. Saw Dr. on 6/18/10 diagnosed as chicken pox. Must stay out of school for 1 week.
A report was received from a health care professional on 12/2/03 concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates until 12/1/03 vaccinees inadvertently received Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
swelling in legs and feet on both sides; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in legs and feet on both sides) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling in legs and feet on both sides). At the time of the report, PERIPHERAL SWELLING (swelling in legs and feet on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  It was reported that patient not taking any medications and did not receive any treatments
Patient received FLUZONE HIGH DOSE 2016-17 flu shot on 10/10/16 and complained of shoulder/arm pain on 10/12/16. Patient reported incident to pharmacy on 11/11/16. Patient has appointment with his physician on 11/22/16.
The next morning I woke up feeling achy all over and my forehead felt hot. My temperature vacillated between 98.7 and 99.9 for approximately two to three hours. I also had a headache, loss of appetite and slight nausea; no vomiting.  I started feeling better in about 5 hours. I woke up the next day feeling fine.
sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR178217).   On 20th August 2021, the patient received the 2nd dose of Shingles vaccine. On 21st August 2021, 1 days after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On 22nd August 2021, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient just got second shot on Friday. The patient was sick the next day after first so the patient expected to be sick 21st August 2021 as well and sure enough the patient was. The patient reported that on the day of reporting all was well. This case has been linked to US2021AMR178143, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178143:comment response case US-GLAXOSMITHKLINE-US2021AMR178217:Same reporter
Moderna COVID- 19 Vaccine  Moderna Lot #012L20A  January  2021 left deltoid  CC: Itching reaction, remote to the site of Moderna vaccination, 26 hrs post-injection  47 year old  presents with rash rt. thigh on 1-7-21 at the  Health Services, Employee Health  Received Moderna Covid 19 mRNA vaccination #1 yesterday 1-7-21 at 8:50 am, left deltoid. Noted itchy area on rt. thigh ~ 26 hrs post-vaccine. No trouble breathing, no throat or facial swelling, no h/o problems with vaccination, no h/o anaphylaxis. No new topical exposures. No new supplements, no recent antibiotics. Denies fever. She apparently rubbed/scratched through pant leg, when felt itching, and then saw a bruised/red area after this.  Exam: Skin: 5 xc 10 cm nonblanching petechial and ecchymotic area rt. ant. thigh, no papules or pustules, no warmth to touch.  Pt. encouraged to register with V-safe. Rec. oral anthistamines as directed/needed.  I spoke with patient on 1-11-21, no new itchy areas, still using Benadryl for the localized itchy area that she reports is resolving.  Was harm caused: employee is fine. Difficult to say if this is vaccine reaction vs. coincidental occurrence.
Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 UNDERDOSE (Patient received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient.
Dizziness, Headache, Pain In Injection site., fatigue,cognitive delay, anxiety with tremor in hands Narrative:
05/22/2000 2.5 mm erythematous heart shaped lesion on left upper anterior thigh, neg. pain.
Swelling at the vaccine injection site Overlying dermatitis Hydrocortisone 2.5 % External Ointment 1 application topically to the affected area 2 times per day x 1 week (start date: 10/6/2023)
Pt recv vax & devel inj site rxn w/redness,swelling & pain. Pt seen by MD 2 days post vax.  At that time, redness & swelling had extended to the elbow. Tx w/antibiotic
Headache, tiredness, feeling sick,  unbalance 25 hours later they started.   Headache and tiredness continued 3rd day. Just I am getting rest.
Tachycardia, hypertensive episode within 2 minutes. Diarrhea, flushing, and palpitations about an hour later, and later that afternoon. Diarrhea, dizziness, fatigue, and palpitations the afternoon of 4/2/2021.
Breakthrough case admission after 5 vaccines pfizer 2/24/21 Lot# EN6202;  Pfizer 3/17/21 Lot# En6204;  Pfizer 9/24/21 Lot# FF2588;  Pfizer 7/9/22 Lot# FP7150;  Pfizer 9/14/22 Lot# GH9702
Seen 18nov05-swollen left arm/ hand.  Seen 21nov05- 3+ pitting edema progressed to MCP joints. Treatments---rx for Prednisones 18nov05--pt took 1 dose; "got shakes" & stopped taking it.  21nov05-- rx for Zyrtec; patient instructed to follow up x 1 week.
9AUG96 swelling rt deltoid w/ax node enlargement approx 1 1/2cm diameter w/temp, mildly tender;nl movement of hand & arm;19AUG96 pt sc completed resolved p/ 4 days;
She lost her voice; She experienced chills; She experienced headache; She experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (She experienced chills), HEADACHE (She experienced headache), PYREXIA (She experienced fever) and APHONIA (She lost her voice) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN, VENLAFAXINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (She experienced chills), HEADACHE (She experienced headache) and PYREXIA (She experienced fever). On 13-Mar-2021, the patient experienced APHONIA (She lost her voice). At the time of the report, CHILLS (She experienced chills), HEADACHE (She experienced headache), PYREXIA (She experienced fever) and APHONIA (She lost her voice) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication were not provided.
flu symptoms; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on 05Feb2021 13:15 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunization. Medical history included irritable bowel syndrome and zinc allergy. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient experienced flu symptoms after the second dose on 27Feb2021 07:00. The events were reported as non-serious. The patient did not receive any treatment for the events. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
feeling hot; stomach aches; throat aches; head aches; general malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2; Formulation: Solution for Injection) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "feeling hot"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach aches"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "throat aches"; HEADACHE (non-serious), outcome "unknown", described as "head aches"; MALAISE (non-serious), outcome "unknown", described as "general malaise". Action taken for bnt162b2 (BNT162B2) was not applicable.  No follow-up attempts are possible. No further information is expected.