chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I sat for 30 minutes post injection to make sure there was no reaction because of history of reaction to a medication.  I was fine after my time. I left and within 5 minutes of leaving there I began to have left sided facial numbness with no other symptoms that subsided and completely went away. Within an hour of injection, I started to feel dizzy but continued with my day and went to work where the dizziness only got worse through the night. After getting home from work my whole body was starting to hurt and shake, during the night I was getting what I took as the normal side effects that lots of people were getting. Fever chills shaking body aches but continued to be extremely lightheaded and dizzy. When I woke in the morning of 1/21/21 I now had right sided facial numbness but no droop indicating Bell's Palsy. All the symptoms but the dizziness and facial numbness went away those two lasted for three weeks at least. I then went to the Walk In Clinic to get checked out where they did a COVID swab and an EKG and everything was fine told me I had vertigo. When this continued, I was then seen at my PCP's office.
Mast Cell Activation Syndrome (MCAS); Life has been miserable since then; I don't leave the house; This serious, initial spontaneous safety report from the country was received by Novavax on 29-SEP-2023 from a consumer, via the contact center and customer experience center.  A female of an unspecified age and race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine unspecified dose (booster) on an unreported day in OCT-2022.  Medical history included Polymers allergy (polyethylene glycol), so the individual had Allergy to other unspecified COVID-19 vaccines, and Drug hypersensitivity to Paxlovid (nirmatrelvir, ritonavir).  No concomitant medications were reported.  On an unspecified date, reported as by JAN-2023, the individual developed mast cell activation syndrome (MCAS) (PT: Mast cell activation syndrome) (Serious: Medically Significant). Since an unspecified day in JAN-2023, her life had been miserable, and she didn't leave the house (PT: Feeling abnormal).  At the time of reporting, the event outcomes of Mast cell activation syndrome and Feeling abnormal were not recovered/not resolved.  Lot number was not provided in the report.; Sender's Comments: This female of an unspecified age experienced: Mast cell activation syndrome and Feeling abnormal after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Mast cell activation syndrome was reported as serious. The event Feeling abnormal was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Chronic pain the lower spinal column every morning for the last month or so Chronic pain in the Sternum every morning;  When I would have a arthritis flair up they would normally last 2 or 3 days, not it's every morning, I wake up normally around 3 a.m. with pain my lower back and sternum .
One and a half weeks post vax, the infant was noted arching his back, spastic twitching in sleep, seizure like movement, and irritable. Infant was admitted for rule out infantile spasms, physician felt he was experiencing gastrointestinal discomfort.
"Sleeping in between formula feedings on day 5 10 hours however wakes up finish 5oz of formula (Good appetite, smiles but "lethargic" x 3 days). Seen in office admitted complete sepsis work up done to rule out other illnesses. Antibiotics started and discontinued after 48 h. Negative culture.1/2/09-records received for DOS 12/9-12/12/08-DC DX: Hypotonia hyporesponsive episode secondary to pertussis vaccine. Sepsis and meningitis ruled out. Presented with complaints of lethargy.
Temperature of 101-102 for 24 hours. One hour extreme sweating and heat flash the next hour shakes and being very cold for over 24 hours.  Aches through my entire body.  Took Tylenol and Advil, water and electrolytes.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date). On 26-Jan-2022, EXPIRED PRODUCT ADMINISTERED (2 doses of the Moderna Ciovid-19 vaccine were given past the expiration date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information was not provided. Did the vial undergo any temperature excursions: No. This case was linked to MOD-2022-461874 (Patient Link).
Fever, Chills, Body Aches, Low Oxygen Level, Headache, Cough
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (mango, pineapple, strawberries, nuts), Asthma, Anxiety, Depression and Migraine. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), MAGNESIUM, COLECALCIFEROL (VIT D3) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was 24-Jun-2021. On 03-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 03-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included, stool softner medicines were reported.  Treatment information was not provided.   This case was linked to MOD-2021-240807 (Patient Link).
Patient bruised instantly when given shot she also felt dizziness after careful uncertainly she felt fine except her arm was sore.
18 year old patient that received an adult dose of VAQTA instead of the pediatric dose; No additional adverse events; This spontaneous report was received from a medical assistant and refers to an 18-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #U013476, expiration date: 06-FEB-2022, administered for prophylaxis (strength, exact dose and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event was reported.
Rash started at groin and moved up body per mother. Pt seen in office, Red chickenpox like lesions. Supportive care given.
tasted it; she had a sore right arm; headaches; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (tasted it), VACCINATION SITE PAIN (she had a sore right arm) and HEADACHE (headaches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (tasted it), VACCINATION SITE PAIN (she had a sore right arm) and HEADACHE (headaches). On 16-Aug-2021, HEADACHE (headaches) had resolved. At the time of the report, DYSGEUSIA (tasted it) and VACCINATION SITE PAIN (she had a sore right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported. Patient reported that she is not the kind of person who gets headaches.   This case was linked to MOD-2021-343895 (Patient Link).
Patient said she developed SIRVA after receiving her flu shot on 8/28.  She can't move her arm
has not completed the series to date; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter askeddid  they only get 1 more dose now or did they need to start the 2-dose series again.  The reporter have received varying answers from the providers and nursing staff in his office.
UTI.  No prior urinary tract illness in patient history. 24hr after symptoms began, tests showed >50 WBCs and >50 RBCs in  urine sample. Symptoms included blood in urine, pain at end of urine stream.  No fever.
Flu like symptoms, fever, chills, vomiting, body aches, extreme fatigue. All lasted for approximately 36 hours. Still experiencing fatigue and cold sweats when moving.
pt recv vax 29SEP95 & 9MAR97 pt devel a moderate case of chickenpox accompanied by itching & presented to MD on 12MAR97;pt recovered by 15MAR97;
pt recv vax & that evening had a petite sz (froze up to 5 to 10min was really out of it & pale for 30min;then went to sleep;mom felt that was the end of it;2mo later had grand mal sz;now has devel delays;
2 inch wide by 4 inch long reddened & warm area on the back of patient's right arm, noticed while mother was bathing patient. c/o mild itching, denies pain. No treatment yet.
At the site: My arm from elbow down swelled, ring finger and pinky finger on right hand curled under, burning sensation down shoulders, arm, right back, pressure in right ear, swelling on outside of neck, larynx changed vocal sounds, tension like skin swelling on face. Tingle in hands. BP rose.  At home: Above plus muscle aches and fatigue. Took an Aleve Saturday which helped. Sunday at home: More of aches but nothing major. MONDAY MORNING  - symptoms of lymphs swelling, tightness in neck, larynx issues, wheezy breathing, felt like ate glass and then a bowel movement, pasty throat, could push down lymph on right side, metallic mouth. Pasty back of throat, Pressure from right tonsil. miserable. Pressure point in head. Went to hospital.
Lost apatite for a day; Really tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eye disorder.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day). On 07-Jan-2021, DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080012:Dose 2
PATIENTS ARM IS VERY SORE AND SWOLLEN, SHE IS UNABLE TO LIFT ARM. THERE IS NO HEAT RADIATION, REDNESS OR ARIWAY CLOSURE.
pt recvd vax on 10FEB93 & am 11FEB93 some hives on face & the thigh; hives for face disappeared; 1/2" hive below OD & 1/2" hives on thigh; also rt OM;
tested positive for COVID 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID 19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced COVID-19 (tested positive for COVID 19). At the time of the report, COVID-19 (tested positive for COVID 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD21-089296, US-MODERNATX, INC.-MOD-2021-118513 (E2B Linked Report).; Sender's Comments:  MOD21-089296:Mother's case US-MODERNATX, INC.-MOD-2021-118513:
This spontaneous report as received from a 80 year old female patient concerning on herself with no drug reactions or allergies. In 2007 the patient had been vaccinated with ZOSTAVAX (route, lot number and expiration date not reported). Concomitant therapies included famciclovir, capsaicin and tramadol hydrochloride. On 08-JUN-2013 the patient got a case of the shingles. The episode came on her legs above the knee, ran from the knee to the torso. swelling, hotness. Got 2 blisters on each leg, mostly was nerve pain. Unspecified treatment was given for the event. No lab diagnostic studies were performed. The patient sought for unspecified medical attention. The outcome of the events were unspecified. Additional information is not expected.
30 min /p vax pt began to have sxs:nasal stuffiness,puffy eyelids,trouble breathing,scattered weazing,itchy&watery eyes& swelling &redness @ inject site.Attending MD admin Epinephrine&Susphrine &sent pt home.Pt's mom phoned"all sx subsided"
inj site rt anterior thigh red, warm to touch;inflammation approx 5x5cm;
Patient became dizzy, weak and woozy/nauseous.  He reported that he may have passed out for a quick moment.
feeling symptoms and that she felt like she had the flu; felling sick; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EY1685), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported receiving Pfizer Bontech covid 19 vaccine on 18Dec2020. She was feeling symptoms and that she felt like she had the flu (Dec2020). Consumer further stated she work here at the Hospital and Friday she appeared for the shot (Covid Vaccine) and she was just felling sick (Dec2020) and she didn't know what she had to do if it was normal, she had to report it to somebody for this or be around people or can she went back to work tomorrow, she didn't know. The outcome of the events was unknown.  No follow up attempts are possible. information about lot/batch number cannot be obtained.
This spontaneous report as received from other health professional (Medical Assistant) refers to multiple unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates since January 2016 (Onset approximated to 2016), the patients were vaccinated with improperly stored doses of GARDASIL injection (lot # K026247 with an expiry date 29-JAN-2017) (doses and frequencies unspecified) intramuscularly. No adverse effects were reported. It was reported that vaccines were not discontinued. This is one of the several reports received from the same reporter. Additional information has been requested.
NO ADVERSE EVENT.  DOING BOOSTER/FLU CLINIC AND PHARMACIST ADMINISTERED BIVALENT PFIZER SHOT. AFTERWARDS WE FOUND OUT THIS WAS ACTUALLY THE PATIENTS FIRST COVID VACCINE.
muscle aches on my whole body; This is a spontaneous report from a contactable consumer reported for himself. A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3248, Expiration date was not reported), via an unspecified route of administration of left arm on 20Jan2021 10:45 as single dose for covid-19 immunisation. Relevant medical history reported as none. The patient concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Patient experienced muscle aches on whole body on 22Jan2021 12:15 am. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient did not receive treatment for the adverse event. The outcome of the events was recovering.
Left ankle swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left ankle swollen) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced JOINT SWELLING (Left ankle swollen). At the time of the report, JOINT SWELLING (Left ankle swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
2/16/2021, CLIENT NOTICED RIGHT EYE SWELLING WHEN RETURNED HOME FROM VACCINATION AT 1200 PM.  EYE ALSO LOOKED BLOOD SHOT.  CLIENT APPLIED COLD MOIST COMPRESS TO EYE.  BY EVENING, SWELLING WAS GONE BUT SCLERA PINK AND LIGHT SENSITIVE.  THIS AM, 2/17/2021 EYE IS A LITTLE PINK YET, NO SWELLING.  HAS NOT AFFECTED VISION.
1hr p/vax arm swelled @ inj site, had hives lasting 24hr;did not seek medical care, or call clinic;report information obtained from another person & pt contacted feeling well now
Patient reported redness and itching at injection site and wanted it looked at. At or near injection site he had a small, approximately 1/8" x 1/8" scabbed over sore. No redness surrounding the sore He reported some tenderness on touch. I recommended keeping clean with soap and water and antibiotic ointment could be applied if he wanted.
Difficulty swallowing; Headache; Stiffness in limb; Pain; Chills; Blister on lip; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: 6N6808), via an unspecified route of administration in the left arm on 21Mar2021 at 14:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient previously received sulphur (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), salbutamol sulfate (VENTOLIN) and fluticasone propionate, salmeterol xinafoate (SERETIDE); all for an unknown indication from an unknown date. Prior to vaccination, patient was not diagnosed with COVID-19. since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 21:00, the patient experienced difficulty swallowing within seconds of the vaccine, headache and stiffness in limbs and pain, blister on lip after chills. It was unknown if the patient had received any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events difficulty swallowing, headache, stiffness in limbs, pain, chills and lip blisters was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Slight arm soreness after first vaccine dose.  Fatigue, loss of appetite, diarrhea started the evening after the second dose on 1/10/21.  Symptons varied in intesity over next few weeks.  Facial and other edema and 20 lb weight gain noted 1/28/21.  BP 230's/120's at doctors office. ER then ICU. Kidney biopsy. Auto immune (PLA2R) membranous nephropathy diagnosed.
Rash on face, trunk. Legs developed within 10 minutes of immunizations. Was given 0.2 ml Benadryl IM 15 minutes after immunization. Mom felt Prevnar #2 may have caused slight rash-undiagnosed. Rash resolved within 20 minutes.
3/09 woke up feeling terrible with fever, chills, congestion, fatigue, coughing, and body aches. Reached out to OB/GYN and was told OTC meds I could take. Symptoms persisted for two weeks. All symptoms have resolved except for cough. Went to walkin clinic and was prescribed augmentin. Still having shortness of breath and coughing
trouble breathing 24 hours after 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-May-2021 and was forwarded to Moderna on 07-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 DYSPNOEA (trouble breathing 24 hours after 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced DYSPNOEA (trouble breathing 24 hours after 2nd dose). At the time of the report, DYSPNOEA (trouble breathing 24 hours after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
SWELLING OF EYES; SWELLING OF FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of eyes. On 09-MAR-2021, the subject experienced swelling of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of eyes and swelling of face was not reported. This report was non-serious.