chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He reported to his mother on August 27, 2011, that he had been having chest pains for about two weeks but was afraid to tell her. This is because he plays football and thought she may not allow him to play. But the pain had gotten increasingly worse and more severe and he was now scared he was having a heart attack. He complained of feeling like someone was sitting on his chest and shortness of breath. Mother checked his pulse, which was normal. Mother assumed it was muscular due to football equipment or possible hit to the chest during practice? We were under hurricane warnings so mother monitored him until Monday morning and took him to his primary doctors office. There he was evaluated by his doctor. They performed an EKG. The EKG was abnormal. Doctor ordered mother to take him to emergency room. Once there, they too administered another EKG, which was also abnormal. The E.R. doctors also ordered a chest xray, echo, bloodwork and urine drug screen. All of those tests aside from the EKG were normal. Patient was discharged and told his heart was perfectly normal and they could not explain what was causing the chest pains or the abnormal EKG's.
Started with fatigue; by 01/22 I was getting nasal congestion; 01/24 I started coughing and the congestion entered my chest.  Since then I have upper respiratory pain and congestion and am coughing up yellow phlegm.  Still have head congestion.
I am experiencing itchiness--Thumb side of both arms; top of both thighs; back of neck; scalp; lower belly.  I do not see any rash
After the patient received the vaccination, she experienced persistent itching all over her body that has endured for over 2 weeks.
Rash that extended to her chest and torso; Chills; Pain; A spontaneous report was received from a Health care professional concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash that extended to chest and torso/rash, chills and pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Jan 2021, Monday, approximately 2 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 039k20a) for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced chills and pain. On 06 Jan 2021, the patient experienced rash that extended to chest and torso.  Treatment details included capsules of diphenhydramine  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, rash that extended to chest and torso, chills and pain was resolving (helped with her symptoms).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Per the patient the site of injection became swollen, painful, and red the day after she received her immunization.  Patient was advised to follow up with her physician.
October 7,  2021 ; 26 year old male patient received his second Covid 19 vaccine, Pfizer. Pt states he started having symptoms of nausea, dizziness, and feeling warm after 5 minutes of receiving the vaccine. Pt denies of having symptoms during his first dose. Pt's vitals were: 134/78 ; 60 Hr ; 14 RR ; 97 SPO2. Pt was transported to ER by personnel. Pt did not receive EPI.
Given after expiration date, will call and inform client and let them know will need to revaccinate
Patient came in for a COVID Moderna booster (.25) but received  full dose(.5)
Arm is swollen, tender to touch, warm (left arm). Was given Keflex 500 mg QID for 10 days.
p/vax pt exp a swollen lt parotid gland gradually extending from behind the lt ear to the front of the neck, dysphagia, low grade temp, lethargy;sx became worse then began to subside;pt sought unspecified medical attention;
Pt recv vax on 12/18/98; on 12/19/98 pt exp rash at vax site, face, neck, arms -pruritus x 48 hr; tx=Benadryl
Sedation, Myalgia, Diarrhea, pain and chills also reported Narrative:  Employee notes approximately 48 hours of COVID like symptoms, similar but milder than what they experienced with the infection. Noted extreme fatigue, pain, diarrhea, chills and muscle aches with resolved after approximately 48 hours.
Red rash and swelling around the injection site as well as itching. The rash covered the entire arm.
Swelling and redness at injection site. Painful  and warm at injection site. Swelling in arm pit/bicep area. Red ring around bicep approximately 1-2 inches below injection site swelling.
Over a week later, I feel like getting the flu for the last three days ( today as the third day). My face feels hot to me, but is not hot to the touch. I am feeling like I might throw up. I have been home and wearing a mask and staying six feet away from people when I leave home since March 16, 2020. It is highly unlikely that I caught any illness from another person.
This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients of unknown age. On numerous unspecified dates, numerous unspecified patients were vaccinated with VAQTA (dose, strength and frequency not provided). VAQTA was improperly stored. This is one of several reports from the same source. Additional information has been requested.
No adverse event; HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 1 Monovalent (6month-5years) and batch/lot number: Unkown) on 28-Mar-2023. Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine.    On 28-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 28-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose) 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 WRONG PRODUCT ADMINISTERED (HCP states that a 9 month old patient received the Moderna COVID-19 bivalent vaccine from the incorrect vial for his 2nd dose).    No concomitant medications were reported. The patient received Moderna COVID-19 bivalent vaccine (for 6months-5years) from the incorrect vial as a  2nd dose, resulting in a lower than authorized dose. Reporter wants to get guidance on how to proceed with this patient. The patient was not reported any adverse reactions at this time. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2023: Live non significant follow up received
epilepsy; Information has been received from Food and Drug Administration (FDA) in response to request on 04-FEB-2022.  This spontaneous report was received from a consumer who was patient's parent, guardian or caregiver, and refers to a 16-year-old non-pregnant female patient. Her concurrent conditions included type 1 diabetes. The patient's concomitant medications included insulin lispro (HUMALOG). She was reported to be allergic to peanuts. No information regarding the patient's medical history was provided.  On 21-DEC-2017, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# N0015089 upon internal validation was established to be not valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) and does not match any Company product, expiration date was not provided; dose and site were not provided), administered intramuscularly (IM) for prophylaxis.   On 12-SEP-2018 at 09:30:00, the patient experienced epilepsy (reported as seizure diagnosed as epilepsy), and as a result visited emergency room or urgent care (also reported as doctor or other healthcare professional office/clinic visit). The patient was treated with levetiracetam (KEPPRA). The outcome of the epilepsy was reported as not recovered.  The causality assessment relationship between epilepsy and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The Agency considered the event to be non-serious.  Follow-up information was received from a clinical supervisor via an inbound telephone call on 16-MAR-2022. The clinical supervisor was unable to locate a patient for this case as there were several females age 16 that were administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on the day this anonymized patient received her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccine. No additional information was available.
Pain, swelling, tenderness at injection site.  Muscle pain in body, headache and nausea started several hours after injection and lasted about 24 hours.  Fatigue lasted into second day. Fever and chills started about 12 hours later for about 6 hours. (Some of  symptoms at injection site may have been a result of the administration of the injection.  There was some blood at the site and I still have a black and blue mark)
Headache, body ache, chills , high fever 102 even while taking Tylenol, extreme tiredness and pain at injection site
HEADACHE/HEAD HURTING; FELT NAUSEA; FELT FATIGUE/TIRED; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 08-APR-2021, the subject experienced headache/head hurting. On 08-APR-2021, the subject experienced felt nausea. On 08-APR-2021, the subject experienced felt fatigue/tired.  Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/62 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache/head hurting, felt nausea, and felt fatigue/tired. This report was non-serious.
inflammation, irritation on the place of the shot, redness, pain 8 days after shot and for 48 hours
Immunizer was unable to puncture the patient's skin with the needle. Immunizer stated that the needle was too dull to puncture the skin, 2 attempts were made then syringe was discarded into the sharps. Patient was immunized using a new syringe and needle.
Extreme muscle aches and feeling like flu with sharp zinging pains in ears,  neck, etc. Extreme sore arm...still after week it's still sore, Main complaint is : Raised my blood glucose to over 200"s no matter what I ate or didn't eat at all. This lasted almost a week.
The pt experienced macular rash on cheeks, forehead, chin and ears. Few patches on and behind left ear.
Left arm red, swollen, est. 4 x 5" diameter. Began 4-11-16 afternoon (same day as injection).
Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; Patient had a reaction at the site of injection: swelling, redness and blistering.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE VESICLES (non-serious), outcome "unknown" and all described as "Patient had a reaction at the site of injection: swelling, redness and blistering.". Additional information: Reporter is asking if these are significant side effects.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
Pt experienced initial reaction at pharmacy - started with cough, hives and then lump in throat.
Atarted violently throwing up about 30 hours after vaccine on both 1st and 2nd dose.
Patient was receiving second dose of Moderna. Upon injecting the vaccine, the vaccine came out of the hub of the syringe. Per nurse, most of the vaccine came out and barely anything was administered. Pharmacist aware and gave the nurse the ok to redose the patient. Patient aware and comfortable with administration.
Bad chills and muscle aches, intermittent for 30 hours, controllable with Tylenol and ibuprofen around the clock. No fevers. Mild localized arm pain. Mild cough.
"9/29/2022 - Right Supraclavicular and Cervical Lymph node swelling and tenderness.  Contacted and reported symptoms to Oncologist office via online patient portal.  Instructed to monitor 10/4/2022 - Regular scheduled appointment with Oncologist.  Swollen nodes confirmed by Dr.  Instructed to continue to monitor nodes.  Also received monthly dose of Immunotherapy (Tecentriq) that same day. 10/14/2022 - Noticed swelling and tenderness of lymph nodes underright jaw and ear.  Contacted Dr. office again to report symptoms.  Per onsite pharmacist, studies have shown swollen nodes up to months after bivalent booster.  Will continue to monitor
A report has been received from a Health Professional concerning a patient born on 02-May-2004, male subject who had been receiving FLUMIST. FLUMIST started on 28-Sep-2013. Registered nurse reported that a patient received FLUMIST twice, one and one half months apart. The outcome of the event of patient received FLUMIST twice is unknown. The report was considered to be non-serious.
SORENESS; NAUSEA; INTENSE HEADACHE; This spontaneous report received from a consumer concerned multiple patients. 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) dose was not reported, administered on 20-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced nausea, intense headache, and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, intense headache and soreness was not reported. This report was non-serious.
it made her sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (it made her sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (it made her sick). At the time of the report, ILLNESS (it made her sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  It was reported that patient got the Moderna COVID-19 Vaccine and it made her sick.  Treatment information was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Paralysis R side of face, ER visit 11-30-09. Dx with Bell's Palsy, Sx started 7 days after 2nd dose of H1N1 flumist. Patient still can't blink and close eye. ER gave eye drops.
This spontaneous report as received from a mother regarding her 50 years old son with Williams Syndrome. On 16-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On 16-APR-2013, the patient developed a pin size brown spot at the site of the injection. The patient had no pain at the site. The patient sought no medical attention. Diagnostic test performed was none. No treatment was given. The outcome of the event was not recovered/not resolved. Additional information is not expected.
FAILURE TO THRIVE/POOR WEIGHT GAIN; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an infant female. The patient's mother was enrolled in a non-company sponsored study. The patient's weight was 2.83 kilograms, and height was 21 inches. No concurrent conditions were reported. The patient's maternal medical history included multi gravida, low blood pressure. Concomitant medications included prenatal vitamins. Maternal obstetrical history included one previous pregnancy that resulted in live baby. The mother of infant had no history of tobacco, e-cigarettes, alcohol or recreational drug use. Maternal first day of the last menstrual period (LMP) was calculated to be 25-JUN-2020. The estimated delivery date (EDD) was reported to be 01-APR-2021. Type of pregnancy was not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number and expiry date was not reported) dose was not reported, 1 total administered on 12-MAR-2021 at gestational age 37 weeks and one day for covid-19 immunization, which was foetal exposure during pregnancy. The batch number was not reported and has been requested. Concomitant medications included minerals nos/vitamins nos for drug used for unknown indication. At gestational age 39 weeks and one day, the mother delivered a live, full-term, female neonate by cesarean method of delivery (C-section). Primary reason for C-section was previous C-section. The mother spent three days in hospital for the delivery. On an unspecified date in MAR-2021, Laboratory data included: Hearing test Not Reported. On an unspecified date in MAR-2022, at 12 months, the baby was diagnosed with failure to thrive/poor weight gain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy, and had not recovered from failure to thrive/poor weight gain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and failure to thrive/poor weight gain, and foetal exposure during pregnancy as not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210726934.; Sender's Comments: V0: 20230916594-Failure to thrive/poor weight gain. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
arm swelled from my elbow to my shoulder; injection site arm itched; injection site left arm is sore; Physician told me not to receive the second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched), VACCINATION SITE PAIN (injection site left arm is sore) and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched), VACCINATION SITE PAIN (injection site left arm is sore) and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine). At the time of the report, PERIPHERAL SWELLING (arm swelled from my elbow to my shoulder), VACCINATION SITE PRURITUS (injection site arm itched) and VACCINATION SITE PAIN (injection site left arm is sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Physician told me not to receive the second Moderna Covid-19 vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on 05-Aug-2021.       Concomitant medication of the patient was not reported.  The patient went to urgent care and an allergic reaction to the Moderna COVID-19 vaccine is confirmed. The patient was given a steroid cream to put on the arm.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is  expected.
Pain/Discomfort and swelling at injection site, tiredness for 12 hours Narrative:
Within eight hours of Friday vaccine, I had chills, fever, vomiting, diarrhea, chest tightness, and body aches, like a severe case of flu. I phoned an after-hours doctor at 9pm and was told to take fluids and Tylenol. She felt I presented as food poisoning plus the effect of the vaccine.  She did not feel it was Covid related. Highest fever was 101 degrees. It came down the afternoon of the next day.  I was weak, nauseated and achy through Sunday and diarrhea continued through Monday. I called the after-hours line again on Saturday, and was told to isolate, but no Covid test was needed.
Oth complications following immunization, NEC, init on 2015-08-07.
fever, chills, headache, swollen left arm, armpit is swollen, knot at base of neck on left side
Left arm swelling and redness, evaluation clobetasol 0.05% top cream x 2 weeks.
On Day 3-6, patient suffered from fever, nausea, chills, headache and malaise.  On day 9, the patient developed a generalized papular rash similar in apprearance to roseola, initially asymptomatic, but developing intense pruritis over the next 2-3 days.  Surrounding the vaccination site on the left deltoid area was intesnse erythema and edema.  Fevers, headache and malaise continued for the next 4-5 days concomitant with the rash.  On day 15, the rash began to lose it's widespread distribution and erythematous nature, lightening into a pink color.  By day 18, the rash was completely gone as well as all systemic symptoms.  Fever was always low-grade, not exceeding 100F.  At no time did the patient require airway management. He was treated effectively on an outpatient basis with Atarax and Tylenol.  He has made what appears to be a full recovery, the wound site appears intact and appropriate for the given innoculation timeline.  The scab has not yet fallen off as of today.     MY DIAGNOSIS WITHOUT THE LUXURY OF LOCAL DERMATALOGIC CONSULTATION IS GENERALIZED VACCINIA.