chrisvoncsefalvay/vaers-outcomes huggingface dataset:
have 2 kids that enlarged heart from this vaccine now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the parent.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "have 2 kids that enlarged heart from this vaccine now".  Additional information: The reporter had 2 kids that enlarged heart from this vaccine now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201188653 same reporter/drug/AE, different patients;
Patient complained of feeling dizzy and hands tingling. One set of vital signs taken but patient refused a second set of vital signs. Patient felt fine after speaking with the medical doctor and went home.
On 10/9 patient received Tdap, Hep A, HPV, MCV4, and Varivax after the Varivax patient's arm swelled slightly and turned red. Ice was applied, swelling went down. Patient was discharged on 10/12 patients mother called arm still swollen and hot to touch patient was sent to ER.
Got long covid; Got long covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 "Got long covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: already was starting to test negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Tiny speck of blood in mucousy stool; black flecks in stool.
COVID - 2nd injection given - not given IM -  given high to R upper arm (administration error)   pt with severe pain and redness/ warmth
Syncope: passed-out in for a few seconds and bladder incontinence. I am suspecting either neurogenic syncope vs. cardiogenic syncope.
Within a minute after receiving her vaccination, she initially felt lightheaded and had a brief episode of syncope the last approximately 30 seconds. She slumped  in her chair, was caught and had no head trauma. She was taken to a private section of the arena and monitored. Her blood pressure and heart rate were within normal limits.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid vaccine (dose 5), for covid-19 immunisation; Covid vaccine (dose 4), for covid-19 immunisation; Covid vaccine (dose 3), for covid-19 immunisation; Covid vaccine (dose 2), for covid-19 immunisation; Covid vaccine (dose 1), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was given from 29Oct2023 to 02Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About ½ hour after the vaccination, the tip of my tongue felt bruised and a little while later it began to swell, I put ice on it for 2 hours and by the time I went to bed it was all gone. And I?ve not had any other problems with it.
Developed red raised itchy rash on left upper arm (deltoid) extending down approx 4? down arm from where injection was given; symptoms first started 1/27/21 at approx 8pm. Treated with cold compress. Rash decreased by next morning (8am) but quarter sized red, blotchy area remained at that time.
Woke up with low grade fever 99.9. Felt low back pain, chills, arm pain, and fatigue. Took Tylenol 1000 mg and Naproxen 440mg. Symptoms decreased around 5pm and fever subsided around 9pm.
RED WELTS IN ABDOMINAL AREA AND ARMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On APR-2021, the subject experienced red welts in abdominal area and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red welts in abdominal area and arms was not reported. This report was non-serious.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 037A21B), on 25Apr2021 as dose 2, single (Lot number: 04b21A), on 01Apr2022 as dose 4 (booster), single (Lot number: 048L21A), on 30Sep2022 as dose 5 (booster), single (Lot number: AS7163B) and on 19May2023 as dose 6 (booster), single (Lot number: AS7164B) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "hypertension" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A and 076C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose and Lot no. 1805031) on 14-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Latex allergy.   On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses/vials were 26 doses. The reporter reported that, the expiration date was not written on the vial and did not noticed it had already expired.  The vaccine stored in fridge on 17-May-2022. The vials did not undergo any temperature excursion.  No treatment medications were reported.
31MAR98 rash devel into full case of chickenpox greater than 30 @ this time;
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were inadvertently vaccinated with doses of improperly stored VAQTA (lot # was reported as M006708 (invalid) with expiration date 02-JUN-2018, dose and route were not reported). The vaccine was improperly stored at 34.7 Fahrenheit for 2 hours 30 minutes. It was reported that there was previous temperature excursion. Data logger was involved. No adverse effect was reported. Additional information has been requested.
Administered Moderna 0.5 mg IM Left Deltoid for 2nd Booster in err.
Lost taste; Lost smell; Got very sick; This spontaneous case was reported by an other caregiver and describes the occurrence of AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick) in a 63-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick). At the time of the report, AGEUSIA (Lost taste), ANOSMIA (Lost smell) and ILLNESS (Got very sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid infection.     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.   This case was linked to MOD-2021-071416, MOD-2021-072067, MOD-2021-070997, MOD-2021-077195, MOD-2021-071383 (Patient Link).
She called and states she has had left shoulder pain for past 6 months and that's the only that it could be, and states her family member has had similar symptoms.
This is a spontaneous report from a 62 year old female pt who in approximately early June 1999, received her 1st dose of Lymerix. Shortly thereafter, she experienced a very sore arm and had difficulty lifting with it. The pt considered not receiving the 2nd shot of Lymerix. The most recent information on 7/2/99, reports the symptoms resolved.
Per client he experienced chest pressure 4hrs after receiving vaccine that lasted 4hrs. Per client no shortness of breath during this time, did not take medication, and did not seek medical help.
Mother alleges pte began with itching, redness and rash in left arm at noon on 05/26/2017. No medication nor emergency visit was required.
High fever. Chills, severe body aches, severe headache, nausea, diarrhea, ring in my ears
This is in follow-up to report(s) previously submitted on 10/6/2007. Information has been received from a licensed practical nurse reporting on her child, a 1 year old male, who was vaccinated with PROQUAD (Lot #656310/1394F). A month and a half after being vaccinated with PROQUAD, the patient experienced "for approximately three days", 100-150 chickenpox, decreased appetite and vomiting. The patient had no fever as well as no scabs. Unspecified medical attention was sought. The patient recovered. No further information was provided. No product quality was involved. Additional information has been requested. Follow-up information on 27-AUG-2007. During a follow-up phone call the patient's mother (licensed practical nurse) provided the lot number for the administered vaccine Lot #656310/1394F. Informatin has been received from a licensed practical nurse concerning a 14-month-old also reported as 16-month-old male with otitis media chronic who on 13-JUN-2007 was vaccinated in his left leg with his first dose of MMR II (+) VARIVAX (Merck) (Lot # 656310/1394F) at 09:00 hours. There were no illnesses at the time of vaccination. On 27-JUL-2007 at 16:40 hours the patient experienced 100-250 chickenpox and broke out in rash all over body, decreased appetite, vomiting, diarrhea and fever up to 102.5. The patient sought unspecified medical attention. On 06-AUG-2007 the patient recovered. Additional information is not expected.
Child sitting on dad's knee, leaning against him; seconds after injection, child slumped to right side, was unresponsive.  Called child's name, shook shoulder; placed him on floor. Respirations continued. He was unresponsive for 40-45 seconds; eyes fluttered and his body twitched several times; not indicative of seizure but tonic/clonic muscle twitching.  No evidence of seizure activity but slight hesitation when answering questions. Limited neuro exam preformed; vitals started with oxygen at 1L by non-rebreather mask; legs elevated on chair. Alert and oriented times 3; no loss of bowel or bladder. Vitals taken every 1-5 minutes for next hour remained stable.  When he sat up he experienced slight nausea; crackers, juice and water provided.  Oxygen removed after 7 minutes; saturation level remained stable at 97% on room air. When he was moved from floor to chair after 18 minutes he experienced nausea increased; cold pack placed on neck, wrist pulse points, forehead.
Leg cramps, swelling (R>L)- bothered her varicose veins- feel like she has developed planter fasciitis.
pt recvd vax 22SEP93; pt had a nl PE & has had no react to prev immun; w/in 1 hr following vax pt became feverish, crying, wouldn't eat or drink or move arm; mom did not monitor temp;
This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a adult female patient who received ENGERIX B (batch number 94522 ?, expiry date 4th September 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced diarrhea and headache. On an unknown date, the outcome of the diarrhea was recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the diarrhea and headache to be related to ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced severe liquid diarrhea and headache for a full day after receiving their first dose of ENGERIX B. No further details were provided by the pharmacist.
She is itching like crazy; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (She is itching like crazy) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (She is itching like crazy). At the time of the report, PRURITUS (She is itching like crazy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
Started having diarrhea 5 days after injection.  Profuse diarrhea started 8 days after injection.  Urgent care took a blood sample; white and red blood cell counts were normal.  Inflammatory indicators were elevated.
Pt presents with palm sized red area surrounding injection site indurated, warm to touch. Left leg Varivax given. Tx: Augmentin 4 wks 3 lg Hp BID, Benadryl 1 tsp 96 hours
he could not move his hands easily, felt like paralyzed; he could not stand up; A spontaneous report was received from a consumer concerning a 86-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and he could not stand up, he could not move his hands easily and felt like paralyzed.  The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and brimonidine tartrate/timolol maleate.  On 02 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.   On 03 Mar 2021, he could not stand up, he could not move his hands easily and felt like paralyzed.  Treatment for the events was not provided.  Action taken with mRNA-1273 in response to the events was unknown/not reported.   The outcome of the events, could not stand up, could not move his hands easily and felt like paralyzed, was considered recovering/resolving.; Reporter'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.
Received anthrax vaccine #5 in the afternoon of 11/19/03. It was given subcutaneously on his left arm, near the triceps. He reports waking up the next morning with redness, swelling, warmth and tenderness from his left shoulder to his elbow, and almost the around the entire circumference of his upper arm. His charge nurse sent him to the ER the p.m. of 11/20/03 for evaluation. He denies significant fever, muscle or joint pains, lymphadenopathy, or headaches. Reaction completely resolved within 7-10 days. Denies significant local reactions following anthrax vaccines 1-4. In December 2003, noted pruritic "knot" at vaccination site. Nodule was nontender and not accompanied by any lymphadenopathy or skin color or temperature changes. No drainage. Nodule lasted about 5 days and resolved without treatment. Reports nodule has reappeared about once/month and lasts about 3-5 days. Last nodule appeared in July and lasted about 3 days.  Nurse follow up on 10/19/04 states: "Per review of ER record, patient was not admitted. Therefore AE was non-serious. Admitting diagnosis was r/o cellulitis. No final diagnosis was stated, but Keflex was prescribed and infection at injection site."
Tachycardia, Hypertension, Weight loss, Insomnia, Fatigue 11/23/19-present
CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to peg.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache. This report was non-serious.
12AUG93 or 13AUG93 dad states pt fell backward & eyes rolled back & then had hard cry; 14AUG93 dad states pt tripped over toy, fell on to a couch, made a whimper, then started to shake "jerky shakes" for approx 5 mins; took to ER;
Developed intussusception 8/7/11. Had 4 ROTATEQs.
Pt started complaing of headache/SOB about 10mins after the vaccine, VS  157/98, 73 98% 02 on RA, 174/97, 68, 97% on RA 15mins interval, Blood sugar 222 but she had breakfast already. Daughter said she took allergy pills along side BP meds just before coming to the clinic. Even though after 45mins of Post vac Patient verbalise she felt better. Her daughter was educated to take her to her Dr's office due to uncontrolled BP and headache. She verbalize understanding.
Ever since Friday, April 2nd I've been experiencing symptoms of cold urticaria. My skin will break out in extreme hives once I'm exposed to cold. It happened for the first time on April 2nd when I was in my car and the air conditioner was blasting on my right arm. My right arm broke out in severe hives from the bottom by my hand up to the top by my sleeve of my shirt. I also went on a walk in about 57 degree weather and my neck, lips, arms, hands starting breaking out in hives. After I came back inside the hives went away within 5-10 minutes. When I hold cold items my hands/fingers will swell up. It has now been happening the past 2 weeks. I haven't changed my diet or done anythinng different other than the vaccine.
This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 05-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001714: US-009507513-1706USA001724: US-009507513-1706USA001720: US-009507513-1706USA001725: US-009507513-1706USA001729: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001728: US-009507513-1706USA001719:
Within 8 hrs of IZ developed a couple of patches of papular erythematous rash. Next am rash was from head to toe. Treated with Benadryl 12.5/5 1-1 1/2 tsp Q 6 PRN rash. Aveeno over the counter.