chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED AN OPENED VIAL 6 HRS PAST ITS INITIAL PUNCTURE; MULTIDOSE WAS ADMINISTERED; OPENED VIAL WAS LEFT IN THE FRIDGE AT 41F FOR OVER 6 HRS; This spontaneous report received from a pharmacist concerned a 21 year old male. 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: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced administered an opened vial 6 hrs past its initial puncture. On 06-MAY-2021, the subject experienced multidose was administered. On 06-MAY-2021, the subject experienced opened vial was left in the fridge at 41f for over 6 hrs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered an opened vial 6 hrs past its initial puncture, multidose was administered and opened vial was left in the fridge at 41f for over 6 hrs was not reported. This report was non-serious.
Patient states she had pain and redness at injection site. Patient is sending me pictures of her arm and injection site.
Diarrhea up to ten times a day for one week after vaccine; nurse at doctor's office said illness wasn't related to vaccine. Baby was better for 1 day. Then the next day became ill again with rash, fever and respiratory symptoms; again doctor's office said unrelated to vaccine but illness has continued from 11/23/11 to present on 12/12/11 - child is still sick!
He had a severe pain in his right big toe, it was diagnosed to likely be gout. At first you did a telehealth appointment through 98.6 Clinic. They prescribed Prednisone and Indomethacin. His symptoms improved and then came back. He then went to urgent care where they gave him a cortisone injection in his toe. Which helped it get better, until second vaccine.
itchiness in my chest/lungs; "tickle in her throat"; Mild itchy throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT ("tickle in her throat"), THROAT IRRITATION (Mild itchy throat) and PRURITUS (itchiness in my chest/lungs ) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity (Sensitivity to MSG(monosodium glutamate)). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT ("tickle in her throat") and THROAT IRRITATION (Mild itchy throat). On an unknown date, the patient experienced PRURITUS (itchiness in my chest/lungs ). At the time of the report, OROPHARYNGEAL DISCOMFORT ("tickle in her throat") and THROAT IRRITATION (Mild itchy throat) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: ADR Form
Patient had vaccine on 9/11/23 and woke up to a rash all over body, including face. Patient describes rash as small, flat, red and itchy spots. Patient was seen at a walk-in clinic and treated with hydroxyzine and cetirizine on 9/22/23. Still has not resolved as of  9/25/23. Going to see provider/physician on 9/26/23.
Injection site red, inflamed and erythematous, nontender to palpation in a 5 cm x 5 cm area.
APPROXIMATELY 3-5 MINUTES AFTER RECEIVING THE VACCINE THE PATIENT SUDDENLY PASSED OUT - SHE HAD NO WARNING - SHE CAME BACK ARROUND IMMEDIATELY - FEELING A LITTLE DIZZY FOR A FEW MINUTES AND THEN FINE - THERE WAS NO TREATMENT OTHER THAN COLD COMPRESSES TO THE FACE.
hoarse voice, throat swelled up, hard time swallowing.  happened approximately 35 min after the injection.
Patient was supposed to receive the HPV vaccine but the pharmacy administered the Pneumovax 23 vaccine, according to the patient's report to our clinic
Mild mental queasiness with several hours of sustained blood pressure elevation during a severe chilling of extremeties requiring flannel pajamas & robe, wool socks, down comfort and topped by electric blanket for 2 hours.  Transient, mild temperature elevation (2 degrees).  This event occurred  3/18/21   (26 days after dose#2.).
Severe headache, full-body aches, swelling under the right armpit, muscle soreness on the complete right side (especially from the right breast down to waist), chills, and major sweats (enough to make my clothes wet), and stiff neck.
Fever, Body ache, sore arm.  24 hours following injection 1 week later, started developing Shingles symptoms, culminating in full rash/sores on April 11.  Rash is healing but still present on April 21.  Official diagnosis is Shingles.
Breakthrough case admission after 3 vaccines Moderna 2/10/21 lot# 01520A;  Modern 3/10/21 lot# 030A21A;  Moderna 1/4/22 lot# 066H21A
muscle, joint pain; muscle, joint pain; weakness; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset Sep2023, outcome "not recovered" and all described as "muscle, joint pain"; ASTHENIA (non-serious) with onset Sep2023, outcome "not recovered", described as "weakness". Additional information: Patient was vaccinated with the Pfizer on Friday at 1:40 (as reported) and had reactions it was not very severe but it has been going on now since Friday and patient was wondering if it is normal and how will these reactions normally lasts. Patient stated, "I did not pain at all but you know muscle, joint pain and the general weakness and just weakness. Bad time, I get such a bad time because my nephew lives in (City name withheld) in (State name withheld) and I am not going to be able to go to (withheld) today so that is why and I appreciate your time and help and I just wanted to thank you for giving me that number and I will call tomorrow."   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
While caring for another patient, I heard a code green called at a different location within the clinic. I ran to the location to find patient lying on the floor with the monitor standing next to her consoling her. Patient was awake alert and oriented times four but did not remember what happened. Slight redness located on the upper right forehead. Code Green called, EMTs arrived at scene and continued evaluation.
Tested positive for COVID-19; The day she received the vaccine she had sore arm.; A spontaneous report was received from a 57-year-old health care professional, who was also the patient, who received Moderna's COVID-19 vaccine and experienced a positive COVID test and injection site pain.  The patient's medical history included a negative test for COVID-19 on 29 Dec 2020.  No concomitant medications were reported.  On 28 Dec 2020, the patient tested negative for COVID-19.    On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number 025620A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced injection site pain after getting vaccinated.    On 02 Jan 2021, the patient experienced COVID-19 with symptoms including runny nose and a little cough.  On 04 Jan 2021, the patient tested positive for COVID-19.  No treatment information has been provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, a positive COVID test and injection site pain, was not recovered/resolved.; Reporter's Comments: This case concerns a 53-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025620A), and who experienced the non-serious unlisted event of COVID-19 and the non-serious listed event of Injection site pain. Based on the known safety profile and temporal association between the use of the product and the onset of the event Injection site pain on the day of vaccination, a causal relationship cannot be excluded and the event is assessed as possibly related to the vaccine.  Based on the absence of COVID-19 virus capable of causing infection in the vaccine, the event of COVID-19 is assessed as unlikely related to the vaccine.
Reviewed over phone. Itching and rash started about 26 hours after immunization first on face and then at about 36 hours after itching on back, arms stomach and ears. Patient tolerating and was able to sleep and has been advised to take cetirizine 10 mg 2 twice daily taper as improves and follow up if worsening symptoms. Anticipate improvement
Red spot around the injection site.  Gradually increased over the next 2 days. Now the area is 6cm of erythema, slightly swollen, no induration, no pain, no fever.
2:25 patient states that feel Light headed. denies any other side effect .BP  118/76, HR 99, SPO2 96 ON ROOM AIR. 2:50 Patient denies light headed and states feels much better.. BP  116/82, HR 63, SPO2 96 ON ROOM AIR.
patient received pediarix instead of Infanrix/ had gotten 3 doses and received Pediarix as 4th dose; patient received pediarix instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4n2pm, expiry date 28-MAR-2025) for prophylaxis.   Previously administered products included Pediarix (had gotten 3 doses on an unknown date).   On 14-JUL-2023, the patient received the 4th dose of Pediarix. On 14-JUL-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: patient received pediarix instead of Infanrix/ had gotten 3 doses and received Pediarix as 4th dose) and wrong vaccine administered (Verbatim: patient received pediarix instead of Infanrix). The outcome of the extra dose administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jul-2023 The reporter consented to follow-up. The patient was meant to be Infanrix (4th dose) but Pediarix was given instead, which led to extra dose administered and wrong vaccine administered.
Lymph nodes under both arms are swollen- happened March 29 and continues today Nodules  above diaphragm and all under  left & right breast
DEATH; This spontaneous report received from a consumer concerned a 60 year old African American, Not Hispanic or Latino male. 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) dose was not reported, 1 total administered as approximately on 26-Mar-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021, the patient died from unknown cause of death. It was reported that, the patient death occurred about 6-7 days after receiving the vaccine. It was unknown, if an autopsy was performed.  The patient death occurred about 6-7 days after receiving the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210416142-covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
12 hours after immunization, began to feel nauseous and dizzy - could not stand up. He went from shivering to feeling hot. He went to urgent care and received IV fluids, and he thinks injections of anti-nausea med and maybe a steroid. Symptoms subsided 12 hours after onset, but he took 2 days off of work to recover.
ADMINISTRATION ERROR: SECOND  DOSE OF JANSSEN COVID-29 VACCINE  ADMINISTERED PRIOR TO LABEL  UPDATE FOR BOOSTER DOSING; OFF LABEL USE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, 212AZ1A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021, and dose was not reported, administered on MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administration error: second dose of janssen covid-29 vaccine administered prior to label update for booster dosing. On 24-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error: second dose of janssen covid-29 vaccine administered prior to label update for booster dosing and off label use was not reported. This report was non-serious.
inappropriate schedule of vaccine administered; coughing until throwing up; fever; chills; floating headache; coughing until throwing up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH, PYREXIA, CHILLS, HEADACHE, and VOMITING in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, tested positive for COVID in December 2020. Previously administered products included for Product used for unknown indication Pfizer (Dose 1 Batch number EN5318) on 03-Apr-2021 and Pfizer (Dose 2 Batch number EW0161) on 24-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Blood pressure high, Hypercholesterolemia, Smoker and Smokers Cough.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced COUGH, PYREXIA, CHILLS, HEADACHE, and VOMITING. On 29-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. The patient was treated with IBUPROFEN at a dose of the first day and ACETAMINOPHEN at a dose of the second night. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, COUGH, PYREXIA, CHILLS, HEADACHE, and VOMITING was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) In December 2020, SARS-CoV-2 test tested positive for COVID.         Patient stated that  she did not experienced these events with Pfizer doses.  Concomitant medications include for blood pressure and cholesterol.  Patient had bad reactions to the vaccine. It was reported that on 01-Dec-2021, patient felt better.
Pt. had syncopal reaction immediately after receiving GARDASIL vaccine. She recovered within 2-3 minutes, no head trauma, returned to baseline.
Tired, foggy, feels like I have a cold coming on, achy, sleepy, loss of appetite
Numb hand 3 days after, few weeks later pins and needles in feet, numb legs
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 at 03:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "difficulty breathing" (unspecified if ongoing), notes: Other medical history: difficulty breathing leading to constant use of steroids; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "known allergies: penacillin" (unspecified if ongoing), notes: known allergies: penacillin. The patient's concomitant medications were not reported. Past drug history included: Amoxacillin, reaction(s): "Allergy: amoxicillin", notes: Known allergies: amoxacillin; Cotrim, reaction(s): "Allergy: cotrim", notes: Known allergies: cotrim; Augmentin, reaction(s): "Allergy: augmentin", notes: Known allergies: augmentin.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient received paxlovid treatment for COVID-19 on 13Jun2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial report received from a health care professional in the USA on 04 December 2006. A 35 year old female patient complained of pain down into her elbow, bruising around the site, 5 days after she received Decavac (lot number U1786CA), intramuscularly in the right deltoid on 25 October 2006. The patient received a "Flu shot" on 24 October 2006. On 01 November 2006, the patient was still in pain. On 20 November 2006, she complained on pus coming out of injection site. On 22 November, a prescription was given for pain. At the time of vaccination, she was being followed-up for her thyroid. Follow-up information received on 12 January 2007 from a health care professional. The patient complained of "a lot of pain in the arm where TD was given" Her right upper arm was red and indurated, and very tender to palpation. There was no fluctuance and no streaks. She was treated with Vicodin 5-500 mg every six hours as needed for pain. During a general encounter visit on 05 January 2007, it was noted that the patient was doing much better and had not complain of arm pain. She recovered from the events. Additional information is not expected. This case has the same reporter as case 2006-03339.
Case previously recorded as MA2009-6439. We received the following information via Medical Communications (MedCom) from a physician on 30 NOV 2009: Three patients younger than four received a dose of S-OIV FLUVIRIN (batch number 1007369P) i.m. on an unspecified date. Despite multiple attempts to obtain details such as patient initials the reporter declined to provide additional information. No adverse effects were reported. This case concerns one of the three patients for the other two children please refer to cases MA2009-6438 and MA2009-6440. MedCom ref. no.: NA09-008948.
Welps at injection sight, axillary lymph node swelling, swollen lymph nodes in neck and shoulder pain
pt recv vax 23AUG96 & 6SEP96 pt devel more than 20 lesions which were not @ the inj site;@ time time of the report, pt had no other sx;reporter was not certain if pt exp was r/t vax;
Patient complained of itching, erythema, and a rash on her right arm at the site of her Gardasil vaccine and reports the symptoms began one day after receiving the vaccine.  She reports the itching resolved after use of an OTC hydrocortisone cream and states the rash has not spread.
Estimated delivery date-10/24/21 Patient was offered flu vaccine during prenatal visit, Pt accepted. Patient filled out Influenza Screening  Questionnaire. Flu vaccine administered, when documenting, we noticed patient had been given flu vaccine on 09/30/21. Pt received 2 flu vaccines. Patient has been informed by provider. Instructed patient to monitor any symptoms or side effects and to report to us if any occurs. Patient verbalized understanding.
get horribly sick after a flu shot; allergic to an ingredient in the delivery medium; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).  This case involved an adult patient of unknown gender for whom it was reported had got horribly sick after a flu shot (illness) and was allergic to an ingredient in the delivery medium (allergic reaction to excipient), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient had had got horribly sick after a flu shot (illness) and was allergic to an ingredient in the delivery medium (allergic reaction to excipient).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown.  There will be no information available on the batch number for this case.
Gave vaccines and 5 minutes later patient passed out from a seated position in chair. Elevated leg, lay on exam table, was drowsy for several mins. Gave juice and crackers. Cold compress applied to neck and ice to bump on forehead. Within 15 mins was able to stand but was still pale. Returned to laying on exam table for about 15mins. Then he was feeling  better and was able to leave clinic with mother after provider checked on patient again. Precautions given by  PA  since patient did hit his forehead.
Numbness in left arm and face. Burning/raw feeling in (on) left arm.  Initial reaction to shot was fine. I waited 15 minutes and had a "weird" feeling in my left arm and ring and pinky fingers. Once I started walking to my car I noticed that my cheeks were feeling different. My tongue felt larger than normal as I was driving home.  For most of the day my left side from roughly my armpit down my arm and the left side of my face felt different.  Not quite numb, but not normal.  Spent most of the day resting in bed. The raw/burning feeling lasted until Sunday (shot was on Saturday). The injection site looks great. No swelling or itching.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demography. Pertinent medical histories, drug reactions, allergies and concomitant medications were not provided. On an unknown date in August 2016, the patients were vaccinated with (wistar ra 27-3) M-M-R II lot # L024266 (dose, frequency and route of administration were not reported) and therapy for unknown reason which were improperly stored (incorrect product storage). No symptoms reported (no adverse event). There were no previous excursion of temperature. Temperature was 48 F, time frame was 72 hours and no data logger was there. The outcome of incorrect product storage and no adverse event were unknown. This case is linked to case WAES1608USA010175 (same reporter link). Additional information has been requested.
Narrative:  Finished second COVID-19 Pfizer vaccine on 2/2/2021 and admitted on 8/1/21 with COVID-19 infection.