chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOTS; This solicited report received from a consumer via PPSCVM000808: Janssen CarePath for XARELTO concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported,  1 total, administered 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 patient experienced blood clots and not sure what was causing it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was not related; and between rivaroxaban, and blood clots was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210627971- covid-19 vaccine ad26.cov2.s-Blood Clots-This event is considered un-assessable. This event 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 events.
Vaccine given @ approx. 2pm @ approx 6pm. Rt knee starting hurting then about 12:30 AM severe itching started @ neck and head. Rt hand and eyes swollen. Employee event to clinic @ 12pm on 11/19/2008, given Benadryl injection.
I started having what I thought was indigestion about 4:30 pm. on March 31st. During that night I could not lay down without pain and had to sleep in a recliner. I thought it might be muscle pain because I had exercised that day. I did not want to take Motrin since I was getting my second Covid 19 shot the next day and it said not to take Motrin before getting the shot. At about 3:00 am I couldn't take the pain any longer and told my husband to take me to the emergency room. While I was there they did many tests and finally said I had pericardiatis. They told me that I could not get my second Covid 19 shot that day. I was very disappointed. I was able to leave the hospital at about noon on April 1st. I was told to go to a cardiologist and have an echo done. I went to the cardiologist on
Erythematous itchy rash over chest, face and exacerbation of pre-existing eczematous lesions over the fumor aspects of elbow, wrists and knees and ankles. Treated with Benadryl.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peat of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Fevers, chills, body aches, nausea, vomiting, diarrhea, pain, swelling. redness in right arm. Symptoms started on Wednesday 10/30/13 at 1800.
Woke up with blisters in upper palate.  Later in day started experiencing backache.  On 10/17 began throwing up with low grade fever accompanied with headache.  As of today (10/22) have upper chest/sinus congestion, headache, sores in mouth, vomiting, general body aches, low grade fever.
red, itchy welts all over back and left side of body - same side as arm where vaccine was administered.  Started feeling itchy around 9 p.m. on 4/5/21, awoke around 1 a.m. on 4/6/21 with extreme itchiness, got up and put Benedryl cream on rash area, and fell asleep again.  Awoke 7:30 a.m., 4/6/21 and rash and welts were warm to touch, welts raised.  Took a Benedryl and drank lots of water.  Itchiness subsided within an hour - welts disappeared within 2 hours, redness disappeared by end of day.
Following vax pt developed anterior area of mid thigh erythemic sl induration 4-6cms; Temp, muscular strength intact, knee flexing resistance a-post immun localized rash;
After receiving the vaccine, 30 mins later. I started feeling dizzy with a rapid heart rate. I started feeling really weak and delirious. Then I had a really bad headache with nausea and fatigue.  Then I eventually laid down and fell asleep for about an hour, I had a headache and the other symptoms were gone. All of the symptoms lasted about 3 hours.  The headache was the only symptom that lasted longer, about 6 hours.
Sudden onset of tinnitus followed by complete hearing loss in Right ear upon awaking from sleep (7 hours)
Itching,Wheezing, blotchy rash on face and neck,Swelling in throat  Started one hour after injection.  Took 25 mg Benadryl PO  when no relief repeated the Benadryl. 1:00 went to ED where she had Decadron, Breathing treatment with Albuterol and Atrovent. Prednisone 60 mg Po X4 days.
Mom called clinic @ 7PM 5FEB92 c/o pt having t105 R; mom gave further info that pt had t102 @ 4PM gave APAP; when pt woke skin very warm pt was irritable & listless; mom told to give APAP, sponge bath STAT;
Pentacel that was 4 days expired administered to a patient, no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was inadvertently vaccinated with an expired 0.5 mL second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (frequency once) lot C5552AA, expiry date: 14-Oct-2019 via intramuscular route in left thigh on 10-Oct-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Covid symptoms continues even after tested negative after taken Paxlovid; (08Aug2022) Positive, notes: tested again with a home kit on 08Aug, and it was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient reported his Covid symptoms continued even after being tested negative after taking Paxlovid. Because of the symptoms, he tested again with a home kit on 8Aug2022, and it was positive. He had four doses of vaccines over the last 1 and 1/2 years. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 areas that were stung by wasp were reactivated by vax, 2 areas hard knotty areas. all were fevered.
This spontaneous case reported by a consumer, describes the occurrence of exposure via breast milk (breastfeeding) in an 8-month-old infant, of an unknown gender, exposed to mRNA-1273 (Moderna COVID-19 vaccine), while the mother received the product for COVID-19 immunization. Medical history of parent: The mother's past medical history included maternal exposure during breast feeding on Feb 9, 2021. No medical history reported. On Feb 9, 2021, mother received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Last menstrual period and estimated date of delivery not provided. On Feb 9, 2021, infant diagnosed with exposure via breast milk (breastfeeding). At the time of the report, exposure via breast milk (breastfeeding) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use not provided. Reporter did not allow further contact. Sender's comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
She stated that a two month old received Kinrix [DTaP + polio] injection instead of Infanrix on 24-Jul-2023; 2 month patient received Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-week-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 24-JUL-2023, the patient received Kinrix (intramuscular, left thigh). On 24-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: She stated that a two month old received Kinrix [DTaP + polio] injection instead of Infanrix on 24-Jul-2023) and inappropriate age at vaccine administration (Verbatim: 2 month patient received Kinrix vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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: 21-AUG-2023 The reporter was a medical assistant. The reporter reported that the 2 month old patient received Kinrix vaccine instead of Infanrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter reported that, they were intending to administered Infanrix and inadvertently administered Kinrix instead of Infanrix, which led to wrong vaccine administered. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
pt recv vax 15MAY96 & 28MAY coworker thought pt had chicken pox-broke out & started on zovirax;lesions dried out w/in a wk;no sequelae;
fever; rigors; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of   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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Entire body broke out in a skin rash and hives 8 days following first dose of Moderna.  Hives lasted approximately 4 days. Treatment included anti-histamines.
acute cellulitis at injection site, that spread to the entire upper arm. and chest.  Extreme fatigue, loss of appetite, headache, nausea, back/renal pain.  continues to worsen.  physician prescribed keyflex.    It was given concomitantly with Pneumovax-23 (Merck) lot T031820, same  left deltoid.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not provided) as prescribed and/or administered by a pharmacist for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, she was treated by a healthcare provider for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX) vaccine, she had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. the relatedness between the event and zoster vaccine live (ZOSTAVAX) was related.
Patient received vaccine, reports that she had "chills, shakey, trembling, difficulty thinking, breathing fast"
Pt had no adverse reaction.  Form being completed due to expired vaccine being given. Originally the vial was pulled from the freezer and placed in the refrigerator on the morning of  8/25/2021.  Vial's seal was punctured at 8/25/2021 at 4:02pm and would expire at 4:02am and injection was given on 8/26/2021 at 1:11pm Vial was left in refrigerator after seal was punctured. Vial was only at room temperature for approx.. one minute while medication was being drawn up.
I received a positive PCR test result on 1/28/21.  That positive COVID result was 18 days after my 2nd dose.  I just wanted to report that I still got COVID after I was supposed to be fully inoculated.
RN gave shot at 2:45 pm, pt went to work at 3:00, began to notice chest getting tight and SOB. Pt told other staff who passed it off. One employee told he to contact RN at 3:48 was reported to RN. RN told her to get to her employee Nurse office where she work. PT looked okay no rash not cyanotic, but pt said chest felt tight and she couldn't breath, Rn took her to ER at 3:50 (where she works). The gave Xopenex breathing treatment 3:55 and IV Solumedrol 125 mg at 3:50. They watched her gave her a prescription for Medrol dose pack. Pt went home at 5:00pm released into care of aunt who is LPN (works at hospital too), Pt said she was fine when she left, no chest tightness, no SOB. RN told her to never take a flu shot again. Pt mother was deceased about 1 month ago Others said PT RN did not believe it to be from cancer.
Hives, urticarial like rash. BENADRYL 5ml Q 6 hrs.
pain in my upper back/left upper back; Left arm, left hand pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain). At the time of the report, BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain) had not resolved.            Concomitant medication of the patient was not reported.   The patient received the booster shot at 2 pm on Friday but still getting pain in upper back ,left arm, left hand pain, left upper back.. When the patient was sitting or driving the pain become a little unbearable.  No treatment information was provided by the reporter.
Swollen lymph nodes causing soreness and pain in left armpit. Started morning of this report.
ANA level result was high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "LUPUS" (unspecified if ongoing), notes: The Mother has a friend who has LUPUS. The patient's concomitant medications were not reported. The following information was reported: ANTINUCLEAR ANTIBODY INCREASED (non-serious), outcome "unknown", described as "ANA level result was high". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter added in the past, her Daughter experienced drug induced LUPUS from minocycline and was on Prednisone for 2 years, when she was 16 years old and has been fine ever since. She discovered this when they went to the dermatologist. Her Daughter's head was shedding from the COVID-19 and the Mother asked about her hair, blood work was ordered and completed and the dermatologist reported the ANA level result was high and advised to see a Rheumatologist. The Mother has a friend (patient) who has LUPUS. The Mother shared with her female friend (patient) what her daughter was experiencing and the patient reported the same thing happened to her after she got her Pfizer COvid-19 Vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reported feeling dizzy s/p IM injection. She was assisted to a seated position on the floor, no LOC, no diaphoresis s or other signs of syncope. VS at 1438 as follows: BP 111/68, HR 100, sats 98% on RA. Pt given water and snacks. Repeat VS at 1448 as follows: BP 108/73, HR 82, sats 98% on RA. Pt recovered within 15 mins and ambulated out of clinic.
Sweating; Soaking in bed; can't stand; feeling fuzzy; intermittent numbness in face; Pain; pain, tenderness, and swelling in arm; pain, tenderness, and swelling in arm; shivering/chills; High fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy) and HYPOAESTHESIA (intermittent numbness in face) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 1 dosage form and ACETAMINOPHEN for Fever, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (Sweating), NIGHT SWEATS (Soaking in bed), DYSSTASIA (can't stand), FEELING ABNORMAL (feeling fuzzy), HYPOAESTHESIA (intermittent numbness in face), PAIN (Pain), TENDERNESS (pain, tenderness, and swelling in arm), PERIPHERAL SWELLING (pain, tenderness, and swelling in arm), CHILLS (shivering/chills) and PYREXIA (High fever) outcome was unknown.            Relevant concomitant medications included BP medications, thyroid medications,diabetic medications. Action taken with mRNA-1273 in response to the event was not applicable
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 30-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 which included Paxlovid from 06Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321236 Same patient/ reporter, different drug/events;
Approximately 3 or 4 min after Dtap; IM injection in L deltoid, there was a localized swelling about 3cm x 1 1/2cm whitish raised area above the injection site. Approximately 1/2 inch above. Child observed x 25 min. Area very slightly raised
Lip/Tongue tingling, headache, severe abdominal cramping, diarrhea, hives.