chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very sore in arm/near injection; Very sore in arm/near injection; overall body aches; slight fatigue; slight headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 16:45 as dose 1, single (Lot number: HG4677) at the age of 46 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; OMEGA [CONVALLARIA MAJALIS;CRATAEGUS LAEVIGATA;PROXYPHYLLINE]; TURMERIC [CURCUMA LONGA RHIZOME]; B12-VITAMIIN; RETINOL; IVERMECTIN; RESTASIS; IUD NOS; COLLAGEN. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GH9694, Location of injection: Arm Right), administration date: 03Oct2022, when the patient was 45-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Right), administration date: 15Dec2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 30Apr2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache"; bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 09Apr2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "Very sore in arm/near injection", "Very sore in arm/near injection", "overall body aches", "slight fatigue", "slight headache". The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 12Oct2023 at 09:00, outcome "recovering" and all described as "Very sore in arm/near injection"; PAIN (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "overall body aches"; FATIGUE (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "slight fatigue"; HEADACHE (non-serious) with onset 12Oct2023 at 09:00, outcome "recovering", described as "slight headache". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, pain, fatigue, headache.
That evening after vaccine area was sore, unable to raise arm.  Started having severe headaches, increased shortness of breath, blood pressure became elevated. Had to call of work and I ended up going to urgent care.
Light pain in left arm; Fever; Chills; Muscle pain all over the body; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 10:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levonorgestrel (MIRENA) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 17:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 25Apr2021 at 04:00 the patient felt light pain in left arm during the day. Then in the middle of the night pain got sharper and had fever, chills, and muscle pain all over the body, which remained for whole next day and night. The following morning  the patient had very sharp arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events light pain in left arm, fever, chills and muscle pain all over the body were ongoing at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, vomiting, severe stomach ache. Vomited from about 3:00 AM off and on until about 5:00 AM 06/09/2015. Severe intestinal pain.
Boostrix dose 4 years ago and another Booster 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received Boostrix 4 years ago).   In November 2019, the patient received Boostrix. In November 2019, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received Boostrix 4 years ago and another booster 2 years ago, earlier than the recommended interval, which led to shortening of vaccine schedule. The patient would like to take another booster, all boosters were due to grandbabies being born. The pharmacist was unable to provide date of first Boostrix. The reporter consented to follow up.
Severe soreness and quite a bit of swelling at injection site. Chills and entire body soreness starting around 10pm continuing until through the next day until about 6pm. Head pressure for about two days. Arm soreness and swelling lasted three days. Took Tylenol every four hours from 6pm 8/3/21 until 11pm 8/4/21.
Information has been received from pharmacist who learned from a nurse, concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concurrent conditions were not informed. On an unspecified date in 2016, reported as "earlier in the year, maybe 6 months ago", the patient was vaccinated with one dose of ZOSTAVAX (lot #, expiration date and therapy route were not provided). Concomitant therapies were not informed. In November of 2016, reported as "last week", the patient received a second dose of ZOSTAVAX (lot #, expiration date and therapy route were not provided). The outcome of the event was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Immediately post vaccine pt slumped to floor, had tonic clonic movement of arms and legs and was incontinent of urine - After 10 minutes she had improved somewhat but upon trying to ambulate she vomited x 2.  She was then transported to the ER by ambulance.
Crying for 3 hrs. Then on 11/14 fever 102 (lasted one day). Then on 11/19 upset stomach/diarrhea.
Developed red blisters to his torso Friday July 10, 2020 a few more have developed after the first and the first are now crusted. No fever or cough. Not bothered by the spots. Had telemed visit 7/13/20 to verify and it could be mild reaction, nothing significant.
I am having sensitive skin in my left leg. It travels from the back of the upper leg to the front of the lower leg area. I received the second vaccine yesterday 1/12/21 and I am still having the skin sensitivity. Almost as if it traveling along a nerve of vein.
T100 orally, redness, swelling & tenderness @ inject site; tx warm compresses & topical DPH w/marked improvement;
High fever; Pains; Aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Negative.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment details included paracetamol for fever.
I got the 1st dose of the pfizer vaccine on 7/29/21 and the next day I had a taste in my mouth that was like a metallic taste but I could smell ink from a pen.It was like I had pen ink in my mouth.It lasted about a week and I started getting headaches that I am still having to this day.I have to go for an mri related to the headaches next week.
Per self report: The day after receiving hep B dose #1, reported itching, red, swollen area at the injection site that was larger then a localized reaction. Symptoms lasted about 1 week. Took BENADRYL with hep B #2, no difficulties.
Patient came in on 9/29/17 w/Grandpa. She complained of itch. She had hives on legs and arm but not on injection site/ recommended BENADRYL and recommended to see her PCP.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 67-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "he has cardiomyopathy or heart disease" (ongoing), notes: Reporter said he has cardiomyopathy or heart disease.; "arrhythmia" (ongoing); "he has cardiomyopathy or heart disease" (ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious), outcome "recovered", described as "nasty for 3 or 4 days"; DECREASED APPETITE (non-serious), outcome "recovered", described as "loss of appetite"; LETHARGY (non-serious), outcome "recovered", described as "for 3 or 4 days lethargic"; INFLUENZA (non-serious), outcome "recovered", described as "he did not have a good experience with this initial series like not a good flu and kept me out of work for the whole week"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "Couldn't do much/ stayed around the house". Additional information: It was reported that the patient would be 68 in a month. The patient has cardiomyopathy, arrhythmia and was on different medications because of these conditions. The patient was little concerned because of getting more shots. It was reported that, since Comirnaty was new and not tested properly he was a little concerned with his maladies. The patient did not visit his cardiologist about the next shot. Cardiologist was adamant about him getting the first shots because of his malady. The patient was more skeptical going forward. 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-202201104406 Same patient/events, different dose;
On or before 8 days post vaccine, child developed a rash. Was seen at doctor office a week later. (12/22/21) Dx with Petechiae and bloodwork was taken. Platelets were normal. As of 12/31/21 rash is still present.
Severe swelling and pain. Took Cephalexin 500Mg 4x/day for 10days. Patient c/o pain periodically.
Erythema at injection site growing increasingly worse over the course of 2 days. It was recommended she self treat with NSAID and ice applied to affected area.
The recipient received his second dose at a 21-day interval unintentional. His first dose vaccine was administered on 4/9/2021.  Appointment Verification Personnel: Unable to pinpoint the person involved in this incident for this role.  Vaccinator:  I vaccinated the patient under the impression that the system and the front desk verified that his time was up for his 2nd dose, I have no way of checking the patient's information.   Vaccinator Scribe: I verified the patient's identity but had no way of checking his first dose information.  I assumed the system wouldn't let the patient schedule before his time frame.
I was 24 weeks pregnant at the time of receiving my first Pfizer vaccine.  I was 27 weeks pregnant when I received the second Pfizer vaccine.  My daughter was born at 37.5 weeks, weighing 7 pounds and healthy.  However, she failed her newborn hearing screen and was just diagnosed with severe to profound sensorineural hearing loss.
1st dose in 2019, never got the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's comment: Pharmacist reported that a patient never got the 2nd dose. Reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
administered PENTACEL to a patient 5 years old and 9 months with no reported adverse event; Initial information received on 07-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient 5 years old and 9 months with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.5 mL of 5th dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine (lot UJ641AAA, expiry date: 28-Feb-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  On 07-Sep-2022, (latency: same day) the patient was administered pentacel to a patient 5 years old and 9 months with no reported adverse event (product administered to patient of inappropriate age).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a patient of an unknown age and gender 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 NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Rash and swelling in approximately 4 in diameter circle near the vaccine injection  location.
PINKISH DISCHARGE AT INJECTION SITE, SWOLLEN GLANDS, HEAVY NOSE BLEED, LARGE BLOOD CLOTS
Unsure of actual onset but noticed the issue the following day and it remained for approximately a week after. There was a red circle with raised bumps around the injection site.
Patient requested pneumonia vaccine, but without verifying the paperwork she filled I gave her FLUARIX vaccine.
Pt received Her Bivalent covid 19 vaccine ( pfizer)  on 10/25/2022 Pt admitted to hospital 11/17/22  with stroke , discharged home 11/19/22
No adverse event; HCP stated they accidentally administered 1 expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 expired dose) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     Patient did not have any known medical history/conditions, allergy, concomitant diseases and risk factors.     On 09-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 09-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 expired dose).    No concomitant medications were reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Pt inadvertently received an injection of Tetramune lot 456-059 which expired in 12/1999. The reporter indicated that the child has a history of carbohydrate malabsorption and a milk allergy. The next day, the child developed an injection site reaction. She recovered. The reporter indicated that 4 pts received expired Tetramune, however, only one was identified.
Information has been received from other health professional referring to a 13 years old male patient with asthma. The patient was vaccinated with lot # (669796/0840AA) dose 1 GARDASIL, right deltoid on 22-DEC-2011 at 15:10. No other co-suspects were reported. Concomitant medications included HAVRIX (lot # AHAVB5348A, second dose administered in proximal right deltoid) and FLUZONE (lot # 441899, first dose administered in left deltoid). It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at temperature of 32 degrees F or less. No adverse reaction occurred. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Fever 99.8/chills, ibuprofen, resolved within 24 hours; Body aches/pain, ibuprofen, resolved within 24 hours; Partial Numbness in injection arm, no treatment, resolved within 6 hours; Fatigue since injection, no treatment, ongoing; Trouble falling asleep, no treatment, ongoing; Minor chest pain/discomfort during intense cardio exercise, no treatment, one time incident.
Wrong vaccine was given to patient. Immunization selection tool selected Fluarix Quad, patient's insurance was billed for FLUARIX QUAD, but FLUZONE HIGH DOSE was administered. No adverse reaction was reported by the patient.
burning itching began 2 1/2hrs p/vax;nausea & h/a began 8hrs p/vax;15hrs p/vax stiff next, painful arm muscle & lymph nodes in arm radiating down rt side lasting 2 days
Right arm was bruised, swollen, and hot. Dr told her it looks like hematoma. Pharmacist told her to take ibuprofen and out ice in it.
w/in several hr post vax pt became lethargic & febrile on afternoon p/vax;devel t105 R; very lethargic;
The day I received the 2nd dose of the COVID-19 Moderna vaccine (Sunday, October 24, 2021), I was approximately 7 weeks 3 days pregnant. Around 7 hours later and onward for 3 days after receiving the vaccine, I developed severe pelvic cramping, heavy bleeding and lower back pain. When I went for my OB and sono appointment on Friday, October 29, 2021, I was told I miscarried. I received the first dose of Moderna on Sunday, September 26, 2021, just before finding out I was pregnant on Thursday, September 29, 2021.
Narrative:  Patient was administered an expired dose of the Janssen Vaccine (expiration date 5/10/2021 @1730 and administration date 5/11/2021 @8:53). Company was contacted and it was determined that the course of action was for the patient to receive another dose of the Janssen Vaccine in the opposite arm. Patient was contacted, briefed on situation, and agreed to receive another Janssen vaccine (5/11/2021 @10:14). JPSR event was entered to review a "system-based" solution and PCP alerted.
Very serious reaction 12 minutes later; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very serious reaction 12 minutes later.   The patient's medical history was not reported. Concomitant product use was not reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, within 12 minutes of vaccine administration, the patient experienced a very serious reaction. The patient was taken to the emergency room (ER) via emergency medical services (EMS). No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, very serious reaction 12 minutes later, was not reported.; Reporter's Comments: This case concerns an female, who experienced a serious unexpected event of vaccination complication. The event occurred approximately 12 minutes after first dose of mRNA-1273, (Lot# unknown) administration. There is no information available regarding medical history and concomitant medications. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.