chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HCP called to report that a 7-Month-old was given a dose of VARIVAX. No symptoms reported. Permission to contact given. No further AE details/No PQC.; No symptoms reported. No further AE details/No PQC.; This spontaneous report was received from a healthcare professional regarding a 7-month-old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On 06-JUN-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5ml, once, as prophylaxis (lot number W024335 and expiration date 01-AUG-2024, both confirmed as valid) (no more vaccination details provided) (product administered to patient of inappropriate). No symptoms reported and no further adverse event (AE) details (no adverse event).
No adverse event; I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022, the patient experienced ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (I gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday.).    No concomitant information provided It was reported that hcp gave somebody 2 shots of Moderna Covid-19 Vaccine, Bivalent yesterday. Hcp gave them a dose in his left arm, then in their right arm. No treatment information provided
Elevated heart rate (137) and elevated blood pressure (176/96).  Lasted about 2 hrs. until I started to calm down and took a Xanax .25mg
Fainting took place less than one minute after receiving the vaccine and lasted about 1 minute.
patient felt like she was going to black out; slipping consciousness; nauseous; weaknesses; fatigue/fatigue in waves; fever; swollen lymph nodes; right breast sharp cramping; palpitations; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 (lot number: EN6206) at the age of 36 years old, as single dose for covid-19 immunization. Medical history included gilbert's syndrome, past lyme disease (treated), anxiety and asthma.There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9266, administration time: 02:15 PM, vaccine location: left arm, dose number: 1). Day 1 to 3 post vaccination (Mar2021), the patient experienced fatigue with fever. On day 4 to 5 the patient felt fine. On day 6 to 12 (Mar2021), the patient experienced extreme fatigue in waves, swollen lymph nodes and right breast sharp cramping, and some palpitations. On day 12 (20Mar2021 08:45), the patient had extreme wave of fatigue hit and the patient felt like she was going to black out, nauseous, weaknesses, slipping consciousness, called ambulance. It was reported as unknown if treatment was given to the patient for the adverse events. The events resulted in visit to emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines in four weeks and no other medications in two weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient recovered from fever on unspecified date in Mar2021. Outcome of the rest of the events was unknown.
No additional AEs; expired vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 24-AUG-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U008899, expiration date: 12-AUG-2023, administered intramuscularly for prophylaxis. No additional adverse events or product quality complaint reported.
10 patients given expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) 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 EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients given expired doses) outcome was unknown.        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.
The person started having right lateral chest aching about 2 days after flu shot and then sharp pleuritic type pain the next day radiating around to back.  She was started on antibiotic.  Pain gradually decreased.
Patient fully vaccinated and boosted with Pfizer on 1/8/21, 1/29/21, and 8/15/21. Patient received a kidney transplant in 2018. Presented to the ED on 11/20/21 with altered mental status and blood glucose of 700. Patient was admitted to the ICU for severe covid pneumonia. Patient was later discharged on 12/28/21
Pain within 24 hours of injection, muscles tender to touch, and a few blisters to her right shoulder. Left arm pain x 1 month.
Initial case was received on 29 June 2010 from a healthcare professional. A 17 year old male patient received on 09 June 2010 a left deltoid intramuscular injection of FLUZONE SV 2009-2010 (lot number not reported), a right deltoid intramuscular injection of TYPHIM Vi (lot number not reported), a left deltoid subcutaneous injection of YF VAX (lot number UF716AA), a right deltoid intramuscular injection of H1N1 (Manufacturer CSL-lot number not reported) and a left deltoid intramuscular injection of Hep A. On the evening of the vaccinations (09 June 2010), the patient began feeling tired and having body aches. Then 24 to 48 hours later he had yellowing of eyes, darker urine (stated as "beer brown"), loose and lighter in color stools, felt achy and not feeling well. On an unspecified date a liver function test was "greatly elevated" and titer for Hep A, B, C was negative. The patient was seen by a primary care physician (PCP) and was referred to a gastroenterologist, who after evaluation felt these symptoms were related to (R/t) the minocycline the patient had been on intermittently for 1 to 2 years. No treatment was reported. The patient had no illness at the time of the vaccinations. His medical history included acne and his concomitant medication was the minocycline. He had no adverse events following prior vaccinations. The patient had recovered on an unspecified date. Documents held by sender: None.
General tenderness in injection site day of and day after, nausea and vomiting two days following. Woke up with no pain or discomfort, but as I stood and walked I was in pain from the injection site to my stomach, then I proceeded to vomit and felt fine.
headache started at 17:45 day of vaccine stomach ache started around 18:00 then chill and uncontrollable shaking around 19:30 temperature was taken around 20:00, came to 99.8 (I typically run a little low) body aches occurred the entire time symptoms continued until 17:00 the following day
Within 5 minutes I felt post-nasal drip, then my inner left ear started feeling swollen and clogged.   Then the area from my left ear to my cheek and left side of nose felt numb.   Almost like novocaine had been injected.     After 10 minutes my chest started feeling a little tight.     After 15 minutes I left the facility and used my inhaler (I have occasional asthma) and my chest opened right up.   The numb feeling on left side of my face & ear persisted and I developed a headache around my left eye.   I was very tired that afternoon, took tyelenol and went to bed early.   Woke up and the numbness was mostly gone.
10 patients administered vaccine past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (10 patients administered vaccine past the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna Covid-19 vial that had been punctured on 04-NOV-2021 and is past the 12 hour beyond use date at time of administration. No concomitant medication were given. No treatment information were given.
neuropathy tingling sensation and aches in both feet had almost gone away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): INT-20600 (BioNTech SE).  A 78-year-old patient received BNT162b2 (BNT162B2), on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes II", start date: 1997 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; HYDROCHLOROTHIAZIDE; LOSARTAN; AMLODIPINE; METFORMIN; CARVEDILOL. Vaccination history included: Covid-19 janssen (dose 1, Lot number: 202A21A), for COVID-19 Immunization; Covid-19 janssen (dose 2 (booster), Lot number: 202A21A), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "neuropathy tingling sensation and aches in both feet had almost gone away".  Additional information: Patient has been diagnosed with diabetes II for the past twenty-five years. The neuropathy has become more and more pronounced over the years. It was a constant tingling along with aches and sometimes constriction in the toes. The soles of feet were where the tingling and aches occurred every day and continued to a lesser degree throughout the day. The patient noticed that after two-three days after the Pfizer covid vaccine booster injection (received on 07Dec2022) that the neuropathy tingling sensation and aches in both feet had almost gone away. This cessation had also occurred after the previous Pfizer COVID booster on 20Dec2021. The previous cessation gradually diminished after six months and the neuropathy symptoms returned. The patient has other health issues (not further specified).  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) : US-PFIZER INC-PV202200120946 same patient/event, different drug;
Extreme fatigue, extreme join paint, dizziness, headache, swollen lymph node in armpit of right arm, diarrhea, nausea, fever, tremors, painful vagina/clitoris  Took Extra Strength Tylenol for 2 days.  Symptoms lasted 4 days with lessening strength. As of writing this, the swollen lymph node and painful clitoris still continue.
At 6:15 PM soreness at the site, nausea, aching joints, headache: thought nothing of it and went to bed. 09/17/2016: AM all of the above plus fatigue. PM Swelling at the site, blotchy redness about 2.5" diameter, painful to touch, could not raise arm above shoulder, mild sore throat started, constipation (unusual for this patient), fever (3.5 degrees above patient's normal temperature) NB no signs of allergic reaction. Went online and decided symptoms were at the outer edge of normal. Took 400mg. ibuprofen. 09/18/2016 fever down 1.5 degrees, pain and achiness ongoing, fatigue extreme, nausea ongoing. Spent most of the day in bed. Decided to report my experience. I have never before had a bad reaction to a vaccine, and I've had a lot of them.
Herpes Outbreak (hadn't had one in more than 2 years); vaginitis; fibromyalgia symptoms exacerbated; vaginal lichen sclerosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "herpes" (unspecified if ongoing); "MCK" (unspecified if ongoing); "endometriosis" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; LATANOPROST; HYDROCHLOROTH; YUVAFEM. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 13Nov2021, when the patient was 74-year-old, for COVID-19 immunization. The following information was reported: HERPES SIMPLEX (non-serious), outcome "not recovered", described as "Herpes Outbreak (hadn't had one in more than 2 years)"; VAGINAL INFECTION (non-serious), outcome "not recovered", described as "vaginitis"; FIBROMYALGIA (non-serious), outcome "not recovered", described as "fibromyalgia symptoms exacerbated"; LICHEN SCLEROSUS (non-serious), outcome "not recovered", described as "vaginal lichen sclerosis". The events "herpes outbreak (hadn't had one in more than 2 years)", "vaginitis", "fibromyalgia symptoms exacerbated" and "vaginal lichen sclerosis" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes simplex, vaginal infection, fibromyalgia, lichen sclerosus (Vagifem; clobetasol; acyclovir; antibiotics).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
numbness in left arm, through left breast and armpits; numbness and tingling lasted for four hours; more she used her arm,the more numbness she experienced; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left arm, through left breast and armpits), PARAESTHESIA (numbness and tingling lasted for four hours) and HYPOAESTHESIA (more she used her arm,the more numbness she experienced) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L70A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in left arm, through left breast and armpits), PARAESTHESIA (numbness and tingling lasted for four hours) and HYPOAESTHESIA (more she used her arm,the more numbness she experienced). On 13-Feb-2021, HYPOAESTHESIA (numbness in left arm, through left breast and armpits), PARAESTHESIA (numbness and tingling lasted for four hours) and HYPOAESTHESIA (more she used her arm,the more numbness she experienced) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-015162 (Patient Link).
flu like symptoms. No temperature.  chills, hot, tired,  2 days, still going.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX (batch number 5223C, expiry date 28th April 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: Between 3:40 pm to 5:00 pm, the patient received SHINGRIX on left arm. On 22 April 2018, the patient went to the pharmacy sometime after noon and showed that he had a red, palm-sized area at the injection site.
Immediately after vaccine administration, patient lost consciousness and postured in decerebratic position for about 30 seconds and then woke and felt "out of it" for about 1 minute.  Paramedics arrived and patient evaluated and patient monitored for about 20 minutes.  Monitored by RN for additional 20 minutes.
I had SOB, nausea, diarrhea, fatigue, serve cough, body aches that lasted for 2 weeks. On Nov 2nd, I tested positive for COVID-19. I went to urgent care about this. I also got the antibody injection. I also have hair loss.
This spontaneous report was received from a Medical Assistant regarding unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with unknown number of doses of ROTATEQ (lot # L039141 with expiry date 16-AUG-2016; lot# M004883 with expiry date 02-OCT-2017; lot# M025568 with expiry date 07-NOV-2016 and dosing details not known) that were improperly stored. The administered doses experienced a temperature excursion of 32.1 F(Fahrenheit) for 5 hours 10 minutes and 51.6 F(Fahrenheit) for 1 hour 4 minutes. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information is not expected as the reporter denied consent to be contacted for further information.
Information has been received via telephone call from a doctor of pharmacy concerning a 25 years old female patient, who on 11-NOV-2010 was vaccinated with a dose PNEUMOVAX (Lot "not reported). The pharmacist reported that the patient experienced soreness, redness, swelling, and a "burning pain" in her upper arms, low grade fever and chills. The patient was not feeling any better on unspecified antibiotics, in fact was feeling worse. This one of three reports from the same source. Additional information is not expected.
Dull headache x 3 days. Starting Saturday night 10/22/16. Had flu vaccine around 2:20 pm. C/O itchy rash to the torso and right arm three days after flu shot.
Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D), for an unknown indication from an unknown date and unknown if ongoing. On 04Mar2021, the patient experienced arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events arm soreness was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.