chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, myalgias. Strong, rapid onset over 15 minutes. Chills resolved spontaneously overnight (6 hours). Myalgias persisted 36 hours. Myalgias resolved spontaneously after the next night sleep.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 09-JUN-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 02-JAN-2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a 35-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are
Patient received the full dose instead of the booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 040A2H and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (stage 3 leukemia Col stage 0). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster). On 12-Nov-2021, ACCIDENTAL OVERDOSE (Patient received the full dose instead of the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported. Patient reports she goes to an oncologist and it is just being watched and no treatment.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-NOV-2021 Updated Medical history Stage. On 18-Nov-2021: Follow-up received on 19-NOV-2021 Updated Email address
pleuritis that resolved over 7 days p/taking Indocin; sx onset w/12 hrs of vax; localized tenderness @ inject site that resolved spontaneously in 3 days;
16 days p/vax had a sx that lasted 18 mins; pt was taken to ER & adm for 3 days; all test done came back neg;
On 07/31/00, this patient had 50 mm erythematous, edematous at the injection site. Slight induration, (+) heat. For induration advised to apply Triamcinalone cream. On 08/02/00, the patient had fever, chills; the PCP gave Cefadroxil. On 08/04/00, advised to apply ice for 10-15 minutes to 40 mm induration. On 08/07/00, resolving, induration down to 15 - 20 mm.
Starting at 8 pm on 1/12/21 she began experiencing chills, headache, fever, muscle pain, injection site pain. The symptoms continued until 9 am on 1/14/21 and have now completely resolve. T Max was 102.4 (tympanic).
I had headaches, chills (finger tips especially) and rapid heart beat. I began feeling winded going up and down stairs and/or walking. After a couple of more days, I began using an oximeter to check my pulse. The readings were 108 - 112 compared to my normal 60 - 82.
Patient came into the pharmacy over a month and a half later complaining that she still had a bruise and her arm still hurt in the area she had received the vaccination.
Employee states after receiving Hep B vaccine, each time would experience a metallic taste in mouth. Shortly after that would resolve 2-3 hours and joint pain that would resolve 2-3 days after starting.
only liquid portion administered; only liquid portion administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA689A, expiry date 31st October 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that only liquid portion of Menveo was administered to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2022039261, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039261:Same reporter
About 28 hours post dose 2 headache; Fever chills; Malaise; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the right arm on 25Mar2021 at 12:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El3248) via an unspecified route of administration in the right arm on 04Mar2021 at 12:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 16:00, about 28 hours post second dose of vaccination the patient experienced headache, fever chills and malaise. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL. The clinical outcome of the event headache, fever chills and malaise were recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Inadvertently administered an expired dose to a patient; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number FE272, expiry date 18th February 2022) for prophylaxis.   On 22nd March 2022, the patient received Shingrix. On 22nd March 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported they inadvertently administered an expired Shingrix dose to a patient which led to expired vaccine used. The pharmacist asked if the patient need to be revaccinated. The pharmacist unable to provide patient details. The reporter did not consent to follow-up.
redness, induration, pain & itching @ site of vax;fever 103, chills, sweats;
headache started at 4pm. But 10 pm couldn't bare the pain of headache. felt like i could feel each vein of blood pumping through my head. started throwing up. could barely get in car. Husband drove me to the ER. Had to be put in wheel chair.
Menstrual Period duration was extended from 5 days to 9 days in month of July, and spotting in between periods lasted for 11 weeks starting June 19th to September 1st. Second dose of COVID vaccine was received on June 3rd.
PATIENT STARTED DEVELOPING A RASH AND HIVES AFTER RECEIVING THE SHOT. IT BECAME NOTICEABLE ON 9/29/16. SHE THOUGHT IT WAS GETTING WORSE SO SHE WENT TO THE EMERGENCY ROOM.
The infant was inadvertently given 2 doses of Prevnar (instead of 1 dose of HIB and 1 dose of Prevnar). She had a slight "fever" that night, otherwise, no problems. This occurred because the vials for these 2 Wyeth-Lederle products both have the same color of dark blue cap.
I had a lot of pain during the injection (I am thinking they accidentally hit a nerve, I had some really strange twitches in my arm that I received the shot for a couple of days but that has mostly gone away after 2 days). After 15 min, I headed to work, and on my way - 30 minutes after the vaccine, I started to feel very hot, my face turned dark red and I started having severe itchiness that started on my face and then went to my arms, scalp, and legs. I then noticed hives on my neck and chest. I called the Pharmacy who directed me to report the symptoms and take Benedryl. The symptoms started to go away about 15 min after the Benedryl and never came back, I never had any swelling or difficulty breathing.
Information has been received from a pharmacist and a registered nurse concerning a retired 56 year old caucasian male with an allergy to codeine who on 01/21/2005 at 08:30AM was vaccinated intramuscularly in the right arm with the first dose of pneumococcal 23v polysaccharide vaccine.  Vaccination given on that same day included:  influenza virus split virion 3v vaccine inactivated given subcutaneously.  Concomitant medication included Celebrex 200mg daily.  There was no illness at the time of vaccination.  On 01/21/2005 at 16:30PM, the patient called the office to state that his arm was red, swollen and painful.  He was also short of breath and had a headache and fever.  As of 01/24/2005, his arm was still red, swollen and painful.  He was not short of breath, but was not feeling well.  It was reported that he recovered as of 01/26/2005.  Follow up information reported that the patient's left arm where injection was given was swollen, red, and very painful.  There was no diagnostic or laboratory tests performed.  No further information is available.
arm started hurting him and it's still hurting him; painful under certain conditions; cannot scratch his back or do other certain things because the arm hurts for minutes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes) 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. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes). At the time of the report, PAIN IN EXTREMITY (arm started hurting him and it's still hurting him), PAIN (painful under certain conditions) and LIMB DISCOMFORT (cannot scratch his back or do other certain things because the arm hurts for minutes) had not resolved. 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.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Dizzy, nausea, headache, mucus in nose and throat, equilibrium was off.
Injection site redness, swelling and pain; headache; feel hot, but no temperature; general malaise.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, 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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) 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 EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No concomitant medications were reported. Patient was over 18 years of age. Staff gave patients vaccines past the use date of 18 Jun 2023. On 22-Jun-2023, 5 doses were administered at administration site 2. Treatment medications were not reported.  This case is for 27th patient out of 47 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow up received: Vaccine administration date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Fever, headache, flu-like aches and pains--joint pain, miscellaneous stabbing/throbbing pains, nausea, loss of appetite
Medical assistant vaccinated this patient on there 21 day when it should have been on there 28th day for there 2nd dose of Moderna.
mild reactions; eyes burn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid 19", start date: 2020 (unspecified if ongoing), notes: developed covid 19 infection at age 17 in jan or feb2020. There were no concomitant medications. The following information was reported: ADVERSE DRUG REACTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "mild reactions"; EYE IRRITATION (non-serious) with onset 2021, outcome "recovered" (2021), described as "eyes burn". The patient was fine after the first dose of steroids. Therapeutic measures were taken as a result of adverse drug reaction, eye irritation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
several patients received their second dose but still tested positive for COVID-19 afterwards; 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 SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards). At the time of the report, SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075168 (Patient Link).
Patient said her arm started to hurt a couple days after the vaccination. Then her arm swelled up and was itching. This progressed through the week. She then stated that she had bad stiffness in her neck and shoulders.  So on Sunday, October 7th she went to Urgent Care.  They put her on oral Benadryl and Hydrocortisone cream and Tylenol.  They told her it was a localized reaction not a systemic reaction.
Patient called this clinic after hours , stated was in extreme pain was unable to move her arm well, no redness or swelling noted per patient, patient stated she went to the ER , they gave her Tordal injection for the pain, patient was not admitted, was released home, this morning this nurse called patient when message was received , was given the information above, informed patient she needs to follow up today in clinic to be seen
Information has been received on 11-DEC-2018 from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician/MD for shingles. The patient was diagnosed with shingles and or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (not further specified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
On 12/15/ 2022 I started feeling as if I had a cold. I had nasal and head congestion; constant runny nose;fatigue. Tested positive on 12/19/2022 I had a telehealth visit and was prescribed a course of Paxlovid.
Right upper arm red, swollen, tender to touch, redness under arm. fever for 24 hours. received injection on Wednesday. became red wednesday afternoon, fever during the night, increase in redness over next day. in clinic to be seen on Friday.
right after injection given Patient tells me " I am going to faint" and she did faint into my arms without any injury while sitting upright . I lowered  her down to exam table and called for help placing her feet / legs up and she came around right away. When appropriate was able to sit up again and was able to drink a beverage then was guided to sit in a chair and stayed for 15 minutes and then was released to Home when feeling completely well per Patient self report.
Pt contacted the pharmacy on 12/18/13 and stated that she had redness at the site of injection and that her arm has a raised swollen area of 1&1/2 inches. Spoke to the pt on 12/19/13 and she says the arm is about the same. She thinks taking Benadryl and using aloe on the site has helped some. At this time she did not think she needed to contact the doctor but if it started to get worse she would call the doctor.
cold; mucus; UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received PF-06928316 (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: also have COPD but breathing okay. The patient's concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION BACTERIAL (non-serious) with onset 2023, outcome "unknown", described as "UTI"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "mucus". Therapeutic measures were taken as a result of urinary tract infection bacterial.  Additional information: Patient had the RSV vaccine 3 days ago (unknown date) and had UTI at the same time and patient was on Keflex. Patient had symptoms of Cold that be reaction to shot. Patient had a lot of mucus and was sorry that he/she took the shot.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Left thigh swollen 3-4 cm x 5 cm with erythmic base 3 cm by 2 cum, warm to touch induration temp 99.4 (tylenol was gfiven prior appt), child irritable, Augmentin prescribed.