chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of two patients were administered expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 23-Jan-2011. The patient received the expired FLUMIST on 24-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. 04-Mar-2011: Follow up call was conducted on 03-Mar-2011, no adverse events were reported following administration of the expired FLUMIST.
dose given beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond use date) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066k21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022 at 10:30 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  No temperature excursions were reported. On 11-April-2022  at 10.30 AM was date and time vial was first punctured. It was reported that dose administered >12/24 hours post puncture. Vial was exposed to room temperature for 5 minutes.
pt recvd vax;devel discolored grayish front teeth;pharm reported that vax not MFRed by MSD;
blood clot; heart attack; This is a spontaneous report from a contactable consumer. This consumer reported for his father.   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced blood clot  and had an heart attack  on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
5-10 min /p injection, pt felt faint & nearly passed out. Pt looked pale, totally gray & BP before inject 100/60 dropped 80/50. Pulse 40-50, pt responsive through episode. Systoms resolved within 5-10 /p inject.
Admit date 08/24/21 HPI: pt presented to the ER complaining of shortness of breath; pt stated he had URI symptoms for 1 week; tested COVID negative 1 week prior; home health nurse says he is now positive for COVID; hypoxic at home, oxygenating in 70s; placed on nasal cannula; dry cough  Creatinine of 1.9; chest xray showed patchy infiltrates concerning for COVID; pt has hx of asthma Treatment plan: oxygen prn, lovenox 40 mg subq bid,  albuterol prn, Tylenol prn, dexamethasone 6 mg qd, remdesivir, normal saline 75 cc/hour Transferred to icu on 08/27 with COVID pneumonia and worsening respiratory failure with hypoxemia; started on baricitinib; intubated on 08/29/2021; sedated; prone positioning; amiodarone infusion for atrial fibrillation with rapid ventricular response; 09/02/21 hyperkalemia; Eliquis to replace lovenox; versed on 09/03; tracheostomy and PEG tube placed on 09/08/21; patient deteriorated throughout the day; received maximal pressor therapy and was noted to have decreasing heart rate; pt was dnr and passed away the afternoon of 09/09/2021
This case was reported by a physician via call center representative and described the occurrence of reflex sympathetic dystrophy in a 63-year-old male patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Concomitant products included SHINGRIX. On 30th October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reflex sympathetic dystrophy and pain. On an unknown date, the outcome of the reflex sympathetic dystrophy and pain were unknown. It was unknown if the reporter considered the reflex sympathetic dystrophy and pain to be related to SHINGRIX. Additional details were reported as follows: On 27th August 2018, the patient received 1st dose of SHINGRIX (batch number: JC92P, expiry date: 22nd November 2020) The physician reported that, the patient diagnosed with reflex sympathetic dystrophy (RSD) had experienced worsening RSD symptoms followed with completion of the SHINGRIX 2 dose series. The call center representative was listed both doses of SHINGRIX due to concern of a cumulative effect and adverse event was reported as Pain-RSD. The reporter consented to follow up. The reported lot number (EH927) for SHINGRIX did not exist and was updated to EH9Z7, according to sales datasheet.
Transverse myelitis acute rapid onset 3/22/21 with severe right lateral mid back pain, rapidly progressing lack of bilateral lower extremity sensation and rapidly progressing within hours to complete paralysis with fecal and urinary incontinence
her right arm did get swollen; This is a spontaneous report from a contactable consumer (patient). An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration, administered in right arm on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation; influenza vaccine (FLU), via an unspecified route of administration on the same date, at unspecified dose for immunisation. Patient's Medical History (including any illness at time of vaccination): None. The patient's concomitant medications were not reported. Other Products: No. The patient experienced her right arm did get swollen on an unspecified date with outcome of unknown.  About 2 years ago, she got a pneumonia booster and a flu vaccine on the same day, both in the right arm, and her right arm did get swollen. List other relevant diagnostic and confirmatory test results for event: None. Investigation Assessment: No. The patient didn't take any medications for it, but did take supplements.  Company is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Extremely large hard lump on arm near site of injection.  Appeared within 1 day
Within 1 hour, post vax, pt's upper arm became swollen and painful. Very uncomfortable to sleep on. Observed by myself 48 hours, post vax, swelling, hot to touch and visibly very sore to touch. Denies any respiratory problems. Ice and hydrocortisone cream applied. She'll continue with ice. Doctor in to check arm.
Varicella given 3/26/01. On 4/3/01, child had severe case of chickenpox (face, abdomen, trunk, legs, arms, back and hair). Took to MD on 4/3/01. Zyrtec and Aveeno baths and Aveeno lotion prescribed. Child missed 8 days of school. Is ok now. Old pox marks, evident.
Breakthrough case admission after 3 vaccines Moderna 2/24/21 lotA3 010A21a;  MOderna 3/24/21 lot# 047A21a;  Moderna 1/14/22 lot# 066h21a
No adverse event. We are just reporting we accidentally gave a Pfizer booster dose to a 13-year-old when the booster is only approved for age 16+.
at about 36 hrs post vaccine developed severe chills, fatigue, confusion. Chills lasted several hours and after warming blanket and extra blankets they went away. Severe weakness lasted most of the following day until evening. Temp. under 100 degrees all day.
Vaccination given approx 9:30 am Chills starting at approx 5:00 pm Severe body aches and fever starting at approx 8:00 pm and lasting thru the night  By 7:30 am symptoms had improved.  Took Advil and was able to resume normal daily activities
arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was sore".  Additional information: Patient stated that her arm was sore for few days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Congestion a side effect of moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jul-2021 and was forwarded to Moderna on 17-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (Congestion a side effect of moderna) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion a side effect of moderna). At the time of the report, NASAL CONGESTION (Congestion a side effect of moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning a 2-month-old male who on 31-OCT-2006 was vaccinated with a 2 mL oral dose of ROTATEQ. Approximately 24 hours after receiving the vaccine, on 31-OCT-2006, the patient experienced vomiting and had a fever of 101.8. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
dizzy, heart racing, lightheaded. Evaluated by EMS- Refusal to Transport.
Left arm was sore day several days after the administration 1/20/21 of the Covid Vaccine.  There was no redness, heat or bumpyness of the upper arm tissue.  1/28 itching started and redness in the area of where the Vaccine was given and has continued .  There are two small areas hot to touch, bumpy, a little itchy and red--one the size of a quarter and the other the size of a dime.
This spontaneous report as received from a pharmacist refers to a currently 19 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unknown date, as a child, the patient was vaccinated with "lot number reported as 0008AA, expiry date 18-DEC-2012", M-M-R II. No lot numbers, dates, dose or route were available for the vaccine doses received in childhood. In 2013 (reported as recently), the patient had a negative titer for mumps (mumps failure to seroconvert). On 15-FEB-2013, the patient was vaccinated with an expired dose of live M-M-R II (lot number 0008AA, expiry date 18-DEC-2012 not verified), 0.5 ml, subcutaneous. No adverse event was associated with the administration of the expired vaccine. The outcome of recently had a negative titer fir mumps (mumps failure to seroconvert) is unknown. It is unknown if the patient sought medical attention. Additional information has been requested.
she had COVID; she had COVID; fever; muscle aches; very weak.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "fever". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she had COVID"; PYREXIA (medically significant), outcome "unknown", described as "fever"; MYALGIA (medically significant), outcome "unknown", described as "muscle aches"; ASTHENIA (medically significant), outcome "unknown", described as "very weak.". Therapeutic measures were taken as a result of suspected covid-19, pyrexia, myalgia, asthenia with steroids and antibiotics.  Clinical course: Reporter does have vaccines she gets worse things, her sister experienced the same thing. Her sister had 2 doses of the Pfizer COVID vaccine and she had COVID and was more sick than ever. It was a miracle that her sister didn't go to the hospital.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states Left ARM weakness 2 days post vaccine. Patient went to urgent care on 1/4/20 and sent to ER on 1/4/20 For left Arm weakness and positive for Influenza
Patient had just completed administration TDaP, Typhoid and Hepatitis A. As soon as I completed those injections client and states she felt weak and "head started to spin". States started after 1st inj but could not get words out to tell me. Fan turned to Pt, cool wet compresses to face and back of neck. Head lowered between knees. Snack bar given to client and coke. States feels better yellow fever then administered.
pt devel T103.7 for 46hr; APAP would bring it down to 102 for couple hr; barely conscious most of the day
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-039838 (Patient Link).
In the evening, I began feeling weak and feverish. Through the night I had cold sweats and aches. The following day at 9:30 a.m., I passed out at work and was transported to the emergency room via ambulance. I was told I was dehydrated and had a UTI (of which I had no symptoms previously).
minor body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 14Feb2021 as dose 2, single (Lot number: EM9809) at the age of 50 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: ZOLOFT oral taken for anxiety, start date: 2003 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, Time: 12 PM, Anatomical site: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL8982), administration date: 24Jan2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "minor body aches". The following information was reported: PAIN (non-serious) with onset 14Feb2021, outcome "recovered" (15Feb2021), described as "minor body aches".  Additional information: Vaccination facility information for dose 1, Vaccination facility type: School/Student health clinic. Vaccination was not administered at Military Facility. Specific relevant test for thromboembolic events with thrombocytopenia was none. The first 2 vaccines resulted in minor body aches that lasted about 24 hours. Not serious, no medical attention was required. Lack of Effect details: No lack of effect-product reduced disease/symptoms to expected level. The patient did not experience any adverse event(s) as a consequence of the error.
three days later she got hives, but it was not as bad as the first time.; first vaccine given on 10Feb2021 second vaccination on 23SEPT2021; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (three days later she got hives, but it was not as bad as the first time.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Hives (before her first vaccination). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and HYDROXYZINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021). On 26-Sep-2021, the patient experienced URTICARIA (three days later she got hives, but it was not as bad as the first time.). On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first vaccine given on 10Feb2021 second vaccination on 23SEPT2021) had resolved. At the time of the report, URTICARIA (three days later she got hives, but it was not as bad as the first time.) outcome was unknown.            Patient took Benadryl before the second vaccine to keep the hives down.   This case was linked to MOD-2021-337927 (Patient Link).
temperature 100.4; very thirsty; excessive urination; went to the bathroom every 45 minutes to pee; urine turned dark in color \ urine looked like honey; muscle ache; This spontaneous case was reported by a patient and describes the occurrence of THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey) and MYALGIA (muscle ache). On 16-Apr-2021, the patient experienced PYREXIA (temperature 100.4). At the time of the report, THIRST (very thirsty), URINARY INCONTINENCE (excessive urination), URINE OUTPUT INCREASED (went to the bathroom every 45 minutes to pee), CHROMATURIA (urine turned dark in color \ urine looked like honey), MYALGIA (muscle ache) and PYREXIA (temperature 100.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 100.4 (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient stated that within 2 hours of stopping the water consumption, her urine turned dark in color. After she started consuming water again problem resolved itself. Action taken with mRNA-1273 in response to the event was not applicable Treatment medicines were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079248 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Added Adverse event Chromaturia; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079248:Case for first dose
Onset of high fever with chills and rigors 15 hours post RSV vaccine Arexvy. Fever with chills and rigors persisted for 3 days requiring hospitalization to rule out sepsis/recurrent pneumonia.
Received COVID vaccine at 6:30pm on 1/23/21 at Reading Hospital; Waited 15 min at hospital under nurse supervision; noticed twitching in arms and hands; 2 hours later, still twitching, mild difficulty getting full breath; 4 hours later (10:35pm) hives spread from mid arm to shoulders to neck, up behind ears and along sides of face; Took 3 Benadryl, 3 Tylenol, 1 Ativan; 30 min later (11:00pm) moderate difficulty swallowing, shakes and twitching; 30 min later, most symptoms subsided with Benadryl. Fell asleep at midnight. Woke up next day with sore arm, overall fatigue and headache.
Vaccine given at 3:15pm.  At 3:50 she c/o "feeling warm or flushed" and her back itched.  Upper back had hand sized area that was red.  B/P 120/82.  Five minutes later she vervbalized feelings of anxiety and concern over her asthma.  C/o SOB.  0.5 cc Epinephren given sub q at 4:05.  Dose repeated at 4:25 and 911 called despite protest of client.  4:30 transported to ER.
Well there were a number of symptoms: I was having stomach burning sensation from my diaphragm; heart palpitations - almost like a panic attack; dizziness - frequently. And then I passed out - I fainted out and got a concussion. So I went to the doctor and she referred me to Cardiologist for tests. I have not passed out since so they aren't putting me on medication. Treatment: Sitting up slowly; increase salt intake and increased hydration. To help with the problems with dizziness. The other symptoms are slowly resolving and the cardiologist says they should continue to resolve - she's seen this in other patients.
Confirmed Breakthrough Case   COVID-19 (Moderna) 1 80 Years 4 Months 04/14/2022 Pharmacy   Moderna   001M21A
On 12/30/09 client received H1N1 influenza vaccine at health department. Approximately 12 hours after receiving the vaccine client felt a "tingle" on her lips (as if getting a cold sore). A few hours later the nerves on her face felt irritated. The next morning, 12/31/09, client awoke with a 4 cm dry itchy patch (like eczema) beneath the right eye. The itchy patch lasted about 1 week, and then doubled in size for 3 additional days. The night of 1/14/10 the patch started filling with fluid and became the size of a large brazil nut. On 1/15/10 client went to Private Provider, who informed her it was a possible bite, abscess or herpes. Client was given intramuscular injection containing an antibiotic and steroid and a 10 day course of oral antibiotics. On 1/6/10 swelling decreases to half the size, continuing improvement until 1/18/10. Client noted feverish symptoms and an increase of fluid in the lesion under the right eye. Client returned to Dr on 1/22/10. Physician encouraged client to complete the antibiotics and she will get better. Today, 1/28/10, client continues to feel bad and feverish.