chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of expired FLUMIST administered was received from a pharmacist concerning a female child. No medical history was provided for the child. The patient was inadvertently given FLUMIST that had expired four days prior. There was no adverse event associated with this medication error: therefore treatment and causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of two years to 59 months of age for FLUMIST.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Temperature excursion; This spontaneous report has been received from licensed practical nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 02-NOV-2020,  the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) formulation not reported but defaulted to subcutaneous injection, 0.5 milliliter, Lot # reported as T016147, expiration date 07-NOV-2021 for prophylaxis (dosage regimen and patient route of administration were not reported).   The temperature was reported to had been at -13.9°Celsius (°C) to -14.7°C . For 30 minutes, the temperature was in between -14°C to -10°C (-13.9°C). For 15 minutes, the temperature was in between -14°C to -10°C (-14.2°C). For 20 minutes, the temperature was in between -14°C to -10°C (-14.7°C). For 5 minutes, the temperature was in between -14°C to -10°C (-14.6°C).There was digital data logger involved.   Lot # T016147 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 07-NOV-2021, but upon internal validation established as 11-JUL-2021.
Information has been received from a physician concerning a 13-month-old male with no pertinent medical history who on 05-APR-2007 was vaccinated with a dose of ProQuad. There were no concomitant therapies. On 19-APR-2007 the patient experienced a generalized varicella rash. The rash was not localized around the injection site, but rather generalized at the trunk and leg. One vesicle developed into a methycillin-resistant staphylococcus aureus (MRSA) (onset-23-APR-2007). The patient was seen daily by the physician at the office from 20-APR-2007 to 23-APR-2007 for cellulitis at one of his legs. On 23-APR-2007, the patient was admitted to the hospital for cellulitis, and was treated with several courses of antibiotics. He had an incision and the doctors drained about 15cc of fluid from the thigh. The outcome was reported as not recovered. There was no product quality complaint. The event were considered to be other important medical events by the reporter. Additional information has been requested.
Information has been received from a physician concerning a 9 year old female who on 21-APR-1999 was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck). On 13-May-2007, the patient experienced a bad breakthrough case of herpes zoster around C2-C4. The patient was treated with a dose of Bactroban in combination therapy with a dose of Zovirax. At the time of the report the patient's status was recovered. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
10/8/99 tingly feeling arms & legs-severe h/a 3PM took fiorinal;10/9/99 tingly feeling cont some aching between shoulders & neck;10/10/99 hurting across shoulders & back & neck, wrists & ankles;tingly feeling cont;weak;vomited;queasiness;
Patient received Hep B that was not needed.  Patient waited 15 min, no s/s of distress noted. Will follow up with patient in a few days.
Arm pain but significantly less arm pain than the first shot. I also have a fever and I feel tired.
Vaccine taken 5pm 4/21/2020 - woke up about 7am 4/22/2020 with bad shivers and increasing temperature with lots of body ache.  This lasted for 3 days, and the following 2 days with upset stomach and diarrhea.
pt c/o mosquito bite type of rash on abd & chest from the time woke up the morning p/vax;pt states sl raised, red, & not itchy;
High fever up to 107 degree. Went to emergency service on 11/21/2014 and 11/24/2014.
This spontaneous report as received from a health care worker refers to an unspecified numbers of patients of unknown demographics. On an unknown date an unspecified number of patients may have received PNEUMOVAX 23. The PNEUMOVAX 23 was exposed to 47 F for 4 hours. No adverse effects were reported. No PQC was filed. The case is linked to 1405USA011937, 1405USA011938 and 1405USA009508 (same reporter link). Additional information has been requested.
As MA pulling out needle from Right deltoid, patient exhibited jerky movements, head tilted back, eyes open, no loss of consciousness, became pale, complained of nausea, vomited.
I received the COVID 19 vaccine on 12/28/21. I breast feed my daughter. She started to get a couple hives within 24 hours and then worsen  until the rash was all over her body. She became fussy and stopped wanting to nurse and a started having dry diapers so I took her to the ER on 12/31/21 related to this. ER recommended Tylenol  and were unsure of what caused the rash and said it could be cradle cap. And we were discharged home. Thankfully over the next 24 hours her rash and fussiness resolved without any intervention. I met with her Pediatrician  1/13/22 and showed him pictures of her rash. He said it was either an allergic reaction to something or a viral rash.
Extreme fatigue, tiredness, weakness (slept through the evening, night, and all day the next day; again two and three days later).
About 8pm I started having muscle aches and an headache. At 2am I woke up I had chills, 6am woke up I had a fever of 99.6 along with chills and weakness. Went to the screening clinic at 11am for COVID 19 test. Went back home and MD asked her to purchase pulse ox to monitor myself for shortness of breath. Went back to bed. By 230-3pm 24 hours later after the shot I was about 90% recovered and fever 3wqas gone.
chills  body aches, headache, site pain, muscle pain fever  2 peaks 1:00pm   1/12/2021 100"  took tylenol second peak 9:00 pm  1/12/2021  9:00 pm  101.5" took tylenol arrested and soon back to normal  11:30pm next morning almost normal, every so slight headache different location than day before
Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component in the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer in four weeks after the failed vaccine administration. Patient and prescriber office was contacted to have the vaccine done on February 6th.
?COVID Arm? - 10 days after vaccination, a large red welt appeared at the injection site. It is hot to the touch and raised. It is not itchy or painful; just hot and slightly swollen.
COVID-19; COVID-19; MARKETING PROGRAM NAME IS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single and intramuscular, administration date 23Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for Moderate To Severe Hidradenitis Suppurativa. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the (DRUG INEFFECTIVE, COVID-19 ) with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
developed a red itchy rash on my wrist (on the arm which received the injection); developed a red itchy rash on my wrist (on the arm which received the injection); This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 12Mar2021 at 08:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included terbinafine (MANUFACTURER UNKNOWN) and fluconazole (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. 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 13Mar2021 at 08:00, after the first dose, the patient developed a red itchy rash on the wrist (on the arm which received the injection). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event red itchy rash on the wrist (on the arm which received the injection) was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 09Apr2021 at 08:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Began 24 hours, post vax, on knees and spread. Dx'd as urticaria. 48 hours, post vax, top lip began to swell. Rash continued to spread. On Friday, 72 hours post vax, redness faded and left a bluish area. Grandmother reported that child's ear canal swelled Friday night and after that she started to improve.
Patient was inadvertently given Pfizer as a second dose in her COVID-19 vaccination series instead of Moderna.  No adverse reaction has been reported at the time of this submission.
positive for COVID-19; unwell; fever; chills; body ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). On 31-Mar-2021, the patient experienced COVID-19 (positive for COVID-19) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to COVID-19. At the time of the report, COVID-19 (positive for COVID-19), MALAISE (unwell), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with Ibuprofen, Nyquil and Dayquil for the symptoms. Patient was discharged the next day. Patient was treated with antibiotics for pneumonia.  Company comment: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.  Malaise is assessed as a symptom of the infection and also assessed as unlikely.  Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded.   This case was linked to MOD21-079024 (Linked Report).; Sender's Comments: Based on the information provided including the established profile for mRNA-1273, a causal association between the event of COVID-19 and the product administration is assessed as unlikely.  Malaise is assessed as a symptom of the infection and also assessed as unlikely.  Chills, pyrexia and myalgia, although also considered as symptoms of Covid-19, are temporarily associated with the product administration and consistent with the product safety profile and thus , causality cannot be excluded. MOD21-079024:cross linked
High fever, extreme shaking and chills, nausea. I was pretty much immobile from 11pm-3am (until I was able to fall asleep) on the day of vaccination (3/8/21). This happened immediately after I showered with hot water. The next day  (3/9/21) until around 8pm I had a high fever, chills (not as bad but still pretty bad), headache, nausea, fatigue, and extreme muscle/joint pain particularly in my back and arms. I was unable to work, go to school, or do homework the entire day. After 8pm, I was down to a 100.4 fever and slight chills with mild nausea and fatigue. Today (3/10/21), I have mild muscle pain in my back and near the injection site. I took 400mg of ibuprofen every 6-8 hours from 3:00pm 3/8/21 (day of injection) to present with mild effects on pain and fever levels. I?m an infrequent user of ibuprofen. If I didn?t have someone with me the first night after the vaccination (3/8/21) I would have gone to the hospital.
seizures/ having seizures since the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures/ having seizures since the vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizure (Patient hadn't had any seizures since 6 months).    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 SEIZURE (seizures/ having seizures since the vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures/ having seizures since the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported No treatment medications provided  At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained.   Reporter did not allow further contact; Sender's Comments: At this time, very limited information has been provided on this event, the start and end date, and the patient's vaccination date was not documented. Consent for safety to contact the patient was not obtained.
BACK OF RIGHT LEG IS REALLY HOT (IT COMES AND GOES); This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced back of right leg is really hot (it comes and goes). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back of right leg is really hot (it comes and goes). This report was non-serious.
Pt started to feel itchiness on the upper body. Pt cx of feeling thirsty and had a drink of water before I was informed. Pt also cx of HA. We asked pt to wait for some more to observe her symptoms. Pt declined ambulance service said she did not want to go to ER. If later on she needs it, her family will take her. Pt wanted to go home to rest.
This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of PREVNAR 13 (lot number and expiration date: unknown) intramuscular in the left deltoid on 08Feb2018 12:30 at a single dose for immunization (doctor suggested this because of her age). The patient medical history was not reported. The patient stated that she has some medical conditions, but nothing she feels is relevant and declined to provide more details. There were no concomitant medications. No vaccines were administered in the last 4 weeks. The patient previously received a tetanus vaccine shot and was allergic to tetanus. It was reported that when she was 3 years old she had a reaction to what her mother thought was a tetanus shot and she had to be hospitalized (she thinks it was a DTP vaccine). The patient received a shot on Thursday, 08Feb2018, she had a horrific experience with it. She couldn't move her left arm for 3 days and she was all swollen. She broke out in a rash from shoulder to elbow and around her arm. She took pictures of it. It was extremely painful. It was also itchy where she received the injection. She talked to her doctor and he told her to go to the emergency room. She didn't want to so she talked to a nurse and talked to their doctor line. They gave her some good advice and she had to take it easy over the weekend. On 11Feb2018, she had a knot in her left arm where she received the shot. On an unspecified date, it still hurt when she moves her arm. The swelling had gone down, but the pain and the knot in her shoulder had not. The events did not require a visit to the emergency room or physician office. She did not want to go to the doctor's office because they were going to charge her for it and she felt it was all their fault. She asked if the delivery system of this shot is a diphtheria serum because she read that it is. She has had it on her medical chart since she was 3 years old that she is allergic to tetanus. She asked if this was the same shot and if PREVNAR 13 has diphtheria in it. She was very upset with her doctor because they have known about her allergies all along. She stated that this was her first time ever receiving the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) vaccine. She had one in October that was the first vaccine of the series, but it had a different name and she could not remember the name of it. She did not have a reaction to that vaccine. Outcome of could not move her left arm was resolved with sequelae; the patient had recovered with lasting effects from not being able to move her arm. The event of left arm swollen was resolved on 13Feb2018. It still hurts when she moves her arm and she has a knot in her arm at the injection site. The itchiness described by the caller was persisting, but it comes and goes. The knot in her left arm, itchy where she received the injection and still hurts when she moves her arm were not recovered while the rash was recovering. The patient denied any medical testing. Information on batch and lot number has been requested.
Headache and dizziness that occurred about 10 minutes after vaccination as well as strange feeling in chest that came and went throughout evening of vaccination but felt like it was gone by the next morning. The next morning symptoms of headache continued and dizziness occurred on and off. Then fever, chills, body aches and joint pain occurred until midday the next day. The morning after vaccination arm pain was present and redness, warmth and pain at the site got bigger throughout the day and lasted for 4 days.
No symptoms reported but MD confirmed on 10/2/15 that pt has been hospitalized at hosp.
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (wife), of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Caller reported on Feb 16, 2021, his wife got either a spider or bat bite or something and needed a rabies shot. Caller needed to know if she can get the rabies shot or not. The clinical outcome of the event: unknown. Follow-up attempts completed. No further information expected.
went to ER since I could not bring fever down; sore throat; swollen; swollen tonsils; she was in bed for few days; it was red; it was hurting; chills; fever ranging from 100 to 104.1; soreness from her left elbow to her left ear; chest tightness; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), EMERGENCY CARE (went to ER since I could not bring fever down), OROPHARYNGEAL PAIN (sore throat) and SWELLING (swollen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Coronary artery disease.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), OROPHARYNGEAL PAIN (sore throat), SWELLING (swollen), TONSILLAR HYPERTROPHY (swollen tonsils), MALAISE (she was in bed for few days), ERYTHEMA (it was red), PAIN (it was hurting), CHILLS (chills) and PYREXIA (fever ranging from 100 to 104.1). On 25-Mar-2021, the patient experienced EMERGENCY CARE (went to ER since I could not bring fever down). At the time of the report, PAIN (soreness from her left elbow to her left ear), CHEST DISCOMFORT (chest tightness), EMERGENCY CARE (went to ER since I could not bring fever down), OROPHARYNGEAL PAIN (sore throat), SWELLING (swollen), TONSILLAR HYPERTROPHY (swollen tonsils), MALAISE (she was in bed for few days), ERYTHEMA (it was red), PAIN (it was hurting), CHILLS (chills) and PYREXIA (fever ranging from 100 to 104.1) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment was reported for the events.