chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial sat out in room temperature for more than 24 hours and were not discarded as they should have been.  They inadvertently administered the expired vaccine to two patients\Vial was punctured 22 times; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F51A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Pharmacist stated that two Moderna vials were taken out of their refrigerator 30-Nov-2021 at 9:00 am and punctured. The vials sat out in room temperature for more than 24 hours and were not discarded as they should have been. They inadvertently administered the expired vaccine to two patients on 02-Dec-2021 at 9:30 am. He also stated vial was punctured 22 times. The vials impacted have been discarded. Date the vial was initially stored in the refrigerator was on 29-Nov-2021. The total amount of time the vial was exposed to room temperature over 24 hours.   This case was linked to US-MODERNATX, INC.-MOD-2021-404089 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes on 22-Dec-2021, Follow-up received on 22-Dec-2021 contains significant information, patient demographic details (race and ethnicity), and suspect details (dose and anatomical location) added. US-MODERNATX, INC.-MOD-2021-404089, Same reporter.
This spontaneous report was received from a nurse refers to a 4 month old female child. On 09-DEC-2013, the patient was mistakenly vaccinated with a dose of VARIVAX, oral (dose and frequency unspecified) (Lot # J006356) instead of ROTARIX. Nurse stated that her colleague diluted VARIVAX (Merck) with the ROTARIX diluent and administered VARIVAX orally to the child. No adverse effects reported at this time. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2021 at 13:15 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriasis" (unspecified if ongoing), notes: Other medical history: psoriasis. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has had severe headache with dizziness for the past 36 hours. She has tried ibuprofen and states it is not helping with the symptoms. Patient did have fever for the first 24 hours. It has resolved. She has some fatigue and muscle soreness as well 38 hours post-injection. Patient is going to try Acetaminophen to help with symptoms as well.
Extremely hot; High fever; Chills; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Extremely hot), PYREXIA (High fever), CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 FEELING HOT (Extremely hot), PYREXIA (High fever), CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site). At the time of the report, FEELING HOT (Extremely hot) and PYREXIA (High fever) was resolving and CHILLS (Chills) and INJECTION SITE PAIN (sore arm at injection site) had not resolved.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-049747 (Patient Link).
Neuropathy; Hands and feet's severe pain; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EN6198, Expiration Date: Jun2021) at the age of 62 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot number: EL3249, Anatomical location: Arm), administration date: 18Jan2021, for COVID-19 immunisation. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hands and feet's severe pain". The events "neuropathy" and "hands and feet's severe pain" required physician office visit. Clinical course: Patient's wife reported that neither one of them have taken any prescription drug ever. Patient received shot in arm. Her husband's hands and feet's had severe pain. Went to the Dr. (name withheld) at urgent care in (city, state withheld) and diagnosed neuropathy and prescribed gabapentin. Her husband was not a diabetic and did not had any other problems. Her husband refused to take any medication or Shale oil.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300228069 same reporter/drug, different patient/events;
Fever (starting 12 hours later and lasting 8 hours) body aches (starting 12 hours later and lasting 24 hours), headache (starting ~8 hours later and lasting ~30 hours), pain at injection site (starting ~3 hours later, lasting 48 hours)
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe
Information has been received from a Nurse Practioner (N.P) concerning a 49 year old female patient with sulfonamide allergy who on 13-MAR-2008 was vaccinated into right deltoid with a first dose of RECOMBIVAX HB (lot # 656876/0874U).  Concomitant therapy included DEPAKOTE.  The reporter reported that patient developed arthalgia in right shoulder after she received the first injection.  The patient continued to have arthalgia one month first injection.  The second injection was not given.  The nurse practioner also reported that patient had myalgia in addition to arthralgia.  The patient called and stated that she had this adverse event for "the last six weeks".  She explained that if she kept her arm stationary, the pain she felt "like a tooth ache".  She needed to move her arm to relieve the apin.  She reported that the pain had decreased.  The event made it painful for her to lie down and to sit still.  She felt pain when she got dressed and performed tasks required for her landscaping job.  Her pain had not decreased when she did her activities.  She had full movements of her arm but pain made some movements prohibitive.  The patient had not recovered.  Additional information has been requested.
Pt recvd flu vax on 24OCT91 & presented to ER on 3NOV91 w/ a 4 day hx of fever, lower extremity weakness; generalized weakness & questionable seizure activity;
Right arm was a little bit sore; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Right arm was a little bit sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Reflux gastritis. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure high, OMEPRAZOLE for Reflux gastritis.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was a little bit sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm was a little bit sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning a 14 year old female who on 22-JUN-2008 was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL vaccine (yeast) (lot #658554/0928U). On 22-JUN-2008, the same office visit, the patient also received varicella virus vaccine live (Oka/Merck) in her right arm. On 22-JUN-2008, "30 minutes after leaving office", the patient experienced "shooting pain down her left arm down to her left calf all the way to her big toe". The patient called the physician and was advised to rest. At the time of the report, no outcome was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2008. Follow up information was received from the physician reported that the patient with mild alopecia and attention deficit/hyperactivity disorder (ADHD) (not on medications at the time of vaccination) who on 22-JUL-2008 at 1:00 PM was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot #658554/0928U) in her left arm. On 22-JUN-2008, the same office visit, the patient also received her second dose of VARIVAX (Merck) (lot#661336/0524X) subcutaneously in her right arm. On 22-JUL-2008 at 1:00 PM, immediately after the vaccination, the patient had shooting pain in left arm. Within an hour, the patient complained pain in both legs that felt liked pressure pain was becoming shooting pain into lower leg and foot. The patient had some dizziness and no fainting. No relevant diagnostic and laboratory tests were performed. The patient was told to rest and was given ibuprofen. Pain resolved within 2-3 hours. Additional information is not expected.
A pressure/low burning sensation down the lateral rear side of my left leg. I have not felt this pain sensation there so intensely since before my back operation in October 2018. The intense sensation lasted from Sunday 07 FEB through Tuesday 09 FEB 2021, when it started to slowly wane. The inoculation site also had minimal pain. Emailed my PCP and my orthopedic surgeon.
The patient has swollen arms redness that spread from one certain area to the other, itching and pain almost next to the elbow is having the redness and purple area.
Pt. states that after receiving the 3rd Booster of Moderna 11/03/2021, started experiencing symptoms of dizziness, headache, body aches, and slight nausea. No noted Primary visit/communications. Symptoms have subsided.
Mild sore throat; Ear Pain; Headache; Tested Positive for COVID19; Fatigue; Injection site soreness; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), HEADACHE (Headache) and OROPHARYNGEAL PAIN (Mild sore throat) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness) and VACCINATION SITE ERYTHEMA (Injection site redness). On 23-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19). On 24-Jan-2021, the patient experienced HEADACHE (Headache). On 26-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Mild sore throat) and EAR PAIN (Ear Pain). On 26-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE ERYTHEMA (Injection site redness), OROPHARYNGEAL PAIN (Mild sore throat), EAR PAIN (Ear Pain) and SARS-COV-2 TEST POSITIVE (Tested Positive for COVID19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My whole family received the bivalent booster shot (Moderna and Pfizer) on 11/7 and we all tested positive for COVID on 11/9 or 11/10.  About 5 hours after the shot, I started not feeling well with a headache and wanted to lie down.  I coughed during the night, had some chills, aches, and did not want to get out of bed on 11/8.  I didn't get up until about 11am on 11/8 and went to sleep that night (11/8) at 7pm in which I coughed and I the same symptoms.  I also had a blood pressure of about 160/110 and heart rate of about 105, over several readings throughout the night of 11/8 - 11/9. The headache remained consistent and pretty strong for several days, and my eyes have been burning red.  I had tested for covid at home on 11/7 and 11/8 and was negative.  On 11/9, I saw a healthcare provider who gave me a pcr test. Later that day, I took another at home antigen test, and it was positive for COVID.  Two other family members were also positive, and the final family member was positive via a pcr test on 11/10.  We all have similar symptoms.  My husband and I both have had burning red eyes.
Can´t lift it up, can´t move hand; Extreme soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Extreme soreness in her arm). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can´t lift it up, can´t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes cholesterol and blood pressure medication.  Treatment information includes: Put ice, Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1/4 - Tylanol  at night arm was achy and mild swollen  1/5 Ice 1/6 - achyness started to resolve but injection site started to get firm and itchy . Took Tylano again and ice  1/6-1/13 no change  1/12 contacted hospital nurse who recommended OTC Hydrocortizon  1/13 applied hydrocortizon cream at night 1/14 itchyness slightly resovling and injection site still mild swollen
Pt recvd DTP/HIB/OPV on 26MAR92 & presented to ED w/1 day hx of fever & 101-15 sec episode of arm & leg twitching; several 30 sec arm & leg twitching episodes early on 27MAR92;
there was no adverse reactions; improperly stored administered ROTATEQ; This spontaneous report as received from a clinical medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # was 1684163, expiration date was 26-JUN-2021, strength and dose was not reported) orally for prophylaxis (product storage error). Temperature excursion of this vaccine was 0.92 degrees Celsius to 13.36 degrees Celsius for 43 hours and 45 minutes without any previous temperature excursion. No digital data logger was involved. The reporter stated that the patient did great and no adverse reactions had been reported from the parents since the vaccine was given.
Vaccine given 11:01 3-9-2019. At approx. 10 pm of 3-9-2019, started with all over body aches and general malaise. Took Ibuprofen, relaxed awhile and went to bed. Slept until 7:30 a.m. 3/10/2019 (unusual for me). Got up feeling weak, took shower and attempted to get dressed for church, all the while feeling worse with nausea starting (had not eaten or taken any medications at this point). At 9:20 a.m. went back to bed and slept solid for 2 hours. Continued to feel poorly most of day with low grade temp of 99-100 degrees F. Rested several times during the day, noting achy muscle areas and just plain weakness. Slept fairly well and arose Monday a.m. 3-11-2019 feeling better without any temperature elevation, nausea or general malaise. Of note, the fever was not exceptionally elevated, as would be with the flu, no headache, diarrhea or vomiting. Body aches subsided after Sunday 3-10-2019 p.m. was just tired after that time.
Patient is a 68 y.o. female with a past medical history of IFG that presented to the ED this evening due to left sided weakness and decreased coordination.  Was also found incidentally to be COVID-19 positive on admission, patient asymptomatic and hemodynamically stable.
This case was reported by a physician via call center representative and described the occurrence of injection site numbness in a 28-year-old male patient who received FLUARIX QUADRIVALENT. In 2015, the patient received FLUARIX QUADRIVALENT. On an unknown date, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site numbness and skin disorder. On an unknown date, the outcome of the injection site numbness and skin disorder were unknown. It was unknown if the reporter considered the injection site numbness and skin disorder to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced skin indentation and numbness at the injection site. It was noted that the patient was on the bigger side.
body aches; abdominal pain; fever of 102.4; headache; This spontaneous report was received from a physician assistant (also the patient's mother) and refers to a 13-year-old non-pregnant female patient with an allergy to amoxicillin. She had no pertinent medical history or concomitant medications. On 18-MAY-2020, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot number and expiration date were not reported) intramuscularly for routine vaccination. On 19-MAY-2020, the patient woke up in the morning with a fever of 102.4 (unit not provided), a headache, body aches and abdominal pain. She was given ibuprofen as treatment for the events and did not seek medical attention. No lab diagnostics or studies were performed. On 19-MAY-2020, the patient recovered from the events. The relatedness between the events and the suspect therapy was not reported.
Pateint states that she has a swollen armpit.  It is not red or warm.  It is just tender.   SHe had a temperature of 99.2 yesterday.
02/13/05-fever, 02/15/05-diarrhea, 02/17/05-rash, 02/18/05- symptoms resolving per mother.
severe inflammation in his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 11May2021 06:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: EYE INFLAMMATION (non-serious) with onset 11May2021 09:00, outcome "unknown", described as "severe inflammation in his eyes".  Additional information: Caller was mom who explained yesterday her son had the Pfizer Covid 19 shot at 6:00, three hours later at 9:00 he had severe inflammation in his eyes. She didn't know what to do or where to go. She called the (withheld) where he got the shot but no one was there, no one answered. She would like to what was the reaction was. She doesn't know why he had this reaction and would like us to tell her what caused it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient returned to vaccination site at 0845 reporting swelling at vaccination site, pain in left arm/elbow and pain in the chest upon inhalation. Swelling of left hand and arm as well.  No shortness of breath or palpitations reported.
Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.
pt recv vax 21MAY97 & 22MAY97 pt exp flu like sx included nausea & vomiting by 23MAY97 pt recovered;
pt recv vax; 5 days later, had large supraclavicular node, very tender; no oth sx; did have localizing sx that had resolved
Within 24 hours of IZ administration - Next morning - I noticed Full body Rash except diaper area & soles of feet. Generalized macular papular lare Hive Rash to face Torso & All 4 extremities. No itching & blanching 7mo Infant exam did not seemed to be bothered by Rash. Cannot associate Rash to vaccine, had same vaccines @ 2 & 4 months. Patient had no other signs of viral exanthem. No fever. No running nose.
itching; red; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, EZETIMIBE, LISINOPRIL, RIVAROXABAN (XARELTO) and SOLIFENACIN SUCCINATE (VESICARE) for an unknown indication.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Vaccination site pruritus and Vaccination site erythema, at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (red) had resolved.        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.