chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SINUS PRESSURE; FELT FOGGY, A LITTLE BIT OUT OF IT; LEFT SORE ARM; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies/ had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced left sore arm, and fatigue. On 02-AUG-2021, the patient experienced felt foggy, a little bit out of it. On 06-AUG-2021, the patient experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt foggy, a little bit out of it on 04-AUG-2021, sinus pressure on 20-AUG-2021, left sore arm on 02-AUG-2021, and fatigue on 03-AUG-2021. This report was non-serious.
Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient received a Pfizer COVID-19 Vaccine prior to getting a Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Patient already received Moderna bivalent last year but wasn't documented in his covid vaccine card. He received another Moderna bivalent booster today by vaccinator. Vaccinator wasn't able to check on site until after due to slow wifi (in the basement). Patient was monitored for 30 min, Vital signs stable, NO ADVERSE REACTIONS noted.
Swelling at the injection site; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-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 VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No adverse events, just reporting a vaccine error.  Patient was given both MMRV and Varicella instead of MMR and Varicella.
During the night about 15 hours after receiving my 2nd dose I had very cold toes.  They were warm to the touch on the outside but I felt like they were very cold.  I put on wool socks, added a blanket and took 2 Advil and after a while the cold feeling diminished (but didn't go away).  Eventually the following morning I didn't have the cold feeling anymore.  I also had the typical post vaccine low grade fever and fatigue.  All of these symptoms were gone within 36 hours of getting the vaccine.  I have talked to others who had the same "cold toes" symptom as me, one of them still has it sometimes.
Throat closing up; Severe neck ache; Arm sore; Really bad ache; Head is pounding; A spontaneous report  was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe neck ache/neck pain, head is pounding/headache, arm sore/pain in extremity, really bad ache/pain, throat closing up/throat tightness.  The patient's medical history was included cortisone shot in 2010 and almost lost her foot, asthma, severe celiac disease, irritable bowel syndrome, myalgia, being seen at clinic for stomach issues, nerve pain, muscle pain, two discs in neck, fibromyalgia, anxiety, post-traumatic stress syndrome and had been in the emergency room five times in four and a half months. Concomitant medications were included nortriptyline, sertraline hydrochloride, fluticasone propionate, salmeterol xinafoate, inhalers for drug use for unknown indication and the patient was on gluten diet.  On 18 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced severe neck ache, head is pounding, arm sore, bad ache and throat closing which has a risk of death (life threatening).   No treatment information was provided. Laboratory exams were not performed.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe neck ache, head is pounding, arm sore, bad ache, throat closing up was unknown at the time of this report.; Reporter'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.
pt recvd DTP 20MAR78 & on 18APR78 fever 101 & grand mal sz lasting 1 hr; hospitalized, controlled w/PB; another vax given 22MAY78, followed (?date) by fever 101 & lt focal seizure lasting 1 hr; frequent prolonged sz;  severely retarded;
Severe joint pain and stiffness. Slight fever, sharp shooting pain and tingling in arms and legs. Severe muscle weakness. Difficulty swallowing.
Pt experienced phlegm build up in the laryngeal area after receiving Fluvirin and Pneumovax vax. The pt is currently seeing a speech therapist due to the phlegm build up. The pt has told her GP that the problem dated from 10/1997, when she received the vax.
I have the problem in my lungs, I got inflammation inner lining of my lungs; I am sick and having big problem after getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that, the patient had big problem after getting the vaccine. The patient was getting very sick from the Pfizer Covid-19 Vaccine and patient had problem in lungs, got inflammation in inner lining of lungs. The outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow up information has been received from the registered nurse who provided patients' details. This report refers to a 6 months old infant patient of unknown gender. On 21-JUN-2014, the patient was vaccinated with a dose of PEDVAXHIB lot number J016188, expiration date: 02-OCT-2016, (dose and route were not reported) that was improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Pt recvd vax 5MAY93 & devel t102, vomiting, not eating, rash, listless; pt covered w/red blotchy rash on arms, face & legs; feet swollen bottoms of feet red;
Dizziness, Fever, NauseaVomiting, sweating Narrative: Per supervisor report: "Received second covid vaccine on 2/23/2021. Experiencing sweating, fever, nausea, light head."   Other Relevant History:
Coldness in right arm immediately following injection and stayed cold for approximately 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 17Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included MS (multiple sclerosis). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexamethasone (DECADRON), heparin (MANUFACTURER UNKNOWN) and diazepam (MANUFACTURER UNKNOWN); all taken for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 17Apr2021 at 10:00, the patient experienced coldness in right arm immediately following injection that stayed cold for approximately 48 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event coldness in right arm immediately following injection and stayed cold for approximately 48 hours was resolved on 19Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; headache (HA); I felt light headed when I went to stand up and I was taken by wheelchair to the ED; my heart started racing; high blood pressure; Sinus tachycardia at 105 bpm; This is a spontaneous report from a contactable nurse. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EJ1685), via an unspecified route of administration on 28Dec2020 09:00 at a single dose for covid-19 immunization. The patient's medical history included allergy to fish but patient had a type of fish she was not allergic to on 01Jan2021. Concomitant medications were not reported. The patient received first vaccine on 28Dec2020 at 9:00 am. After about 5-15 minutes her heart started racing, she felt light headed when she went to stand up and patient was taken by wheelchair to the emergency department (ED). The procedures done in ED included Stat EKG which showed sinus tachycardia at 105 bpm and high blood pressure. Patient was normotensive normally. ED gave her Benedryl and pepcid. It took about 3 hours for my heartrate and BP to go back to normal in ED for 3 1/2 hours. Patient takes allergy meds everyday, allegra. The patient stated she went to bed and woke with headache (HA), (tylenol and ibuprofen were taken) lasted for 2 hours and returned the next day and patient took more ibuprofen and then it went away. The patient was allergic to fish, but she had a type of fish she was not allergic to on 01Jan2021 and had diarrhea within 30 minutes (one time occurrence). It was reported that the patient wishes to take the 2nd vaccine and has had no further adverse events. The outcome of the event was Headache (HA), heart rate increased  and high blood pressure was recovered on an unknown date and unknown outcome for the remaining events.
Administration Error: o         Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. o         1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. o         This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. o         The dose given out of this vial was 0.3 ml. o         The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg.  Pfizer Case #: int00506363
Incorrect diluent amount added to vaccine vial. Use .8 of diluent instead of 1.8cc.
Pt passes out after vaccine administration, fell out of chair, and hit her head on the chair.
COVID-19; Lack of efficacy; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Apr-2021. The most recent information was received on 17-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). On 17-Apr-2021, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant and treatment medications were reported.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The causality for the event of drug ineffective remains as possible.   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: Follow-up received on 4-06-2021 included no new information On 17-Apr-2021: Upon internal review on 14 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related. The causality for the event of drug ineffective remains as possible.
Information has been received from a health professional concerning a female child who, "years ago", was vaccinated with a dose of MMR II. Subsequently, "years ago", the patient developed Stevens Johnson Syndrome, erythema multiforme, urticaria and rash. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Stevens Johnson Syndrome was considered to be an other important medical event. Additional information is not expected.
Patient had difficulty swallowing and dry mouth. Was given Epinephrine, Benadryl, and Fomotodine and transported from the clinic site the Emergency Room. The effects subsided after 2.5 hours, approximately 10 pm. Observed in the ER for 4 hours.
Has no immunity; This spontaneous report was received from a female adult patient of an unknown age concerning herself. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On an unknown date (reported as the best dates she has was between 1981 and 1985), the patient was vaccinated with varicella vaccine  (manufacturer unknown) (dose, frequency, units, route, batch, lot# and expiry date were unknown) for prophylaxis. The patient was involved in adult clinical trial on varicella vaccine (the patient was sure it was a Merck study. However, she didn't had identification card which contains the MK#, protocol# and investigator information). During the study, some people got one dose while others got two doses. It was reported that when the merck study performed the testing, the study stated the patient had immunity. When she went to a unspecified tester, the results of the "regular testing" showed she had no immunity (therapeutic non-responder). The outcome of the event was unknown. The reporter did not provide any causality assessment. No product quality complaint (PQC) was involved.
Skin rash/ hives on elbows, knees, shins, torso, buttocks
His arm is red [and swollen/very swollen arm]; [His arm is red and] swollen/very swollen arm; 28 months old child was received Flucelvax Quadrivalent vaccine; This is spontaneous case, initially received from other health professional (nurse) via Company (reference number: SEQ19-04031, SEQ19-04534) on 07-Oct-2019 with additional information received on 11-Oct-2019 (being processed together), concerning a 2.5-year-old, male patient.  The patient had no medical history and concomitant medications.  On 06-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: right arm, batch number: 261220, expiration date: 30-Jun-2020] for influenza prophylaxis (explicitly coded as Inappropriate age at vaccine administration').  On the same day, after vaccination, the patient's arm was red and swollen. The patient's parents monitored him, and his mother reported that the patient was fine, except a very swollen arm.   As reported, a week, to a week and a half after vaccination, the patient recovered.  The reporter assessed the case as non-serious and did not provide causality assessment.  Follow up received from other health professional (nurse) via Company (reference number: SEQ19-04936) on 17-Oct-2019: Age at vaccination added. The outcome for swollen arm was provided and changed from resolving to resolved. Stop date was added. Event of arm red was added. Narrative was amended accordingly.  Company comment: The patient experienced erythema and peripheral swelling after Flucelvax QIV administration to patient of inappropriate age. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Product administered to patient of inappropriate age is assessed as not related per company conventions. Considering all the above mentioned, causal role of the suspect product is assessed as related.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Interstitial lung disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; FLOVENT; PROAIR [FLUTICASONE PROPIONATE]; AZELASTINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: To update of slide#1 reporter.
Information has been received from a health professional concerning a 39 year old male who was vaccinated with zoster vaccine live (Oka/Merck) instead of VARIVAX. This was an error. The reporter did not know zoster vaccine live (Oka/Merck) was in the freezer and picked up the wrong vial. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Vaccinated on 8/18/03. Client complained of site being itchy. Mom states that site was red, swollen and hot. Fever of 102. Mom gave tylenol. Child has been active but somewhat irritable since inj. Mom still giving Tylenol, Temp today 100.06 Axilla. Today site red warm and itchy. C/O pain at site (lt arm).
? 1st dose Pfizer on 05/01/21, 2nd on 05/22/21. Patient was 14 at the time of 1st dose and turned 15 by their 2nd dose ? DOB    No adverse effects to report. Just the age at the time of their first dose.
Pt states having a huge swollen area about 4 inches, as well as pain in arm and shoulder to the point of not being able to lift arm for 5 days. Pt took Aleve to reduce pain, and she is feeling better now.
H1N1 vaccine given IM on 11/2/09. Mother and brother have noticed episodes of stuttering and "acting like he cannot talk" although his mouth is moving sporadically. Pt states his head "feels funny and vibrates".
hair started falling out, when she brushes her hair there has been alot of hair in her brush
pt recv vax 16FEB96 & 5MAR96 exp periorbital rash & itchy, irritated eczematous around the eyelids;tx w/med w/o resolution;exp required a MD visit;
My adverse event began on 2/5/2021, I started feeling bloated and nauseous and later on in the evening, I found it was difficult to lie flat. This difficulty increased along with some sharp chest pain until I went to the ER 2/7/2021. CT scan was done of the abdomen was clear and chest was full of clots. CPA showed mild clot burden. Ultra sound in both legs showed negative and ECG was clear. Physician stated it looked like something that would have been something they see with COVID infections.
Stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiffness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 36 hours after I received the first Moderna vaccine, I developed a high fever 101.5, chills and body aches lasting about 4 days. I went to healthcare facility and had a negative influenza and Covid tests at that time. 2 days later, I started to have difficulty breathing. I had a routine doctor appt scheduled for 3/25. When I arrived, my O2 sats were 80% and I was sent to the ER. There I had another negative Covid test. I was diagnosed with bil PE's and had a 8 days stay in the hospital, 6 days in ICU. I was sent home on long term medications and oxygen.