chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Stuffed-up nose, felt like it was full of cement; Throat was very dry; She felt like she was choking; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffed-up nose, felt like it was full of cement), DRY THROAT (Throat was very dry) and CHOKING SENSATION (She felt like she was choking) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Seasonal allergy. Concomitant products included METOPROLOL, AMLODIPINE BESILATE (NORVASC) and B & FOLIC for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffed-up nose, felt like it was full of cement), DRY THROAT (Throat was very dry) and CHOKING SENSATION (She felt like she was choking). At the time of the report, PAIN IN EXTREMITY (Sore arm), NASAL CONGESTION (Stuffed-up nose, felt like it was full of cement), DRY THROAT (Throat was very dry) and CHOKING SENSATION (She felt like she was choking) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Arm was swollen 3 times its size from below were shot was given to elbow, very red (blueish), feverish & sore; MD put pt on ATB for infect & told mom to use ice packs;
Mother of child called states that child after one day of having IPV shot had reaction after sore throat, headache & not feeling well. States no fever but feeling sore whole body.
Information has been received from a physician concerning a 59 year old male patient with hypertension, chronic obstructive pulmonary disease (COPD) and "cholesterol" who on 01-APR-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. Concomitant vaccination included a dose of DTAP. On 02-APR-2010 the patient experienced fever, headache and nausea after getting PNEUMOVAX 23. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Arm swelled at site of injection and itched numbness in some areas and constant ache still remain, pt has hard time grasping objects.
Patient developed a three inch rash around DTaP injection site and had a 101.3f ear temperature in the first two days. By day three it grew to over five inches. Pt has abnormally complained of pain at the injection site, stomach pain, and headaches. The rash itches and is still hot to the touch. He began having diarrhea within 24 hours. Currently on day six with little improvement of any symptoms.
This spontaneous report as received from a medical assistant refers to a 18 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 19-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2014) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. Addtional information has been requested.
Warmness at the injection site; Itchiness at the injection site; 2 1/2 inch pink area surrounding the injection site; Arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (2 1/2 inch pink area surrounding the injection site) and VACCINATION SITE PAIN (Arm was sore at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore at injection site). On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (2 1/2 inch pink area surrounding the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (2 1/2 inch pink area surrounding the injection site) and VACCINATION SITE PAIN (Arm was sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information include Ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow-up received on 22-Mar-2021 included no new information. On 08-Apr-2021: Follow-up received on 08-Apr-2021 included no new information.; 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.
dad states pt c/o dizziness on 12AUg92 was sent home from daycare that AM; subjective fever; rt upper arm red, warm to touch, tender; t100.8; Rx w/APAP;
Patient said arm became numb 5 min. after vaccination and returned to work.  Returned in 30-40-minutes to report numbness, had patient sit and observed for 20-30 minutes, at which time said numbness fading.
Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; Throughout the night I suffered from Muscle pain, Chills, Nausea, and a general body ache; This is a spontaneous report from a contactable healthcare professional.  This 30-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm on 23Dec2020 at 15:00 ( at the age of 30 years-old) as a single dose for COVID-19 immunization. The COVID-19 vaccine was administered at a facility. Medical history included an allergy to bee venom. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On 24Dec2020 at 0100, the patient had muscle pain, chills, nausea and a general body ache. He was not hospitalized nor treated for the events. The clinical outcome of the events of muscle pain, chills, nausea and a general body ache was recovering. Since the vaccination, the patient has not been tested for COVID-19.
symptoms began 02/02/21 that night and lasted about 24 hours.  headache, muscle aches, nausea, fever, chills, right arm soreness
This spontaneous report was received from a registered nurse. On an unknown date, the primary reporter stated that the cover of PROQUAD subcutaneously (lot number M043310 and expiration date 24-APR-2018) and the sterile diluent (lot number and expiration date were not reported) were very similar. The medical assistant inadvertently put the PROQUAD in the drawer and the sterile diluent in the freezer because the end cover was very similar to PROQUAD and the sterile diluent and it was easy to make the mistake. No doses of PROQUAD and the sterile diluent were administered to any patient, therefore, no adverse effects were reported. No further information was provided. Additional information has been requested.
At 4 month WCC visit, parents reported that about 72 hours after vaccines, patient developed torticollis. Symptoms resolved slowly over next 2 months; minimally present at 4 month WCC. Parents are concerned this related to vaccines. Born full term/healthy.
Heat, induration , pain, whole of left upper arm. Tx with pain medication and antihistamine.
Numbness and tingling in upper right arm.  Sought treatment at urgent care. Recommended treatment is NSAIDs and ice to reduce inflammation.  Also recommended to follow up with neurologist if symptoms persist for more than two weeks.
A report has been received from a health professional, concerning a 2 year old, female patient. No medical history, concurrent disease or concomitant medication was provided. On 08-Nov-2012, the patient received nasal FLUMIST. According to the reporter, it was not sure if FLUMIST went into a patient's eye. The patient squirmed, and some of the product landed on her face near her eye. It was possible that some may have gotten in her eye. At the time of reporting, the outcome of the event of FLUMIST went into a patient's eye was unknown. The report was considered to be non-serious by company physician. Corrected report 13-Dec-2012: Coding of FLUMIST went into a patient's eye was changed from accidental exposure while administering drug to drug administration error.
arm hurting; migraine; did not feel well for 10 days; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN (ADVIL 12 HOUR) and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (arm hurting), MIGRAINE (migraine), MALAISE (did not feel well for 10 days), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Vitamins were used as concomitant medications. No treatment medications were reported. Action taken with mRNA-1273 in response to the event/s was not applicable.   This case was linked to MOD-2021-117042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08  JUN  2021 contain information include event outcome updated.
Patient was in for a 2 month well child. She was supposed to get the combination vaccine PENTACEL but instead was given PEDIARIX-which was okay, except for she received an extra Hepatitis B vaccine.
size of half baseball; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site). At the time of the report, MASS (size of half baseball) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not provided. Treatment was not given. Patient had recently been diagnosed that her kidney is not filtering properly.
Pt recvd 1st dose of Hep B vax on 29JAN92; On 7FEB92 pt devel a red, raised rash on throat & face;
covid-19; covid-19; vaccine brand other=MODERNA/vaccine dose number=4,3,2,1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 08:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing); "Significient multilevel lumbar spondylosis" (unspecified if ongoing), notes: Significient multilevel lumbar spondylosis; "Obesity" (unspecified if ongoing); "known allergies :Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2010, stop date: 01Jan2023; AMLODIPINE BESYLATE, start date: Jan2010, stop date: 01Jan2023; METOPROLOL SUCCINATE, start date: Jan2010, stop date: 01Jan2023; TOLTERODINE TARTRATE, start date: Jan2016, stop date: 01Jan2023; FINASTERIDE, start date: Jan2016, stop date: 01Jan2023; MEMBERS MARK WOMEN 50+ MULTIVITAMIN, start date: Jan2021, stop date: 01Jan2023; ZINC COLD THERAPY, start date: 21Dec2022, stop date: 01Jan2023; MUCINEX DM; DAYQUIL SEVERE COLD & FLU. Past drug history included: Known allergies: zocor, reaction(s): "Known allergies: ZOCOR"; Known allergies: flowmax, reaction(s): "Known allergies: Flowmax"; Known allergies: cozaar, reaction(s): "Known allergies: Cozaar"; Known allergies: niaspan, reaction(s): "Known allergies: Niaspan"; Known allergies: sulindac, reaction(s): "Known allergies: Sulindac". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Nov2022 at 08:45, outcome "unknown", described as "vaccine brand other=MODERNA/vaccine dose number=4,3,2,1"; DRUG INEFFECTIVE (medically significant) with onset 22Dec2022, outcome "not recovered", COVID-19 (medically significant) with onset 22Dec2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Dec2022) Positive. Therapeutic measures were taken as a result of covid-19 which include paxlovid from 22Dec2022 to 27Dec2022.  Clinical course: The patient received other medications within 2 weeks include Omega-3 Krill Oil 500MG and Vicks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000114 Same patient, different product and event;
5hr p/vax pt devel generalized cutaneous urticaria;resolved over 2-3 days;not allergic to eggs;
This spontaneous report was received from a pharmacist refers to a 78 year old patient of unknown gender. The patient had previous administration of PREVNAR 13. On 03-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 (lot # M033086 and expiration date 05-MAY-2018) 0.5 ml, unknown route (reported as indication for vaccination). No concomitant medication were reported. On 03-OCT-2016(reported as within 24 hours of receiving PNEUMOVAX 23 the patient experienced warmth, redness and swelling below the injection site. The patient sought medical attention by calling the pharmacy on unspecified dates. The outcome of the events was reported as unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed. This case is cross linked with MARS# 1610USA012553 (same reporter link). Additional information has been requested.
Shoulder around injection site still has pain. Usually the pain is behind the or at the side of the injection site. The pain comes and goes and it is noticeable. I still have full range and use of my shoulder.  However, after four months of having the shot, it is strange how the pain/soreness is still there. My doctor said either to have physical therapy or to try to self therapy which I choose to do.
Patient had 3 vaccines: hep A, Meningococcal, and Tdap. symptoms:pain in arms, fever, chill, headache, tiredness, and nausea.
Service member received Moderna Vaccine Dose 1 on 01 FEB 2021. Service member experienced skin irritation, redness, and hives within an hour of receiving the vaccine.  After going back to work, SM's symptoms worsened with itchiness and throat soreness. Symptoms progressed at home and noticed hives all over body and swelling around the face. Patient saw a provider in Clinic. He was prescribed Prednisone and Zyrtec which provided relief and symptoms improved and were mostly gone by Day 4. Instructed by his commander and provider to refrain from getting second dose of the vaccine.
A TYPICAL YEAST INFECTION; HAIR STARTED TO FALL OUT IN THE SHOWER AND WITH BRUSHING; ECZEMA ON BOTH HANDS AND ARMS; HEADACHES ON/OFF LIKE MIGRAINES; CHEST PAIN; LOST APPETITE COMPLETELY AND READY TO PASS OUT FROM HUNGER/NOT EATING.; LIGHTHEADED; EXTREME CHILLS; FEVER; HOT/COLD SENSATIONS; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight was 196 pounds, and height was 66 inches. The patient's concurrent conditions included: sesame seeds allergy, and penicillin allergy, and other pre-existing medical conditions included: The patient was very healthy, never had any health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-SEP-2021, the patient experienced hot/cold sensations. On 08-SEP-2021, the patient experienced extreme chills. On 08-SEP-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 105.0 F. On 09-SEP-2021, the patient experienced lost appetite completely and ready to pass out from hunger/not eating. On 09-SEP-2021, the patient experienced lightheaded. On 10-SEP-2021, the patient experienced chest pain. On 11-SEP-2021, the patient experienced eczema on both hands and arms. On 11-SEP-2021, the patient experienced headaches on/off like migraines. Laboratory data included: Electrocardiogram (NR: not provided) Normal. On 18-SEP-2021, the patient experienced hair started to fall out in the shower and with brushing. On 19-SEP-2021, the patient experienced a typical yeast infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, hot/cold sensations, extreme chills, and fever on SEP-2021, was recovering from eczema on both hands and arms, and a typical yeast infection, had not recovered from hair started to fall out in the shower and with brushing, and the outcome of lost appetite completely and ready to pass out from hunger/not eating., headaches on/off like migraines and lightheaded was not reported. This report was non-serious. This case, from the same reporter is linked to 20211000473.
I have had a history of migraines since I was a small child, but they have been stable for many years. I usually have about two migraines a month, same symptoms, usually easily controlled with Excedrin migraine. Of note, they do increase in frequency during stressful times. Shortly after receiving my vaccines, I noticed an accelerating increase in frequency and severity and significant change in symptoms with new changes in smell and taste, as well as new dizziness. I got care at urgent care and am now seeing neurology. I am now having daily migraines, for the last 4 months. They have been incredibly difficult to control, even on preventative medications. I have missed and cut back on work and activites with my family. I have never had an episode this severe
Body aches. Strong pain in the entire arm of vaccine. Headache. Fever reaching 100.9. Fatigue. Malaise.
Stomach ache; Took 1 dose of unrefrigerated Vivotif; Spontaneous report received on 16DEC2019.   Based on the information obtained from a caregiver (consumer's mother) two individual case safety report 19000468SP (PVX2019-3095-first child) and 19000469SP (PVX2019-3096-second child).   This case was (PVX2019-3095) for a male consumer who "took a dose of unrefrigerated Vivotif" (PT: Product storage error) and developed "stomach ache" (PT: Abdominal pain upper), while being oral Vivotif (Lot number: 3003279) for typhoid fever prophylaxis. On 15DEC2019, the consumer took first dose of Vivotif which was left unrefrigerated since 26NOV2019.On the same day following the administration of Vivotif, he developed stomach ache and did not receive any treatment for it. Action taken with Vivotif with respect to event "stomach ache" was unknown while, with respect to event "took a dose of unrefrigerated Vivotif" was not applicable. At the time of report, the outcome of the reported events was unknown.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and developed stomach ache. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.  Follow up information was received on 26DEC2019  The follow up information received included outcome of the event.  The outcome of the event "stomach ache" was updated as resolved without any treatment.  Additionally, the stomach issue began 4 hours after taking the first dose of Vivotif.  Company Comment: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and after 4 hours, had stomach ache. The event resolved without any treatment. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.; Sender's Comments: A consumer took a dose of unrefrigerated Vivotif (Product storage error) and after 4 hours, had stomach ache. The event resolved without any treatment. Considering the potential of Vivotif to cause abdominal pain, the event stomach ache is assessed as possible with Vivotif. The causality of product storage error is assessed as not related to Vivotif due to the nature of the event.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, these patients received improperly stored VAQTA (lot# M032492, expiration date 02-MAR-2018) (lot# M036459, expiration date 18-JAN-2018) (dose and route not provided). The improperly stored VAQTA were exposed to temperatures ranging from a minimum of 31.9F and a maximum of 35.5F for a cumulative time frame of 1 hour. No previous excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 19-MAR-2010 the patient was subcutaneously vaccinated with the first dose of RECOMBIVAX HB (dose and lot # not reported). Approximately on 25-JUN-2010, the patient received the third dose of RECOMBIVAX in the immunization series at an interval of 13 weeks from the first dose instead of the recommended interval of 16 weeks. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.