chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES; THROAT SWELLING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hereditary angioedema, and atrial fibrillation, and other pre-existing medical conditions included the patient did not have any known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, metoprolol for atrial fibrillation, and sotalol for atrial fibrillation. On 02-MAY-2021, the subject experienced throat swelling. On 03-MAY-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: icatibant acetate. The action taken with covid-19 was not applicable. The patient recovered from throat swelling on 02-MAY-2021, and had not recovered from body aches. This report was non-serious.
pt recv vax & the same evening the pt was very irritable; The following day had completely recovered;
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 27-JUN-2013, the patient was vaccinated with ZOSTAVAX (lot # J001693 and expiry date 08-MAY-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Nausea  Vomiting  Headaches Vertigo  Dizziness  Spins Light headed Weak Lethargic Lack of focus Scattered brain
burning sensation around the injection site; sore arm; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site burning and pain in arm. On an unknown date, the outcome of the injection site burning was unknown and the outcome of the pain in arm was unchanged.   It was unknown if the reporter considered the injection site burning and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after her first dose of Shingrix just had a sore arm and a burning sensation around the injection site. For tolerance after 2nd dose refer case US2020AMR211569.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR211569:same patient, 2nd dose
Painful arm; fatigue set in and I haven't been able to shake it off; the pain came back a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), FATIGUE (fatigue set in and I haven't been able to shake it off) and PAIN (the pain came back a little bit) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful arm), FATIGUE (fatigue set in and I haven't been able to shake it off) and PAIN (the pain came back a little bit). At the time of the report, PAIN IN EXTREMITY (Painful arm), FATIGUE (fatigue set in and I haven't been able to shake it off) and PAIN (the pain came back a little bit) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Shortness of breath, dizziness, pain in chest and body.  Required to sit and wait 40 minutes till symptoms went away.   Staff took blood pressure, and temperature before allowing to leave pharmacy.   Took one Benadryl upon arriving at home.
all of a sudden gets a stabbing pain in the middle of the night; not able to move shoulder or arm because of the pain; could not move the shoulder/arm; limited range of motion in the area; sore; extreme pain in the site area; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night) and ARTHRALGIA (sore) in a 49-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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm) and JOINT RANGE OF MOTION DECREASED (limited range of motion in the area). On an unknown date, the patient experienced PAIN (all of a sudden gets a stabbing pain in the middle of the night). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (not able to move shoulder or arm because of the pain), HYPOKINESIA (could not move the shoulder/arm), JOINT RANGE OF MOTION DECREASED (limited range of motion in the area), PAIN (all of a sudden gets a stabbing pain in the middle of the night), ARTHRALGIA (sore) and INJECTION SITE PAIN (extreme pain in the site area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-010401 (E2B Linked Report).; Sender's Comments:  MOD-2021-010401:
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 21-OCT-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Local reaction at site of left arm. Inflammation/ erythema and warmth. Reactions > 48hours.
I had a large, hot, solid bump on my arm. It itched and got red as well as progressively larger over the following days. It continues to itch. I am applying cortisone cream and an ice pack.
After receiving referral from  Family Medicine ,I called and spoke to patient regarding monoclonal antibody infusion. He became symptomatic on 3/16, was tested on 3/19, and tested positive on 3/21 at  Family Medicine  (PCR). He is a candidate based on his BMI> 35, DM. I reviewed EUA for Casirivimab/Imdevimab and reviewed risks vs benefits with the patient. Discussed need to wait 90 days from infusion to get COVID vaccine. Also discussed the newness of medication and inability to know all possible side effects. They would like to proceed with the infusion. We discussed coming in via the side door at the 6th and Folks office for appt tomorrow, March 23rd at 9 am. Call  when they arrive. Discussed time frame for infusion. All questions and concerns were addressed. Patient agreeable and will arrive at above stated date and time.
Started the following day December 29th about 9PM having diarrhea. Diarrhea continued on December 30th. Also on December 30th my left eye began to swell. I took benadryl that evening before going to  bed, but woke up the next morning December 31st with both eyes swollen. The left eye being worse and now under the eye was red and extremely itchy. Contacted employee health at hospital on December 30th and 31st. where vaccine was given and left a message detailing  my side effects. Contacted my own primary dr on December 31st and was seen by Dr who believes I have had an allergic reaction to Moderna vaccine. I was prescribed predinsone and zyrtec for 5 days.
Patient seemed confused and agitated within a few minutes of administration. She started to pace and I noticed she looked panicked and very pale. Patient was placed on the ground, feet elevated and an ice pack placed on her head. Patient did not lose consciousness at any point.  Symptoms began to improve within 5 minutes and she felt fully recovered, just tired within 20 minutes. Patient was observed for 15 more minutes and did not experience any further symptoms.
Pt recvd 1 dose of Engerix-B & on 12JUL92 devel a herpetic rash from the waist down & on both legs;
1hr post vax p/exposure to cold weather pt started coughing-went home & had ventolin;pt devel a rash all over & eyes were swollen;pt advised to go to immed emergency care ctr;epi & DPH given;
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 12 months old infant patient and unknown gender. On 09-SEP-2014 the patient was vaccinated with a PROQUAD (Merck) (lot K006771, expiration date 07-NOV-2015) (dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 18 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
c/o groin area hurting;MD called;15JUN97-16JUN97 pt hurting all over body;no swelling;crying alot;17JUN97 sl ear infect;18JUN97 swelling & ankles & elbows, rash on face, fever of 100.8;MD orders blood tests-poss JA;couldn't walk;
Rapid +; Rapid +; Stuffy nose; post nasal; headache; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunization. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced Stuffy nose, post nasal drip, headache, Rapid +. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The clinical outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received 0.25ml dose instead of 0.5ml dose, no adverse symptoms reported.
Pruritic rash consisting of wheals that presented within 1-2 hours of FLUCELVAX vaccination. Treated with BENADRYL 25mg prn. Rash covers face and neck only.
Swollen Lip, Pain at site of injection and warmth, Fever and cough and arthralgia.
6MAR fever, cough; 8MAR cough freq & productive; 10MAR seen by MD wheezing, cough worse, fever, nasal discharge & RSV; 12MAR up & down t101; 13MAR spasmodic cough, nasal-green/yellow; 16MAR to hosp, admitted; dx: prob RSV r/o whooping cough
This spontaneous report was received from a nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 25-JAN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number M023169, expiration date 13-JUN-2018, dose, route and anatomical application were not reported) for prophylaxis. No adverse event was reported.  The temperature of storage was 32 °F, and the time frame was 8 hours 30 minutes. Previous temperature excursion was not reported and a data logger was involved. A product quality complaint was not involved. Additional information is not expected as there is no consent to contact the reporter.
Patient fainted in the immunization room after immunization had been provided.  Patient claimed to always faint after vaccines.  Patient also vomited after fainting and having a drink of water.
headache, productive cough at times, fever, chills, body aches, loss of smell, diarrhea, sinus congestion, post nasal drainage, sneezing. starting 11/13/21
A report has been received from a Health Professional concerning a 5 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter stated patient has been administered FLUMIST QUADRIVALENT twice this season which started on 22-Sep-2014. The outcome of the event of patient received FLUMIST QUADRIVALENT twice this season is unknown. The report was considered to be non-serious.
After the first shot I could barely move my left arm and with in a few days I had pain on my left side of my stomach. This pain got worse and spread to mostly my left side back, leg, arm. And is now all over. It?s a horrible burning stabbing pain. Within a week after my second shot my left arm went numb while driving and currently experiencing random numbness and tingling in my left foot and arm. Also on May 9th my left calf got a charley horse feeling for 3 days nonstop. This will come and go but that was the longest it lasted.
A week later her arm started hurting/pain at injection site; [A week later her arm started hurting /pain at injection site; This is a spontaneous case, reported by a pharmacist to Agency (reference number: SEQ19-05122) and initially received on 18-Oct-2019, concerning a 77-year-old female patient.  The patient's relevant medical history and concomitant medications were not provided.  On 11-Oct-2019, the patient was administered Fluad (TIV) [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, anatomical location: right deltoid, route of administration: intramuscular, batch number: 260389, expiration date: 20-May-2020] for influenza prophylaxis.  On 18-Oct-2019, 7 days after vaccination, the patient reported pain at injection site but no redness or swelling. The patient's arm started hurting. The patient had no problems moving or lifting her arm.  The outcome of the event 'Injection site pain' and ' Pain in arm' was recovering.  The reporter assessed the case as non-serious and did not provide causality assessment to Fluad (TIV).  Follow up received from pharmacist on 29-Oct-2019: patient initials, start date and the outcome of the event 'Injection site pain 'Pain in arm' and were updated. The narrative was amended accordingly.  Company comment: The patient experienced injection site pain and pain in extremity after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as possibly related.; Sender's Comments: The patient experienced injection site pain and pain in extremity after vaccination with the suspect product Fluad (TIV). Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product is assessed as possibly related.
I accidentally placed the COVID-19 vaccine into the NaCl diluent vial, instead of placing the diluent into the COVID-19 vaccine vial. This was noticed prior to vaccination, and this wrongly mixed vaccine WAS NOT ADMINISTERED TO THE PATIENT. The wrongly mixed vial was discarded appropriately, and a new vial was mixed without issue.
Mother states he started a fever@ 1PM Fri. 1/30/09& by 8PM it was 104 degrees. Dr's office suggested alternating Motrin&Tylenol-it would go down then 4 hrs later up. Sat.1/31/09PM it was 105.8 degrees-went to ER-they got it down in a few hrs. Took him to Dr's office 2/2/09-No other signs of infection-He concludes it is a reaction to Flu shot. Fever continued till Wed.2/4/09. Today has some aches but NO fever.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2015, the patient was treated by a physician, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 52 year old female patient with allergy to sulfa drugs. In September 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported). In September 2012 patient had an injection site reaction: swelling, erythema, a walnut-sized pus-filled blister/rash, and inflammation from shoulder to elbow with warmth. She was hospitalized for 2 days. The vaccinated was administered by a physician and the ZOSTAVAX was given in the same arm as an unspecified flu vaccine. The patient seek medical attention by being sent to ICU and was treated with vancomycin, unspecified pain medication. The outcome of events was unknown. Additional information has been requested.
Developed a rash -- some bumps in a stripe pattern--a few d after vaccination. Does not bother her.
This case was reported by a consumer via call center representative and described the occurrence of rash urticaria-like in a 79-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date unknown) for prophylaxis. On 7th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced rash urticaria-like and itchy rash. On an unknown date, the patient experienced blotchy rash. The patient was treated with Triamcinolone Cream. On an unknown date, the outcome of the rash urticaria-like, itchy rash and blotchy rash were recovered/resolved. It was unknown if the reporter considered the rash urticaria-like, itchy rash and blotchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient provided lot number but did not have expiration date for his dose. The patient received SHINGRIX in the right arm. Later in Dec 2018, the patient experienced rash that looked like hives and was itchy. It was resolved with use of triamcinolone cream. Less than a year after receiving vaccination, the patient also reported that, later if the rash would occur on another part of his body in a blotch, he would treat it and it would go away. The patient gave consent to follow up.
chills; Arm sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NAPROXEN, LEVOTHYROXINE SODIUM (SYNTHROID), NAPROXEN, DOXYLAMINE SUCCINATE (UNISOM 2), MELATONIN and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (chills) and VACCINATION SITE PAIN (Arm sore). At the time of the report, CHILLS (chills) and VACCINATION SITE PAIN (Arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age. The patients were vaccinated with MMR II (lot number, dose, route and injection site were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. An unknown number of patients had been administered MMR II that was improperly stored since 26-OCT-2012. The reporter was unable to provide the exact number or identities of the patient involved at the time of the report. No adverse effects reported. The outcome was unknown at the time of report. It was unspecified if the patient sought medical attention. Additional information has been requested.
REDNESS AND SWELLING AT INJECTION SITE ABOUT 10 CM IN DIAMETER - SYMPTOMS IMPROVED AFTER 48HRS