chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient was not pregnant. Drug allergies included: unspecified reaction to fluticasone. On 26-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J013555;expiry: 02-MAY-215. Concomitant therapies included megestrol acetate, pyridostigmine bromide, clopidogrel, glycopyrrolate, levothyroxine sodium (manufacturer unknown), omeprazole (manufacturer unknown), montelukast sodium (manufacturer unknown), metoprolol, albuterol sulfate (manufacturer unknown), SPIRIVA and VENTOLIN. Approximately on an unknown date in September 2014 pharmacist received PNEUMOVAX 23 on 26-SEP-2014 and had a reaction to it. Pharmacist reported that patient had a red color under her skin which ran down to her elbow and settled there. Pharmacist reported it looked like a capillary thing and patient said it itched. Treatment given was BENADRYL and cold compresses. Pharmacist inquired if PLAVIX interacted with PNEUMOVAX 23 since patient had that reaction. The outcome of the events was reported as recovering/resolving. Patient sought medical attention and went to pharmacist. Causality assessment was not provided. Additional information has been requested.
pt got  itchy small red bumps all over both arms and neck and lower part of face. it is worse around the injection site on the left arm .  she took a benadryl last night but it did not help so i told her to go to MD.  pt said she already contacted her Dr and the dr told her to go tell the pharmacist and then go to an urgent care. pt said she has no hives and no shortness of breath or trouble  breathing .
This is a spontaneous report from a contactable physician via Pfizer sales representative. A currently 77-year-old female patient of an unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the arm on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed swelling in the hand (of the vaccinated arm) over the course of 24 hours. The outcome of the event was recovering.
Randome sore throats experienced with no other symptoms. I wear a N95 Mask when outside and spray my hands with disinfecting spray when I come to my vehicle. I am never one to get a sore throat without other cold related symptoms. The pain of the sore throat is not very painful but it is felt. I have been feeling this for quite some time after the vaccinations. And my husband too.  I am able to take 400mg of Ibuprofin to get rid of the sore throat but will come back maybe 1-2 weeks later over and over like this.  And for me when I get a sore throat that means a cold is ensuing and then coughing and bad cough but these sore throats are without all that drama. I do not know if this is for sure the cause but I do think it is very suspicious.
Approximately 40 minutes following the injection, my chest tightened and I had problems breathing similar to when I had covid.  I used my albuterol inhaler and got relief.  I had to use my inhaler more frequently (about 3 or 4 times) over the next 24 hours. Approximately 20 hours following the injection, I got body aches similar to the flu and became extremely fatigued.  The aches and fatigue lasted about 48 hours after the injection.
Starting on day after receiving vaccine, patient began experiencing headache, body aches, fever, chills. This continued all of Friday, 10/17, and into Saturday, 10/18.
improperly stored vaccine administration in reference to temperature excursion; Information has been received from a other referring to a currently 4 years old unknown gender patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)(0.5 milliliter, lot # T005406, expiration date: 12-AUG-2021, frequency and route were not reported) for prophylaxis. The administered doses experienced a temperature excursion at  -9.5 C for 8 hours and 53 mins;  -10.1 C for 6 hours and 40 minutes. No previous temperature excursions. The temperature excursions were detected by a data logger (Product storage error).
SORE ARM.! PATIENT USED IBUPROFEN AND AN ICE PACK
Complains of malaise the evening of 08/07/2006 with slight swelling, redness at site, rash also noted around site.
Shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Feb-2023 Reporter's comment: This case was reported via interactive digital media. The reporter's brother had neighbor (patient) who got the Shingles shot and developed the shingles after the shot. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was one of 4 cases, reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028533:Same reporter
raised red rash or bumps on side of scalp 2cm long.  Saw NP who felt it might be immune system mounting response.  On 9/29/09 saw lump on side of neck and given HC cream.  Rash moving on left side of face.
My right arm has been sore for the past 4-6 weeks or so. I thought it was the way I sleep but it is gradually getting worse. It is beginning to radiate in my right wrist where my arm connects to the palm of my hand.
Breakthrough case admission after 4 vaccines Pfizer 2/1/21 Lot# EL9261;  Moderna 2/22/1 Lot# EL9267; MOderna 11/9/21 Lot# Ew0172;  Pfizer 7/21/22 Lot# FP7139
About 1 week after administration of Moderna vaccine, developed reddened, warm area just below injection site. Erythema was about the size of a half-dollar; not particularly painful but slightly tender.
Information has been received from a RN concerning 3 siblings who were vaccinated with varicella virus vaccine live. Two months later, they each experienced "25 fluid-filled lesions". Unspecified medical attention was sought.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had nine temperature excursions: 72 hours, 488 hours, 40 hours, 64 hours, 88 hours, 64 hours, 976 hours, 152 hours and 328 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 48 F (8.888888889 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Pt states left arm red swollen and sore. Advised to apply cold pack and take Benadryl if needed, If symptoms worsen, to go to ER.
pt recv vax 8OCT96 & became unresponsive for about 10sec then became alert;8OCT96 again devel sz like activity;
Autoimmune reaction to PNEUMOVAX 23 resulting in rheumatoid arthritis. I have been informed this is not curable and I will be on medications for the remainder of my life. On 10-24-12 I was given ZOSTAVAX.
Death; A spontaneous was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine and who died.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23-Jan-2021, prior to the onset of the event, patient received their first of two planned doses of mRNA-1273 (Lot number:013620A) intramuscularly for prophylaxis of COVID-19 infection.   On 25-Jan-2021, approximately 2 days after injection, patient Died. On 26-Jan-2021, neighbor Reporter called in to report a potential AE death. She shared that she lives in a condo building with other elderly. She shared that she and 2 other neighbors went to a vaccination site in Miami at a fire department. She shared that she is fine but that her neighbor died two days after shot. She shared that she didn't know if he had symptoms and that she knows that he had a lot of medical issues and was on about 15 medicines. She shared that she didn't know his age but guessed 70. She said we can contact his wife, but it must be a Spanish speaking agent because she speaks little English. She is concerned because they all received the vaccine at the same time. She wanted to reiterate that she was fine but believed we should know about the neighbor's death. No treatment information was provided.    Action taken with the second dose of mRNA-1273 in response to the event death is not applicable.   The patient died on 26-Jan-2021. The cause of death was not provided. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The cause of death was not provided.; Reported Cause(s) of Death: Unknown
Experienced flu-like symptoms; Developed a headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. In March 2022, 1 day after receiving Shingrix, the patient experienced influenza-like symptoms and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and headache to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient for herself.  The patient received Shingrix into the muscle of her left arm.  The first day following the vaccine, the patient experienced flu-like symptoms.  The patient developed a headache on the second day which she treated with Ibuprofen. Flu-like symptoms were resolved but she still had a headache which persisted.  The reporter did not give consent to follow up and to contact healthcare professional. The reporter did not have lot or expiration date.
Patient was sitting in observation area c/o being nauseous  and feeling a little dizziness. Taken to EMT room. States ice pack is helping her nausea. C/o feeling hot but does not want to take off sweatshirt.
15 YEAR OLD RECEIVED MODERNA ON 1ST VACCINE. IT WAS DISCOVERED WHEN HE CAME BACK FOR HIS 2ND DOSE OF MODERNA ON 5/19/2021
We believe with a highs degree of certainty that the patient received a full vial (5 doses) of undiluted Pfizer COVID vaccine that was not reconstituted.   S/S: Fever, Chills, Dizziness, Weakness, Lethargy for 2 weeks.
FIBROMYALGIA LIKE FLARE UP FROM  HEAD TO TOES TO FINGERS; TENSION HEADACHE; PAIN IN THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 23-JUL-2021, the subject experienced fibromyalgia like flare up from head to toes to fingers. On 23-JUL-2021, the subject experienced tension headache. On 23-JUL-2021, the subject experienced pain in the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fibromyalgia like flare up from head to toes to fingers, tension headache, and pain in the injection site. This report was non-serious.
Swelling started about the 3rd day after vaccination. The swelling spread down the upper arm to the elbow. It was warm, raised, itchy and sore.
Right after shot was given i had heavy bleeding that went down my arm. Now on day 3 of pain in left arm. Pain goes all the way to my knuckles and up into my neck. Also very bad headache that starts behind my eyes and then throughout my whole head. Feels like my muscle is tearing apart, so been up very late at night with pain.
dizziness,fatique, fever 104F lasted 2 days. Treated with ibuprofen/acetamenaphen Also had sore throat
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 69 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 28/40 which was not suggestive of malingering (<6). The patient was diagnosed with moderate mircosmia (16th percentile). The PEA (phenyl ethyl alcohol) test scores were -4.75 left, -5.25 right and -6.50 bilateral. The Whole-Mouth test identification test score was 62% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
Weakness when walking; Unusually unstable gait when she walks; Legs feel warm; Rest of her body feels cold; Not sure if she has a fever; Muscles are achy in her shoulder; Pain in the arm specifically around the injection point; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold) and PYREXIA (Not sure if she has a fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease. Concomitant products included CARBIDOPA, LEVODOPA (SINEMET) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in the arm specifically around the injection point). On 01-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever) and MYALGIA (Muscles are achy in her shoulder). The patient was treated with IBUPROFEN (ADVIL 12HOUR) for Pain and Fever, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (Weakness when walking), GAIT DISTURBANCE (Unusually unstable gait when she walks), FEELING HOT (Legs feel warm), FEELING COLD (Rest of her body feels cold), PYREXIA (Not sure if she has a fever), MYALGIA (Muscles are achy in her shoulder) and VACCINATION SITE PAIN (Pain in the arm specifically around the injection point) outcome was unknown.  Action taken with mRNA-1273 in response to the events was not applicable
Tongue feeling ?stiff? or kind of fat like at the dentist, tingling in face and nose, mild swelling in lips. Possibly minor flushing of cheeks, but since I had had a mask on, not sure.   Resolved after about 25 mins.
he had was a sore arm for 24 hours; heavy chills; This is a spontaneous report received from a contactable consumer (patient). A  male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EN6201 and expiry date was not provided), via an unspecified route of administration, in the right arm, on 14Feb2021 at 14:00  as a single dose for covid-19 immunisation. Medical history of the patient was reported as none. Concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine considered as suspect. Patient did not have adverse event following prior vaccinations. Patient did not receive other vaccine in four weeks of vaccination. No additional vaccines administered. On 14Feb2021, patient experienced sore arm (for 24 hours) and heavy chills (for 4 hour). Reporter seriousness for events were unspecified. No treatment was received. The outcome of events was resolved on 14Feb2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a 75 year old female who on 24-JAN-2007 was vaccinated IM with Pneumovax 23 (Lot # not reported). On 24-JAN-2007 the patient developed chills. On 25-JAN-2007 she developed a fever and the arm (NOS) she received the vaccination in became swollen. A day or so later she developed a rash covering her whole body except her face. She went to the ER, but was admitted. She had "every kind of test possible" (NOS). Subsequently, the patient reported that she recovered from the events 10 days after it started. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a 75 year old female with a history of osteoarthritis, diverticulitis, ischemia colitis, anxiety, osteopenia and no allergies who on 24-JAN-2007, was vaccinated IM into the right arm with a dose of PNEUMOVAX. Illness at the time of vaccination included left knee pain. On 25-JAN-2007 on awakening, the patient experienced right arm soreness, a mild temperature of 100 and progression to chills reported by phone 12 hours later. On 26-JAN-2007 the patient was seen in the office. It was reported that her temperature was 98.9. She had localized injection site reaction with mild erythema and moderate edema. She was also anxious. On 28-JAN-2007, the patient developed a fever of 102. She was sent to the emergency room where her temperature was reported to be 101.1. It was reported per the ER report, her skin was warm and dry. She had a diffuse macular pink rash over her torso and extremities. The patient felt awful. On 26-JAN-2007, laboratory diagnostic studies included a WBC of 12.2, Na level of 134. On 28-JAN-2007, in the ER laboratory diagnostic studies included a CBC and CMP. The patient stated she had every kind of test possible in the ER. Subsequently, the patient reported that she recovered from the events 10 days after it started. She was vaccinated with TETANUS and influenza virus vaccine (unspecified) in the past. No product quality complaint was involved. Additional information is not expected.
This spontaneous report was received from a registered nurse, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored dose of ROTATEQ (dose, frequency and route were not reported) lot # reported as M042169 with expiration date of 22-JUN-2018, for prophylaxis. The temperature of the ROTATEQ was between 9 °C and 25 °C for a time frame of 1 hour 27 minutes. No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of five reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA003158: US-009507513-1705USA003154: US-009507513-1705USA003150: US-009507513-1705USA003157:
Pt called stating two days after second Shingrix vaccine developed rash and redness on back and legs. Recommended to take Benadryl and have PCP or urgent care examine.
tightness in chest 2 hr p/vax; lasted approx 12 hr & resolved w/o tx;
t102 w/in 24 hrs, arm red & sore; dizziness & malaise sufficient to prevent working; not fully recovered when seen; took Advil-rest;
COVID vaccine breakthrough case Dose 1      Moderna       02/10/21        015M20A Dose 2     Moderna     3/10/21       044A21A Dose 3      Moderna      10/28/21       939904 Dose 4        Moderna     4/25/22           002M21A
Went home after vaccination and continued daily activities, went to bed with slight abdominal cramping. When I woke up to use toilet around 3:30am I discovered my right side of face was swollen and my right cheek was red [best described as looking like I just had oral surgery] but no fever. Took ibuprofen, and used warm compress, rested all day. Woke up next morning 02/04/2021 and face was fine.
Presents to ER for hypoxia and shortness of breath. COVID psotivie, admitted. Remdesivir, steroids, Vitamin suplementsSupplemental O2. D/C home on O2
13 days p/ vax pt exp 3-4 red, welts on arm, painful but no itching, pea size lesions @ inject site.
Simple Febrile Seizure; gurgling and spit coming out of mouth, open eyes but extremely "out of it", moaning and loss of most body functions, fever of 103.1 at ER at 2:50 PM, monitored fever and gave Tylenol and Motrin at the hospital, released at 5:15 PM