chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had flu shot and got sick from it; Initial information was received on 03-Oct-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 46 years old female patient who experienced she had flu shot and got sick from it after receiving influenza vaccine and treprostinil sodium [Tyvaso].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included alprazolam (xanax); vitamin d3; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (trelegy ellipta); oxygen; erenumab aooe (aimovig); omeprazole (Prilosec); montelukast sodium (singulair); naratriptan hydrochloride (naratriptan); rosuvastatin calcium (crestor); metoprolol succinate (toprol); amlodipine besilate (norvasc); and aspirin [acetylsalicylic acid].  On an unknown date, the patient started taking treprostinil sodium  (Inhalation powder dry) at a dose of 48 ug 4 times a day (QID) via inhalational route (batch number, expiry date, strength: unknown) for Secondary pulmonary arterial hypertension.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Influenza immunization. The information on the batch number will not be available.  On 09-Sep-2023 the patient had flu shot and got sick from it (illness)  (unknown latency) following the first and last dose intake of treprostinil sodium and (unknown latency) following the administration of influenza vaccine.  Action taken with treprostinil sodium (Tyvaso) was unknown and with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria: Hospitalization for event illness. The patient was hospitalized on the same day this event occurred and was discharged on 14-Sep-2023 (Duration: 5 days).; Sender's Comments: Sanofi Company Comment dated 10-Oct-2023: This case involves a 46 years old female patient who experienced she had flu shot and got sick from it after receiving influenza vaccine and treprostinil sodium [Tyvaso].  The patient had ongoing Pulmonary arterial hypertension. Further information on allergy history, family history, previous laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the limited reported information, the role of the individual suspect vaccine cannot be assessed.
9 x 9 cm area of erythema, warmth, induration, almost baseball size, palpable at site of vaccination reaction, chills, vomiting x 1, nausea.
arm very sore on lt side, bright red area on the lt shoulder w/a large knot;sore w/o being touched but very tender when touched;15DEC but still some redness;knot has dec in size;
This spontaneous report was received via company representative from a female patient of unknown age, regarding herself, who was a part of a Patient Assistance Program. Patient stated that she was having bad reactions to unspecified medications. Her relevant medical history was not reported. On an unspecified date in October 2013 the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot # unspecified). Concomitant therapy was not reported. Patient stated that she asked her physician to administer only half a dose PNEUMOVAX 23 to check how she would react and then decide if she would go back for the remaining the other half. She developed chills, fever, pneumonia and flu like symptoms (influenza like illness) the following day after receiving PNEUMOVAX 23. She also mentioned that these adverse experiences didn't last more than 24 hours. Causality assessment was not provided. Additional information is not expected, no contact details were provided.
Patient received pfizer covid vaccine at 1035. History of allergic reaction to insects and penicillins and sulfa antibiotics.   1110 Patient complained of uncomfortableness in throat area to pharmacist.    Pharmacist administered of 50 mg po.   1135 patient feeling better BP 124/82 with pulse rate of 84 and oxygen at 97%.    1140 patient feeling better sand understood risks of driving with benadryl on board. Patient has epi pen and understands how to call 911 if needed for further side effects of vaccine.
Headache, Myalgia, Fever, Diarrhea, fatigue Narrative:  Other Relevant History:
Fast heart beat; slowed breathing; intense headache; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; cant sleep; violently jerk; my face eyes nose itch bad for about 10 minutes and then go away; every muscle in my body hurts especialy my lower back/with muscles and lower back throbing; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration, administered in right arm on 19Jul2021 10:00, (at age of 54 year old), as dose 1, single for COVID-19 immunisation.  Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date. No known allergies. Concomitant medications included methadone, roflumilast (DALIRESP), Breztri all taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within 4 weeks prior to the COVID.  On 22Jul2021, 06.00, patient experienced fast heartbeat, slowed breathing, intense headache, every muscle in his body hurts especially his lower Back. He could not sleep, but 2 hours before, he woke up with muscles and lower back throbbing. Also, at the time of reporting, patient reported as he was sitting and watching tv, holding remote and out of nowhere he would violently jerk and his face, eyes, and nose itch bad for about 10 minutes and then went away. No treatment was given for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event face, eyes, and nose itch bad was recovered, where of all other events was not recovered.  Lot number/Batch has been requested.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about pertinent medical history and drug reactions/allergies was not provided. In 2018 (reported as in the last week), the patient was vaccinated with improperly stored VARIVAX lot # N029628, expiration date 23-OCT-2019 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported) with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to multiple temperature excursions between 6 degree Fahrenheit (F) and 14 F for a time frame of cumulative 155 hours without previous temperature excursion. Data logger was involved.
A little uncomfortable feeling after the first 2 doses; 2nd dose received more than 35 days apart from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included INFLIXIMAB (REMICADE) for Rheumatoid arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose). On an unknown date, the patient experienced FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days apart from 1st dose) had resolved. At the time of the report, FEELING ABNORMAL (A little uncomfortable feeling after the first 2 doses) outcome was unknown.            No treatment medication was reported. No lab data was provided.   This case was linked to MOD-2021-378141 (Patient Link).
Within 1-2 minutes of receiving the vaccine, the pt had decreased tone and perioral cyanosis / duskiness. The pt seemed very sleepy and lethargic. Symptoms completely resolved later in the day. On 10/8/99 he again received the vaccines, and again within 1-2 minutes had a perioral duskiness but no decrease in tone. Pt back to normal within 10 minutes. 3rd shot received was DT and experienced no reaction.
Mother stated she had hives in mid section that got worse with warm bath. Took her to private physican 2 days later. He said reaction was probably from immunizations.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA006323: US-009507513-1703USA006327: US-009507513-1703USA006325: US-009507513-1703USA006326: US-009507513-1703USA006322: US-009507513-1703USA006324:
Patient left message on 1/2/2021 reporting last two days has experienced fever of 101.4 - 102.0, muscle aches, joint pain, headache, fever, chills, tiredness, and feeling of unwell.
Chest tightness and shortness of breath with slight wheezing, chills, fever, body aches
After first shot 5 hours later, fast heartbeat, all my life never pounding fast like this, hand shaking, face hot and red, until 3 hours later heartbeat go down. 5 days later, my heartbeat go up to 140 and hand shaking , sweating, chest pain, shortness of breath. next 2 weeks, it happen 3 times per day heartbeat go up to 128, chest pain shortness of breath for 15 to 30 mins, sometimes 1 hr diarrhea for 2 weeks, stomach pain, bloating , heartburn, burping, dizzy, for 6 weeks
about 1/2 hrs p/vax pt started unconsolable cry which lasted 4 hrs-high pitched scream also accompanied the crying episode; about 2 hrs p/onset of cry, pt vomited x 2; mom noticed low grade fever present;
Information has been received from a male consumer concerning his 3 month old son with no past medical history and no known allergies who, in approx. 2001, was vaccinated with a dose of haemophilus b conjugate vaccine (+) hepatitis b vaccine recombinant (yeast). Concomitant vaccine therapy included diphtheria, poliovirus vaccine and other "required vaccinations". The child's parent was not certain as to what vaccines were given. According to the parent, within hours of receiving the vaccinations, the child started crying much more than usual and was also "spitting up more". The baby also seemed to be experiencing flu-like symptoms which were not subsiding. Additional information has been requested.
States that he had a temp of 104 while taking Tylenol on the morning after receiving his immunizations.  States he was lethargic, not eating well, and very sleepy.  Saw pediatrician who instructed mother to give tylenol and motrin alternating.  Fever broke around 24 hrs. after starting.  He returned to normal health.
As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got.   Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED.  They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form.  Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times.   And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene.  Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired.  Thanks for your time, and let me know if you have any questions.
No side effects until 6 hours after getting the booster.  I blacked out. My husband said I hit my head hard & was unresponsive for 2 minutes. I woke up to a bloody head and other marked symptoms for about two hours. My doctor told me I had a concussion. Was in good health, proper diet, and hydrated.
mild fatigue; mild body aches (legs); Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 13:00 (Batch/Lot Number: EL3247), at the age of 38 years, as single dose for covid-19 immunisation.  The patient previously took bnt162b2 on 04Feb2021 01:00 PM (at the age of 38 years), first dose, lot number=EL3247, in Left arm. The patient medical history was not reported. No other vaccine in four weeks.  No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication included ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM MULTIGUMMIES) taken for an unspecified indication, start and stop date were not reported.  The patient experienced sore arm on 25Feb2021 (about 6-48 hours after 2nd shot; peak arm soreness 18-36+ hours), mild fatigue on 26Feb2021, mild body aches (legs) on 26Feb2021 (beginning 18-40 hours after 2nd shot). The patient was not treated. The events were non serious with outcome of recovering.    No follow up attempts are possible. No further information is expected.
*Patient received FLUCELVAX and SHINGRIX on his right deltoid on 12/26/2018. Patient stated that he could not lift his arm up as high as the other arm with sensation of "locking up the muscle on his arm with ratiating pain to the hand. At night right after the shots, patient experienced fever, chills, and pain at the side of injection without swelling or redness. Then pain began to grow and stayed for 5 weeks. He described the feeling similar to carple tunnel syndrome with pain comes and goes, results in keeping him up at night.
Received pneumococcal 23 polyvalent vaccine Lot #5034299 (Merck & Sharp?) In my left arm on Oct 29 at 9am. At bedtime I felt some soreness but the vaccine site appeared normal. On Oct 30th about 3pm, I had a sudden onset of shoulder pain, difficulty moving my left arm, wave of body aches including at my extremities, shooting pain down both legs and a headache. On examing the vaccination site, the area around it, including the joint area, was red. There were also red streaks going with continuing sharp pains in my thigh area. I took 50mg of benadryl and an extended release tylenol 650mg and went to bed. The following morning the whole area appeared less inflamed. The redness/rash was still present in the area where the vaccine was given and in a separate area about 2 inches in diameter located on inside of the arm. The body aches and pain are gone. I continue to have a headache. Am a little tired but am able to function normally. I reported this to my doctor through the patient portal.
Expired vaccine given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatments were reported. It was reported that Expired vaccine given with no adverse reaction
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 40-year-old female patient who received FLUARIX (batch number 2SN22, expiry date 30th June 2016). On 20th November 2015, the patient received FLUARIX .5 ml. On 20th November 2015, less than a day after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX. Additional details were provided as follows: The patient experienced left arm soreness after the vaccination with FLUARIX vaccine. The nurse reported that the patient had planned to continue follow-up with the physician.
On 10/10/23 vaccine given at 5:12 PM to the LT deltoid muscle. Itching at the injection site started later that night. On 10/11/2023 it became noted warmth to the touch, redness, swelling, tenderness.
Pt informed me that she has experienced vertigo, nausea, and headache that started the morning after receiving the vaccine. Denies any fevers, vomiting, or syncopal episodes. Denies any local reaction at the site of injection besides mild soreness. No rash, itching or  shortness of breath. Pt has not taken any medications for the symptoms.
This case was reported by a pharmacist and described the occurrence of swelling arm in several patients who received FLUARIX quadrivalent. On an unknown date, the patient received FLUARIX quadrivalent at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX quadrivalent, the patient experienced swelling arm and limbs stiffness. On an unknown date, the outcome of the swelling arm and limbs stiffness were unknown. It was unknown if the reporter considered the swelling arm and limbs stiffness to be related to FLUARIX quadrivalent. Additional information: Several patients at the hospital indicated symptoms of swollen and hard arms after receiving QIV flu vaccine. Per representative, HCP was not sure which GSK vaccine.
Large, raised itchy hives (ranging from dime sized to larger than outstretched adult hand) covering majority of body, including hands and face, lasting for about 36 hours.
Headache day 1; Swollen axillary lymph nodes and in neck near clavicle day 2; Severe nose bleed which required being transported to ER day 3; Severe nose bleed Day 7; Severe nose bleed Day 8; Rash on lift side of face and neck Day 4.
I woke up with raised white bumps covering my arms, upper legs and behind. They were most pronounced on my thighs and behind but they also lightly covered by arms and torso. There were NO other symptoms - NO fever, NO itching, NO problem swallowing, etc. Just a lot of raised white bumps . My internist saw the pictures I took of it and thought it could be related to getting the booster vaccine.
Left arm of injection site sore, shivering at night, slight fever 37.4-37.7.
pt had a positive COVID test on 12/6/21 and was admitted to Hospital until 12/8/21 for AHRF; dc'd to home on O2 supplementation; Readmitted to hosp from 12/28/21 - 1/1/22 with acute on chronic hypoxic respiratory failure; initially treated for COPD, then IV Lasix; pt improved; had a follow up appoint in the clinic on 2/3/21 and was notable dyspneic and winded, but O2 tank was empty; replaced with full tank and O2 sats were in the 90s%; no acute hospitalization needed at that time; pt to RTC in 4 wks; per death certificate, pt died at home with causes of death being:  Heart Failure, A Fibrillation, CHRF, COVID 19 Pneumonia