chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called in the morning saying she is experiencing possible adverse  reaction from  vaccine she received yesterday. She said she is having two bumps on the same arm where received vaccine. It's not at the injection site but slighlty below. One bump was small while other one was pea-sized. She put cortisone cream and cleaned it with alcohol. I suggested her to apply ice also and see if swelling goes down. She said she will do it.   She called back again in afternoon and told me she has been doing combination of ice and steroid and redness and itchiness is going down but now there is a ring around the bumps. I told her to keep doing that combination and in case if it gets wrose then seek medical attention.
first shot years ago, late second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date about 5 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient reported that he/ she had received first shot about 5 years ago but never had the second dose, which led to incomplete course of vaccination. The patient enquired if they needed to start over.
This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion in the mind), TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 037C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Valsartan; Amlodipine [Amlodipine Besilate]; Atenolol; Omeprazole; Vitamins NOS for an unknown indication. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021, the patient experienced CONFUSIONAL STATE (Confusion in the mind). On an unknown date, the patient experienced TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away). At the time of the report, CONFUSIONAL STATE (Confusion in the mind), TINNITUS (Noise in her ears like "shh"), DIZZINESS (Dizziness when she moves), FEELING ABNORMAL (Brain fog) and FEAR (Fear that symptoms won't go away) outcome was unknown. Other Concomitant medications included unspecified medication for high blood pressure in the morning, Vitamin for bone, unspecified medication for heartburn acid and unspecified eye drops for an unknown indication. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up document received on 19-JUL-2021. Updated events and concomitant medications. On 06-Aug-2021: Non Significant Follow-up.
Patient is 16 years of age and had previously received the initial dose of Moderna  Covid-19 vaccine from the Health Department. She presented to our pharmacy for second dose. We observed that she received the incorrect vaccination for her age. After consultation with her mother, physician and our vaccination coordinator, it was decided to administer second vaccine.
Information regarding Orimune Vaccine (poliovirus vaccine live oral trivalent solution) (manufacturer unknown) was received from an attorney regarding a male patient who experienced mesothelioma. The patient received a dose on an unspecified date sometime during 1959 or in the early 1960's. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On or about 3/02, the decedent was reportedly diagnosed with mesothelioma. The decedent's history included exposure to asbestos and asbestos-containing products. The legal complaint states that the decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 1/27/03, he died. The death certificate received on 2/19/04 states respiraotry failure, pleural effusion and pericardial effusion.
SUSPECTED CLINICAL VACCINATION FAILURE; MINIMALLY SYMPTOMATIC SARS COV 2 INFECTION; This spontaneous report was received from literature: This report concerned a patient of unspecified age, sex, race and ethnicity. 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, batch number: Unknown and expiry: Unknown) dose,1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, Laboratory data included: Enzyme-linked immunosorbent assay and neutralizing antibodies revealed breakthrough SARS-CoV-2 infection. Patient had minimally symptomatic SARS-CoV-2 infection (between days 71 and 239), and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minimally symptomatic SARS-CoV-2 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: 20210905584-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This case was received from a health care professional on 13 March 2009. A 17-year-old male patient, with a one-week history of upper respiratory infection, received an injection of MENACTRA on 11 March 2009 (lot number, site, and route of administration not reported). Shortly after vaccination, he developed angioedema, urticaria, and pruritis. He was treated with an antihistamine and DECADRON. At the time of the report, the events remained ongoing. The patient had no known allergies, and no medical conditions. Concomitant medication included FIORICET.
PT HAD DEVELOPED RASH UNTIL HER ELBOW ALL AROUND THE ARM AND WAS INF LAMMED FOR 3 TO 4 DAYS
pt states 1hr p/vax chills/fever disorientation, nausea, felt like someone hit pt on head w/baseball bat;h/a;
Mom State the patient got up in AM and stated he had chills most of the night. Temp was 100.7,Dizzyness,heasache and vomiting.
Pt vaccinated with DTP/OPV/PRP-D on 6PCT90. @ 1:00 pm 7OCT90 child had uncontrolable crying & woke them up with a piercing scream. On 6OCT90 PM chil had fever & was lethargic.
approx 10min p/vax mom noticed tremors of the head & arms;eyes were half closed;pt was taking a bottle;mom told to wake pt up, pt woke up & the tremors stopped;only lasted 10-15 seconds;
Client call and voiced that he wanted to "report a reaction". States that his left arm became very red/discolored and had rash all below the injection site. States that he had severe pain with this as well. States that these things began about 24 hours after immunization. Client does state that the pain has ceased, the redness/discoloration is fading, and the rash is resolving as of this morning 3/2/2020.
Information regarding PREVNAR was received from a pediatrician regarding a male patient who received the fist dose on an unspecified date at the age of 2 months. At the age of 3.5 months, the patient was hospitalized for pneumococcal meningitis. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, at the age of 2 months, the patient received the first dose of PREVNAR. At the age of 3.5 months, the patient was hospitalized for pneumococcal meningitis (drug ineffective). On an unspecified date, the patient recovered. Serology test (results: unknown) was done on an unspecified date. No additional information was available at the time of this report.
I had muscle and joint pain in my upper arms and legs. It was very much of a tightness. I was foggy brained and very tired. I slept a lot. I took TYLENOL and ADVIL. I had to stop exercising, I swim and lift weights and had to stop the activity due to the fatigue and pain. I can just walk a little now. I could not lift my legs or put my arms over my head. This all started two days after the vaccine. I went to the ER five days later, and then the next day I saw a NP. In two weeks, I see the PCP and receive a diagnosis of Polymyalgia or PMR. I started taking prednisone on Friday, and the pain has been relieved. My mother and uncle have gotten this same diagnosis. I am not sure if there is any connection.
This spontaneous report as received from registered nurse refers to a 25 year old female patient. Patient had no previous medical history and drug allergies. On 07-OCT-2013 the patient was vaccinated with GARDASIL injection lot # J007354 with expiry date 20-FEB-2016, 0.5 ml, intramuscularly. Concomitant therapies included unspecified birth control. On 11-OCT-2013, 4 days after receiving GARDASIL the patient developed a sore arm. On 11-OCT-2013, patient notified nurse via phone and no treatment was given. No laboratory tests were performed. The outcome of sore arm was unknown. Additional information has been requested.
local redness at site of DTaP inj. warm to the touch 3: diam. at inj. site itchiness (L) arm.
I had a delayed reaction. So at two weeks, I broke out with hives either April 20th or 21st, on the 24th it got really bad. I went to an urgent care center and advised to watch the symptoms. I took Zyrtec, Benadryl and topical stuff for itchy skin. As of today, I still have itchy spots. COVID-19 positive on July 17, 2020, January/February 2021, again in 2022 (date unknown).
From July 24,2006 to Aug 5 2006 had bas pain and swelling all around arm and down the arm to elbow. Deep redness all week and warm. Had to stop using arm all this time, had nurse at cardiac rehab fitness program check arm 3x a week. Treatment of ice and Tylenol every day. No use of arm at rehab. Nurse called Doctor to check arm on 8/28/06.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown demography. The patient's medical history and concurrent conditions were not reported.. On unspecified dates, the patient was vaccinated with dose 1, dose 2 and dose 3 of GARDASIL by different healthcare provider. On an unspecified date, the patient inadvertently received a fourth dose of GARDASIL (extra dose administered). No symptoms were reported. The outcome of the events was unknown. Additional information has been requested.
Pt came to PRIVATE to receive menactra and first dose of covid 19 vaccine.  Pt was given injection  was t alking  with nurse and parent when she became pale  started gag like motion like she was going to vomit.  Pt  seated in chair  then passes out loses incontinence of urine.  Vitals are taken, at parent request 911 activated  pt is out approx 5- mintues.  Pt regains  consciousness  pt states she is confused.  Pt vitals  monitored  pt is alert to name place DOB .  EMS arrives pt walks to cot and is transferred to local hospital per parent request.     Vitals 14:15 Resp 12  unlabored BP 97/72            14:20 Resp 14 unlabored  BP 102/78
This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date and route were not reported)  for prophylaxis. On an unknown date post administration, the patient had two trips to Emergency Room (ill-defined disorder). At the time of the report, the outcome of ill-defined disorder was unknown.  The reporter considered ill-defined disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The patient also mentioned that she seemed to have a reaction to every vaccine she got.
Fever hit 103, I had intermittent nausea, a migraine so bad it made my teeth hurt??.but by far my worst side effect was that every bone in my body felt like it was about to break or broken. My skeletal system hurt so bad, no matter if I was laying in bed?.I got no sleep, if I stood up, my hips and knees felt like they?d been in a car accident. I could not find a bearable position to be in for almost 20 hours. I wanted to die.
itching; Swelling at the injection site; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE SWELLING (Swelling at the injection site). On 25-Jan-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Patient received vaccine on 13 Jan 2021 on right arm between his elbow and shoulder. He saw the doctor, who gave him a steroid for the reaction and some form of penicillin, but he doesn't think it's penicillin. He was still currently taking them up until today 25 Jan 2021. Within 30-45 minutes of taking both on 23 Jan 2021, the itching stopped and the swelling started to reduce a bit.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI
Developed rash on the morning  of 7/14 that spread all over body throughtout the day.
The patient received his vaccine on Monday 2/1/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 99.1 F. Since the patient was febrile, he was given rapid COVID tests, which was negative. Patient was not in distress.
Patient received his 2nd dose of Pfizer on 1/6/22 at Pharmacy  Late Thursday, early Friday, patient developed low grade fever, intermittent diarrhea, body aches, fatigue, sore throat and possible cough. Day 4 and still with symptoms.
it was rpt fr MD concerning pt who was exposed to son who was vax & on 24oct98 the pt exp possible secondary transmission & devel chickenpox
My left leg, especially my foot, I have been experiencing some really bad neuropathy in it; Little bit of neuropathy in my left foot; I got my booster shot about five or six days ago; This is a spontaneous report from a Non contactable consumer (patient, self-reported). A 58-year-old patient of an unspecified gender received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as unknown, a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient didn't really have a phone number right now, anyway the patient just wanted to ask, the patient got booster shot about five or six days ago. The first two shots, the patient didn't have any problem at all and right now, from the past two days, the patient got the shot on left arm and the patient did not know if this has any correlation but the patient's left leg, especially my foot, I have been experiencing some really bad neuropathy in it, just like 'nothing (voice breaking) in my foot'." (Shot name not clarified, hence suspect captured as Unspecified Shot and is this a Pfizer product tab left unchecked). When paraphrased the concern, the patient stated, "Yes, little bit of neuropathy in my left foot. The patient had a little bit of neuropathy from the past few days since I got it." Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Lt arm bruise w/bilateral macular papular rash on arms starting 3 days p/lasting approx 10 days. Diarrhea x 2 days.
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). The patient's medical history included Constipation. The patient's concurrent disease(s) included Encopresis, Vesicoureteral reflux and Otitis media. Concomitant medications included Amoxicillin and Macrogol. FLUMIST QUADRIVALENT (Intranasal) started on 03-Dec-2013. The patient was inadvertently administered expired FLUMIST QUADRIVALENT on 03-Dec-2013. The outcome of the event of Inadvertently administered expired FLUMIST QUADRIVALENT to a patient is unknown. The report was considered to be non-serious.
Could not move; Fever with temperature 101.5F; Body was aching like crazy; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy). At the time of the report, MOBILITY DECREASED (Could not move), PYREXIA (Fever with temperature 101.5F) and MYALGIA (Body was aching like crazy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Body temperature: 101.5 (High) 101.5 Fahrenheit.         No concomitant medication was reported by reporter.  Patient took second booster of Moderna on 01-Apr-2022. Patient did not take any treatments for side effects.
Was given a Hepatitis A in left upper arm and HPV injection in rt upper arm on April 19, 2013 Friday. On Sunday she developed a rash on right arm, fever 102 degrees, vomiting, sore throat, swollen gland rt side of neck.
After receiving 2 IM injections in each arm the patient became pallid and had a syncopal event. The event lasted less than one moment and was self limited -he woke without any intervention. He had a very brief period of confusion and then was back to baseline neurologically prior to discharge home.
After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; After the first dose, slight nausea, subsided after a few hours.After second dose, solid pain in upper half of body and numbness in both arms. Discomfort last for 24 hours after shot.Since the shots; menstruation cycles have been significantly heavier; closer in frequency; more discomfort than usual; On 02Apr2021, the patient received second dose and first dose; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient (consumer) received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (age 50-year-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Batch/Lot Number: EW0150, age 50-year-old and non-pregnant at the time of vaccination) as DOSE 1,SINGLE for covid-19 immunisation. The medical history included allergy triggered asthma from an unknown date and unknown if ongoing. The concomitant medication included levocetirizine dihydrochloride (XYZAL, other medications taken in two weeks included Xyzal) taken for an unspecified indication, start and stop date were not reported.  The patient previously took zithromax and experienced allergies. No other vaccine taken in four weeks. On 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered). After the first dose, the patient developed slight nausea, subsided after a few hours on 23Apr2021. After second dose, solid pain in upper half of body and numbness in both arms on 23Apr2021. The discomfort lasted for 24 hours after shot. Since the shots, the patient's menstruation cycles have been significantly heavier, closer in frequency (3 weeks instead of 4) with more discomfort than usual on 23Apr2021. Considering that the patient was 50-year-old, her periods were slowing down since 2018. The patient did not receive any treatment for the adverse events. No covid happened prior to vaccination. The covid was not tested post vaccination. The outcome of the events was recovering at the time of report, while outcome of the event on 02Apr2021, the patient received second dose and first dose (Inappropriate schedule of vaccine administered) was unknown.
Dose was administered 60hours after the vial was punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered 60hours after the vial was punctured) had resolved.        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.   Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Unknown)  with no associated AEs.