chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was in absolute agony; Pain in my shoulder like shoulder to shoulder; kind of flaring on and off for a few weeks; Pain in arm; Pain in leg; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that patient had a serious side effect. The patient had the Pfizer Vaccine (Unspecified Vaccine) three weeks ago (Aug2021). 36 hours after (Aug2021) the patient had the vaccine, patient woke up with 'flaring' pain in the shoulder like shoulder to shoulder. The patient was able to make it through the night with pain medication and that were (word not clear) kind of flaring on and off for a few weeks. On Saturday night which was Saturday afternoon 'three' and a half week after the patient got the vaccine, in Sep2021, it flared up again, the patient was in absolute agony 'because nothing' (Not clarified over the call) had ever been neurotically in patient life (Further clarification was unknown) and the patient had to go the hospital. The patient was given high dose IV steroid and pain medication (treatment) and now on lower dose steroid (intent: treatment) and the patient was still having the pain (Further clarification was unknown). So, just wanted to report the side effect that cause the patient had to go to the hospital and speak to someone in United States rather. The patient had concern about both shoulder, not just one, both but other symptoms as well, pain in arm, pain in leg but the really bad pain was in both shoulder (on an unspecified date in 2021). Outcome of the event shoulder pain was not recovered; other events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient reported having shoulder pain and decreased mobility that began around the day after receiving the flu vaccine. Patient denies having pain while receiving vaccine and location of vaccine is within the appropriate deltoid region of the arm. Patient is still experiencing pain and decreased mobility in shoulder while trying to move arm in certain directions. Patient has slowly gained some of the lost mobility while trying to take NSAIDS. I advised patient to add heat therapy and also to see MD about possibly starting physical therapy/further care. This is the first time patient has ever received the flu vaccine therefore an immune/allergic response could be causing the bursitis too.
From initial information received on 22/Aug/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 15-year-old female patient received TD ADS adult, lot number U0838AA, administered in the left deltoid on 18/Aug/2003 at 10:00 am. Later that day, the patient developed a large, golf ball-sized swelling with a bruised appearance at the injection site. The patient also experienced a headache, stiff neck and aching all over. The patient had not recovered at the time of this report.
High fever 102. Gave 2 Motrins. 6:00PM temperture spiked to 104.8 gave another Motrin. Brought temperature down to 101.8. Linger at that temperature for 48 hours giving 3 Motrins every 6 hours. Lethargy, weak and pale from 3/14/2011 on. Developed a cough which got progressivley worse over time, fever off and on. 3/21/2011. dx. bronchitis with rales in lungs. Treatment: azithromycin for 6 days. 3/28/11 back to doctor, no change in patients status. Treatment Albuterol in doctors office- no change, chest x-ray neg for pneumonia. Treatmet albuterol for 5 days and predisone for 3 day. Stopped albuterol when I realized it may be a reaction to the chicken pox vaccine.
Information has been received from a physician and a Licensed Visiting Nurse (LVN) referring to multiple unspecified patients. The patient's pertinent medical history and concomitant therapies were not reported. On unspecified dates, the patients were administered improperly stored ZOSTAVAX (dose, frequency and route of administration were not reported, lot # L021608, expiration date 10-SEP-2016). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Patient described a rash in midsection plus both arms beginning the evening after administration. Began fading within 24 hours. Patient contacted his doctor. Tried BENADRYL for symptoms. Trending toward full recovery.
Patient presented to the ER in a coma and was diagnosed with a ruptured cerebral aneurysm.  There is no report by family of post-vaccination symptoms prior to the aneurysm rupture.
Developed cold sores after receiving the shingles vaccine. About 3 weeks after getting the shot.
Error: Second Vaccine given on 21st Day rather than on 28th Day. No adverse event
Woke up with numbness and tingling on left side of top of head, forehead, left eyebrow, left eye, L nostril and L upper lip and L upper teeth which has remained for since March 24, 2021 onset. Seeing Neurologist on May 17, 2021
Pt received a flu vaccine and a covid vaccine in separate arms on wednesday 10/12/22.  Zero reaction with flu vaccine but she woke up to soreness, a small red rash/area that was radiating heat and a little swollen on the other arm. It progressively got worse throughout the day. When she stopped by on friday the 14th the area was still warm to the touch, swollen and red.
24 hrs after ZOSTAVAX - developed herpes zoster L ant chest, near arm.
Area to left upper arm red, swollen, warm. Area approx 4.5" in length. C/o tenderness to area, less today than yesterday. Able to move arms diff. Return for exam today. Seen Dr., Dx cellulitis. Rx with Keflex.
Complains of soreness with direct pressure or palpation to left arm.  Pain shoots into left lateral neck only with palpation/pressure to injection site. Pain in arm started during night of injections.
In May of 2021, I discovered a cysts about the size of an almond in my right breast so I contact Dr. to schedule a mammograms and MRI  for June 1st, 2021. The results came back negative for cancer.  Still to this day I still have the cysts in my right breast.
EXTREME FATIGUE AND BODY ACHES / BONE PAIN LASTING LONGER THAN 3 WEEKS.   COMPLETELY BED-RIDDEN, LOST OF APPETITE, EXTREME LEG / BONE PAIN.
Wheal and raised rash at injection site. Significant pain at injection site, Hardened area palpated subdermal.
On the car ride home within a 1/2 hour left side of face started numbing and it comes and goes ever since the date of vaccine.   It goes down to the lips.  There is pain associated with the numbness and it's concerning it hasn't gone away.   Went to internist today who said he wasn't comfortable with this outcome and suggested calling Neurologist.  Waiting on appointment.
Starting in the evening of the day I got the shot, I started feeling very achy and was chilling.  By the next morning I had a headache across the lower back of my head that was bad enough that I felt sick to my stomach and didn't want to eat and had some light sensitivity as well.  I still had the achiness and chilling but did not have a fever when I checked.  All I could do until late afternoon was sleep off and on - I didn't even feel well enough to read or watch TV.  The injection site was red, bumpy (like hives), hot and sore.  By the morning of the second day after the shot I felt well enough to work.  I still had a slight headache but Tylenol seemed to help.  I didn't have much of an appetite and the injection site was still red, hot and sore.  By the third day I felt more or less normal except for the injection site.  The redness and soreness was not totally gone until the 5th day after getting the booster shot.
On January 2nd  2022, developed a sore throat which developed to severe body ache, headache and further into chills and severe chills on January 3rd. Chills subsided on January 4th, cough began developing, mucus discharge from nose, general fatigue and exhaustion set in. The January 4th symptoms progressed until January 9th, when mucus discharge abated. Cough intensity had reduced by this time, but persisted. Attempts to resume normal activities increased cough intensity and caused difficulty breathing. Cough continued to gradually abate until Week of January 23rd.
Moderna COVID-19 Vaccine EUA;   strong body aches, diarrhea, chills, fever (101-102) for two days following the vaccine.  Symptoms went away after the end of the second day.  Vaccine administered on Thursday,  began with the fever early Friday along with all symptoms mentioned previously and continued until the end of Saturday.  Sunday morning symptoms no longer present with the exception of the arm where the vaccine was injected was still hot and in pain.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Taking blood pressure medication ongoing" (ongoing). The patient has no known allergies. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Sep2023) positive, notes: Tested positive morning after completing five days of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
immediate swelling of injection site into a hard ball. had caregiver immediately apply ice pack to patients arm
For 2 days after receiving my first Covid-19 Moderna vaccination, I had a sore arm with redness and warmth at the injection site.  Sometime on April 3rd I began to experience slight itching at the injection site.  I did not notice redness at the site at that time because I itched the area before I looked at my arm.  There has been slight  pruritis at the same area since.  Today, April 7, I noticed a 4cm rounded pink area at the injection side with slight warmness.  The pink area still itched.
headache, fever, chills, fatigue, body/muscle aches and pain, chest pain, bronchitis type breathing, difficulty swallowing
14 hours after getting the final dose of Moderna, I experienced chills, headache, body aches and a very bad back ache, along with general fatigue.  Symptoms lessened as the day went on and by the next morning (about 40 hours after the shot), symptoms were pretty much cleared.
Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their policy is to wait until after second dose).  The day after vaccination,  patient was complaining of fatigue with subjective fevers and rigors with associated headache and neck stiffness and on the day of presentation he complained of increased fatigue and general malaise for which he left work early and was ultimately found poorly responsive in his private vehicle with concern for possible seizure activity.  He was brought to ER by ambulance.  He reported numbness in hands and legs, rigidity, and an episode of urinary incontinence.  He was started on empiric antibiotics for possible CNS infection, lumbar puncture completed. Found to have acellular CSF and antibiotics were discontinued.  Patient remains in hospital at this time with course complicated by post-LP headache.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 06-JUN-2015 was vaccinated with an improperly stored of GARDASIL lot #K006960 as (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent an unknown an unknown number of excursion hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Pt came in with mother for Tdap, Varicella #2, MCV4, HepA and intranasal influenza (FLUMIST) vaccines. Mother denied any reactions to previous vaccines, allergies to food or meds or child being ill today. The mother was advised child (13yo) would have to sit and be observed for 10-15 min. Mother agreed. Child given vacs and went to bathroom then sat down after 10 min I asked child to stand, she wobbled and said she was dizzy. Took child to lay down. Observed child for 1 hr - sent home.
migraine with aura attack at around 5pm start; finger numbing - moving through fingers around 6-6:30pm to around 7pm; tingling fingers and hand up until now at 12:30pm on 10/19/23; continued headache until now; fatigue and slight dizziness at times
This spontaneous report was received from a nurse, via a company representative; and it refers to a male patient that, according to the reporter was 11 or 12 years old at the time of event. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided. On approximately 29-MAY-2015, reported as 2 to 3 years ago, the patient was vaccinated with 1 injection of GARDASIL 9, for Human papillomavirus (HPV) prevention (dose, route of administration, lot number and expiration date were not reported), and that immediately after receiving the GARDASIL 9 injection, the boy develop a rash all over his body (Rash generalized), for what the vaccination center personal sent the boy to the neighboring hospital for treatment. The nurse reported that the patient recovered (date was not provided), but was contraindicated to receive further doses of GARDASIL 9. It was also reported that the event did not represent a significant disability or incapacity for the patient, and there was no patient overdose involved. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the Rash generalized.
she is 10 days out from her vaccination and she is still not ok and is feeling worse; Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it; can hardly move my right hand/ not able to move my body properly; feeling "pins and needles" in her feet and fingers; stiffness; I have tingling in my fingers and toes; entire body was hurting; severe pain; Her pain is worse in her hands and feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Sep2021 (Lot number: FF2588) at the age of 29 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MOVEMENT DISORDER (non-serious) with onset 10Sep2021, outcome "not recovered", described as "can hardly move my right hand/ not able to move my body properly"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "feeling "pins and needles" in her feet and fingers"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Sep2021, outcome "not recovered", described as "stiffness"; PARAESTHESIA (non-serious) with onset 10Sep2021, outcome "not recovered", described as "I have tingling in my fingers and toes"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "entire body was hurting"; PAIN (non-serious) with onset 10Sep2021, outcome "not recovered", described as "severe pain"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands and feet"; PAIN IN EXTREMITY (non-serious) with onset 10Sep2021, outcome "not recovered", described as "Her pain is worse in her hands/ her right hand as being the absolute worse, to the point she cannot do anything with it"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is 10 days out from her vaccination and she is still not ok and is feeling worse".  Additional information: The patient was in severe pain for the past 9 days on 10 days. There was no investigation assessment done.  Follow-up attempts are completed. No further information is expected.
Pt. received vaccines at clinic about 45 minutes later developed hives - mom called clinic informed to give 2 tsp BENADRYL and brought back to clinic.  Taken to ER in a wheelchair.
Several minutes after patient receiving pfizer vaccine. Patient became nauseated, vomited, experienced clamminess and near syncopal episode but asked for help when started feeling bad. Patient removed from main observation room to one on one monitoring. Patient rested and ate. Patient did not need further intervention. Vital signs stable. Patient picked up by boyfriend and driven home.
administration of 5mL IPOL to a patient instead of the 0.5mL standard dose with no reported adverse event; Initial information received on 15-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient who had administration of 5ml IPV (VERO) [IPOL] instead of the 0.5ml standard dose with no reported adverse event  The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines were taken by the patient.  On 15-Jun-2023, the patient received a dose 1 of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot V1B901M) (with an unknown strength and expiry date) via unknown route in the right thigh for Immunization with dose 5ml total instead of the 0.5ml standard dose with no reported adverse event (incorrect dose administered) (latency- same day)  Reportedly, Medical assistant (MA)called reporting one of the nurses at the doctor's office injected the full 5mL IPOL to a patient instead of the 0.5mL standard dose. MA wanted to know what to do next, what is going to happen with the patient, and if there's something they should monitor?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (infrequent). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) and DOCUSATE for an unknown indication.    On 15-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 15-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 15-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Amniocentesis: normal (normal) Normal. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Past pregnancy details included: Live birth on 20 Apr-2018.
hepatitis B nonresponder; Literature Report:  This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 47 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 48 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
No additional AE reported; Nurse reports a 10 months 4 days old patient was accidently administered ROTATEQ on Nov 15, 2022.; received the last dose of ROTATEQ later than suppose too; This spontaneous report has been received from registered nurse referring a 10 months 4 days patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-NOV-2022, the patient was accidentally administered with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, once, lot number W002562 with expiration date 12-OCT-2023 (strength, vaccination scheme, route of administration and anatomical site of application were not provided) (inappropriate schedule of product administration, product administered to patient of inappropriate age). No additional adverse event reported.