chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports body itching and redness in face and hands. Allergic reaction was after 15 minutes approximately after the vaccine administration. She received BENADRYL by mouth and was sent to emergency department. We were communicated with patient and she reported she was treated with Solumedrol and BENADRYL by vein. Oxygen was given because her saturation was at SPO2% 92 she was there from 9:50am and approximately at 2 pm discharged.
Due to my IUD, have not had a period in 2 years (PMS symptoms are minimal too). On 4/25, I woke up with horrible cramping and nausea. I was irritable, in pain, and needed to use feminine products for the first time in years. Since this vaccine, I have had spotting and cramping randomly. This did not happen pre-vaccine. No treatment known (other than removal) that is preferable. Slowly this is going back to normal but still having random days of spotting.   Filing a report in case there is a reaction found between hormones (birth control) and vaccine ingredients.
This case was reported by a consumer and described the occurrence of feeling unwell in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sickness. The reporter stated the SHINGRIX vaccination was beyond worth to be protected from the shingles. The reporter could not be contacted. This case is 1 of 4 cases, reported by the same reporter.
Pain in (L) elbow and swelling of (L) hand reported by patient. Pt stated occurred soon after vaccination. Did not report any ADR's until 2/1/17.
Loss of sight in my right eye. First thought to be Optic Neuritis but not sure now
About 12 hours after receiving Shot 2 of the Moderna vaccine, I had about a 15 minute window of thinking I wasn't feeling good.  Then chills and body aches hit me like walking into a wall.  This lasted 48 hours with periods of it being worse than others.  I took Tylenol every 4 hours pretty  much around the clock during this to curb the symptoms.  After the chills and aches ceased, I had a headache off and on for the next 24 hours.
swollen lymph nodes after vaccination; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain; Right arm bicep muscle is so sore and is a hard knot; the muscles if you were going to make a muscle is very sore and hard/If I try to lift something too heavy, its excruciating pain; the day I got the shot, my hand became a little weak; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 21Dec2020, Stomach problem, Acid reflux, fatigue felt tired , little fever , historical allergies, Neuropathy , High blood pressure. Concomitant medications included atorvastatin; gabapentin for neuropathy peripheral,; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication. The patient previously took codeine and experienced she almost passed out, demerol and experienced she almost passed out. It was reported arm that received the injection, "the muscles if you were going to make a muscle is very sore and hard". Caller says this is not the same area/muscle that the injection was given. the day I got the shot, my hand became a little weak. It went away. "Caller also says she had covid infection in Dec2020, This consumer was administered her first dose of Pfizer COVID-19 Vaccine 10Feb2021 at (Facility name). She had no problem whatsoever until 16Feb2021. Starting 16Feb2021 her right arm bicep muscle is so sore and is a hard knot; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain. She has no fever. She cannot get ahold of her doctor because their office is closed today due to the weather. She called to ask about these events; if she should put ice or heat on the affected area; how many Tylenol she should take for this. She initially reported that the affected area is the area of the muscle that you make, not in the backside muscle where the Pfizer COVID-19 Vaccine injection was administered; affected area is the front muscle, bicep that tightens when you flatten your hand forward and curl upward with the lower arm. If she raises her right arm up so far it's very painful, but not so painful that she cannot stand it. She also developed swollen lymph nodes after vaccination. Therapeutic measures were taken as a result of right arm bicep muscle is so sore and is a hard knot (muscle swelling), the muscles if you were going to make a muscle is very sore and hard/if i try to lift something too heavy, its excruciating pain (myalgia), the day i got the shot, my hand became a little weak (muscular weakness), if she accidentally picks up something or tries to pull on something with right arm she has excruciating pain (pain in The outcome of the event Swollen lymph nodes; Muscle pain; was unknown; Pain in arm; Muscle swelling was not recovered; Hands weakness of was recovered;
Left arm ached and was sore; Extreme shortness of breath; No appetite; Had a fever of 99.7; Fatigued; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm ached and was sore), DYSPNOEA (Extreme shortness of breath), DECREASED APPETITE (No appetite), PYREXIA (Had a fever of 99.7) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Pyrexia: 99.1 (abnormal) 99.1.     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.   Concomitant medication was not provided by the reporter.
Redness, swelling, and feverish at the site of injection. Cellulitis.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral liquid, lot# K023537, expiration date 22-JUN-2016 (dose not reported). No information on patients' concomitant medications was provided. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
FEELING SPACY; This spontaneous report received from a consumer concerned a female of unspecified age ,race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2 s (unspecified manufacturer) (suspension for injection, route of admin was not reported, and batch number: unknown ,expiry: unknown) frequency one total, dose was not reported for prophylactic vaccination. It was unknown whether the patient had any adverse events. (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number: unknown ,expiry :unknown) frequency one total, dose was not reported, administered on 02-DEC-2021 for prophylactic vaccination (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-DEC-2021, the patient experienced feeling spacy.  reporter stated that after vaccination of booster dose patient felt little spacy at night, at the time of reporting she was better. (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling spacy on DEC-2021. This report was non-serious. This case, from the same reporter is linked to 20211222743.
Stomach cramping; Grogginess; Headache; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.     A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955), an unspecified route of administration, administered in right arm on 16Mar2021, at 14:45 as single dose for covid-19 immunization at the age of 53 years old.  Medical history included sulfa allergy. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  The patient experienced stomach cramping, grogginess and headache on 17Mar2021, at 08:00.  The events were reported as severe stomach cramping started the next morning, followed by a headache and grogginess. No treatments were given for the events. The clinical outcome of stomach cramping, grogginess and headache was recovering.
This is a spontaneous report from a contactable physician, received via a Pfizer Sales Representative. A female patient, age: 18, unit: unknown, receive TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, after vaccination, the patient experienced extreme redness, swelling, high fever at body temperature 103, nausea and extreme irritability. The outcome of the events was unknown. The information on the batch number has been requested.
Pt received vaccination at 0955. At approximately 10;15 another patient came over to the admin desk and notified us that pt wasn't doing well. I went over to evaluate and pt told me she felt fine and she would take a Benadryl when she got to the car. I assisted her to the back where we further evaluate her. She had clear signs of anaphylaxis (blood shot eyes, hives, swollen tongue, rapid heart beat) but did not want EPI. I advised her that EPI is NEEDED quickly and that Benadryl was not enough. She then agreed to let me EPI her. Epi was administer in the left thigh at 10;18. A set of vitals were then taken and patient was places on o2. The emergency department was called at 10;20 and arrived at  10;25. During this time another set of vitals were taken. Patient expressed feeling better but jittery.  Hives and tongue swelling had significant improvement but patient still had some symptoms so we advised the follow up team of our recommendation for second dose epi. Emergency team took control of patient.
The caller´s wife came into the call and said that his mother had died after receiving the Moderna vaccine back in 2020.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (The caller´s wife came into the call and said that his mother had died after receiving the Moderna vaccine back in 2020.) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Dosage text of Moderna COVID-19 Vaccine was reported as unknown. No treatment medication details was reported.  Company comment:  This spontaneous case report concerns a 97-year-old female patient with no medical history provided, who experienced serious (due to fatal outcome and medical significance) unexpected event of Death. Reportedly, the patient died on an unknown date after receiving unknown dose of the mRNA-1273 vaccine. Temporal relationship between fatal outcome and vaccine administration remained unknown. The exact cause of death remained unknown and it also was not known whether an autopsy was performed. The patient's elderly age remains a confounder for the event. The reporter denied further contact. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714122, US-MODERNATX, INC.-MOD-2023-714201 ( Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714122: US-MODERNATX, INC.-MOD-2023-714201:; Reported Cause(s) of Death: Unknown cause of death
Information has been received from a registered nurse concerning an approximately 8 week old patient with no pertinent medical history and no known drug allergies/reactions who on 13-APR-2009 was vaccinated with the first PO standard dose of ROTATEQ.  Concomitant therapy included PEDIARIX, ACTHIB and PREVNAR.  On approximately 14-APR-2009 ("24 to 48 hours after the vaccination") the patient experienced diarrhea.  No lab diagnostics studies were performed.  At the time of reporting, the patient's diarrhea persisted.  The patient sought medical attention via seeing the physician assistant.  Further information has been requested.
Fever- 102.8   4pm on 1/2 until 10am on 1/3 When taking Tylenol temp down to 101.3 Heart rate high (110) when resting on 1/2 and into early morning hours of 1/3.  Note I take a beta blocker. Medication- Lisinopril, amlodipine, and metropolol tartrate  Cold chills Muscle aches Headache  started 1/2 constant until 1/5. Still have headache off and on and can feel it when I couch.  Tested for COVID  to rule out other possible issues on 1/4- Negative report on 1/5 Nausea- minor on 1/3 until 1/4  No redness at shot site Arm  hardly sore  No reaction on first round other very little soreness at shot site.
Pt went home and noticed that evening that they had full body joint pain and a migraine headache within 6 hours of the shot. The pt is still having full body joint pain 4 weeks after the shot.
I started having random hives all over my body with severe itching about a month after the vaccine. It made me highly uncomfortable to where I was unable to go outside. I never had hives before. These were very unusual and happened at random times, at night, in the morning, when outside, in the afternoon at home. There was no common theme to these. I had to shower multiple times a day to get some relief but was short-lived.
No additional adverse effects; patient was administered an improperly stored dose of either VAQTA, PEDVAX HIB, or GARDASIL9; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. This report concerns 1 patient and 2 combination products.  On 12-JAN-2020, the patient was vaccinated with an improperly stored dose of either hepatitis a vaccine, inactivated (VAQTA) lot # S010727, expiration date 26-JUL-2020, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S006471, expiration date 22-JAN-2022 or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621926, expiration date 28-NOV-2021 (doses and routes of administration were not reported) all for prophylaxis. There was no adverse event reported. The vaccines experienced temperature excursion of 34.9 degrees F (F) for 7 minutes and 48.2 F for 5 hours. There was no previous temperature excursion reported. The digital data logger was involved.
I woke up the next day and had a headache, stomach pain, and nausea and when I tried to get up I was really weak later in the day I felt like I had a fever and checked my temperature and had fever of 100.1. So I took some Tylenol and later in the day began to have chills off and on for the next 3 days. I started having chest pains on the 22nd and I called the Dr. and they advised for me to go to the ED to get checked out I started feeling better the next day while I was in the hospital.  I stayed in the hospital for 4 days. When I was in the ED they said I had heart stress and later on that day he stated I had Pericarditis and that I had high levels of Troponin and they were thinking it was from the booster shot. My pain is more on the right side of my chest than my left side.
Extreme fatigue, foggy, constant headache at the back of the head, vertigo, dizziness, clogged ears, ringing in the ears.  The symptoms have been going on for 6 months now. All the tests came back negative, but the symptoms continue
Information has been received from a certified medical assistant and a physician (patient's dermatologist) concerning a 14 year old female student who was vaccinated in April 2007 with her third dose of Gardasil in the left arm and developed an injection site reaction. There was no concomitant medication. In May 20007 the patient developed left arm swelling, redness, tenderness and warm and firm to touch. The patient noted this did not happen with the first and second injections. The patient had recovered three weeks post injection. The patient's OB/GYN office who administered the Gardasil was not concerned. The patient's mother was concerned and took her to a dermatologist. Cool compresses were recommended for the patient. Additional information has been requested.
giant hive & fever 102 p/2nd dose in post exposure series;sent to Er & treated w/Decadron;seen again by MD w/persistent giant hive;inj site is fine;tx w/atarax;child bitten by baby raccoon that was not captured;
Case number PHEH2014US021993 is an initial spontaneous report received from a consumer (patient's wife) on 29 Oct 2014 with a follow up information report received from a consumer (patient's wife) on 29 Oct 2014. This report refers to a 66 years old male patient. His vaccination history included influenza vaccine (manufacturer and batch number: not reported) at a dose of 0.5 ml intramuscularly. On 28 Oct 2014 evening, he had chills and it was unusual for the patient. The outcome of chills was not reported. The seriousness and causality of the events were not reported. Follow up information report received from a consumer (patient's wife) on 29 Oct 2014: Patient demographics (month and year of birth and age) and vaccination date updated.
Symptoms started the evening of 6/5/2012 as fever of 102 and pain in left jaw and pain plus swelling of the left arm shot site that made it impossible to sleep on that side. The fever lasted through 6/7/2012 and was treated with Tylenol. I also iced the sore shot site. The swelling is almost gone today 6/12/2012 with a slight amount of pain left. The only other symptom that is persisting is the sore jaw on the left side. I have never had a adverse reaction to a shot before.
5-10 min after receiving vaccine child fell off exam table (possible syncopal episode) hit head and had a seizure.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including received Paxlovid from 01Aug2022 to 05Aug2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, warm.  TX:  KEFLEX, BENADRYL, cool compress.
New onset of bi occipital headache, moderate to severe intensity, lasted 4 days and dulled to mild to moderate and continues to occur daily.  No history of previous chronic headache.
injeciotn site is warm; injection site is swollen; injection site is itchy; injection site is red; Chills; Sore Throat; Aching Bones; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), BONE PAIN (Aching Bones), VACCINATION SITE WARMTH (injeciotn site is warm), CHILLS (Chills) and VACCINATION SITE SWELLING (injection site is swollen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), BONE PAIN (Aching Bones) and CHILLS (Chills). On 15-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injeciotn site is warm), VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE PRURITUS (injection site is itchy) and VACCINATION SITE ERYTHEMA (injection site is red). On 15-Apr-2021, OROPHARYNGEAL PAIN (Sore Throat), BONE PAIN (Aching Bones) and CHILLS (Chills) had resolved. On 18-Apr-2021, VACCINATION SITE ERYTHEMA (injection site is red) had resolved. At the time of the report, VACCINATION SITE WARMTH (injeciotn site is warm), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PRURITUS (injection site is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were given by the reporter. No treatment medication were given by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-077797 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077797:CROSSLINKED WITH DOSE 1