chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left Lip numbness with increasing blisters inside lower lip, began about 50 mins post injection, lasted approximately 24 hours. Numbness bilateral feet from arches to toes, started approximately 4 hrs. post injection, lasted until next morning
Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib; This non-serious case was received during monitoring on 12-APR-2023 with the following Primary ID 2573153-1. The original narrative from the sender is the following:  Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Patient was given multi dose that contained Hib as well as single antigen ACTHib causing a double dose of Hib".  No further information is expected.
3/13/2023 Client reports reddened area and rash in R armpit with itching, rash was noted on lower legs with itching. Client used Benadryl lotion to rash areas and took Benadryl by mouth.
About an hour after I got it I felt an odd  shock all over my body, then a cold and hot flushing sensation all over.  I was jittery the rest of the day.   Five days later I had more of the cold shot flushes and realized they were adrenaline surges, accompanied by severe anxiety.  It has progressively worsened and I am having loose stools, a 10 lb weight loss, and have been increasingly unable to work (I am a Public Health RN).    I am having symptoms of POTS syndrome.  I wish I had never taken the vaccine.  This is absolutely horrible.  My heart pounds when I get up and move about.  My BP  and heart rate are fluctuating wildly.  I am nauseated.  Having flushing.  Went to the ER because my arms and legs were tingling so badly and the adrenaline surges.
On july 8th 2021 I had a case of extreme hives all over body and had to go to ER. I was given 50mg of Prendisone for 1 week every day. And proceeded to become diabetic. Extreme thirts, excessive urination, healing of cuts was slow. On Aug. 4th 2021 I was waiting for my doctor apt but everything was really bad to the point I was wetting my pants b3ecuase I could not make to bathroom. So I checked my blood sugar and it was 488. My doctors started me on metformin.
Sore throat progressing to paroxysmal coughing to blinding headache with photophobia, fever and body aches.
Seizures, vomiting , high blood pressure 178/99 . Required medication for nausea vomiting and blood pressure didn't go down had to be admitted. Patient declinded for 6 days and was unable to walk. Was discharged to long term care rehab.
Mother reports appearance of "bug bite" at injection site which increased in size and redness over 3 days. On 9-8-07. Mother took child to Urgent Care Clinic. Diagnosis of  abscess and mother states it was lanced and drained and packed. Follow-up with family physician was made 9-12-07 packing removed. Infection resolving per Mother.
This spontaneous report as received from a physician refers to an 80 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately April 2014 (reported as one and half years ago), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). In July 2015, the patient developed shingles. The outcome of shingles was reported as recovered on an unknown date in 2015. The relatedness between the adverse event of shingles and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Patient complaint of itchiness on the injection site on his right deltoid, per patient itchiness spread throughout the same arm. Vital signs taken, stable. Benadryl 25 mg was given orally at 11 am, per patient itchiness was subsiding. Per patient he was feeling chest heaviness, and he was feeling nervous. Respiration rate was 18, lungs were clear at the time. Patient was monitored for further 30 minutes after medication was given. Per patient he was feeling better and patient teaching regarding any further reaction to seek 911,  patient verbalized understanding.
Hives/risen, upright and red, and itchy/ patient used Benadryl and symptoms subsided the following day Blurred vision in right eye/went away on it's own the following morning
Headache, Myalgia, Diarrhea, NauseaVomiting, chills Narrative:
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: The patient developed a joint infection in her elbow requiring a visit to the ER for antibiotics and a follow up with her primary provider.
Swollen lymphnode and pain left armpit starting May 5 (4 days after injection)
had COVID-19 once after the second dose and then following the booster; had COVID-19 once after the second dose and then following the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID-19 once after the second dose and then following the booster".  Additional information: Respondent received the Comiranty vaccine and booster and then had COVID-19 once after the second dose and then following the booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored VAQTA (dosing regimen unspecified) (L023232 (also reported as 1023232), exp: 25-FEB-2017). No concomitant medications reported. No adverse effects reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse via company representative regarding male patients of unknown age. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL 9 (lot#, expiration date and dosing details were not reported), intramuscularly for prophylaxis. On an unknown date, one out of five male patients experienced syncope immediately after administration of GARDASIL 9. The patients visited physician to seek medical attention. The outcome of syncope was reported as fully recovered. Causality assessment was not provided by the reporter.
Redness/swelling at site of injection and surrounding areas, hot to touch. Swelling increased 8/1 to approximate baseball-sized spot.
12/23/2020: 2 hr after injection, patient noted swollen lymph nodes, nausea, room spinning (motion sickness-like) sx. Stayed home from work that day and slept. 12/24/2020: "typical injection site pain" 12/30/2020: injection site hot, itchy, welts 12/31/2020: area of welts doubled in size to entire upper left arm; throat starting to close up
c/o pain upon injection.  By the evening, pain from shoulder to elbow.  Unable to raise arm. No rednes or swelling at site.
The morning after the vaccination, pt noticed a 4x6 cm macular, indurated, painful, pruitic, erythematous lesion on Right upper arm, at site of DTaP vaccination. Pain improved by 05/20/2004 (Day 2) Pt. given prescription for Tylenol, Benadryl, and Hydrocortisone.
had severe pain after the shot; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent (mother).  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 19Mar2021, outcome "unknown", described as "had severe pain after the shot". Therapeutic measures were not taken as a result of pain. Additional information: the nurse informed them not to take any medicines and the reporter (mother) wanted to confirm if that information is true.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very vivid dreams after the first dose for the first 3-4 nights. Heart seems to flutter in chest now especially when laying on my right side. Have to lay on my back or left side to make it stop when it starts. Left armpit lymph node stays swollen a lot even months after the injection which never happened before. It goes away at times but tends to come back often. The lymph node looks to bulge from armpit when compared to the right side.
pt recvd vax 21AUG95 & had numbing to LVD during the day;next day arm felt if bruised, no signs of bruise evening of 22AUG95 had t101.4 to 102;23AUG95 left work d/t nausea, PM when awoke had large swollen area LUD;flu like sxs
Sunday 16th noticed lump and hives at the injection site around noon, c/o temporal headache off and on for the past 5 days at times becoming severe. Vomited 1x @ approx 8-9pm on Monday the 17th. Tuesday the 18th had diarrhea. Wednesday 19th left school early due to headache and above listed symptoms, taken to MD, neuro assessment completed = nothing abnormal detected. No fever, no muscle weakness, appetite is unchanged. NO C/O headache this AM 21st prior to leaving for school.
Severe itching and swelling at injection site, using hydrocortisone 1% plus and cold pack
Redness and increased temperature, and tenderness around whole upper arm same day after injection. Treated with Keflex, ice, Benadryl, and Vioxx.
pt recv vax & pt exp rash & vesicles;@ the time of report, the number of lesions was unk;
Information has been received from a physician assistant concerning a 16 year old female with negative medical history who on 13-APR-2009 received the first dose of GARDASIL IM in the arm (Lot #660618/0572X). There are no concomitant vaccines or medications. On 13-APR-2009 after receiving the first dose, the patient experienced syncope 5 minutes. Subsequently, the patient recovered by the time she left the physician's office. The physician assistant reported that it was unknown if the patient had eaten that morning, but the patient was nervous because her sister had told her the shot would really hurt. Additional information has been requested.
Bee sting sensations at random places on her body; Itching at random places on her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body).   At the time of the report, PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. The patient had no drug reactions/allergies. On an unknown date the patient was vaccinated with hepatitis B vaccine (manufacturer unknown and RECOMBIVAX HB could not be ruled out) (dose, route and lot # were unknown). The patient had negative titers. Her AB quantitative was 6.7 and hepatitis surface AB was negative. The outcome of event was unknown. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
blood in her bowel movements; bowel movement were like sticky mucus; really bad stomach cramps; her bones were aching; headache; chills; This is spontaneous report from a contactable consumer reported for self. This 59-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration right arm on 15May2021 13:20 at the age of 59-year-old (Lot number: EW0175) as 2nd dose, single for covid-19 immunisation. Medical history included Uterine cancer from 1991 (reported as had about 30 years ago, as of 18May2021), she did have the Covid 19 virus in Mar2020. Concomitant products included paracetamol (TYLENOL 8 HOUR) for headache. None other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Left arm Lot number:ER8731 on 24Apr2021 12:15 PM at the age of 59-year-old for covid-19 immunisation and experienced sore arm. The second dose she received on Saturday, 15May2021 and Sunday morning, 16May2021, she had a bad headache and her bones were aching. Her concerns started yesterday, Monday, 17May2021 when she started getting real bad stomach cramps. And her bowel movements were not like normal bowel movements. Her bowel movements were like a sticky mucus. This morning, 18May2021, there was dark blood in her bowel movement. There was blood in the toilet. But on Sunday 16May2021 when she was getting the chills and stomach cramps (17May2021) and then the blood in her bowel movement this morning, 18May2021, she was concerned. She's asking if this is normal. The chills have gone away but she's still concerned since the sticky bowel movements and blood in her bowel movements started after she received the Covid 19 vaccine. Afterwards, she had headache and chills, but said it already subsided. She said her main concern was that she had really bad stomach cramps, and her bowel movement were like sticky mucus on 17May2021. AEs did not require a visit emergency room and physician office. Outcome of the event real bad stomach cramps, bowel movements were like a sticky mucus, blood in her bowel movements, bones were aching was not recovered. Outcome of the events headache and chills was recovered in May2021.
swollen, redness, swollen by elbow now went down-it was hot but it's not like it was before;took OTC generic antihistamine;
8/27/15 pneumonia vaccine - arm sore & red (spot size of tennis ball) for approximately 10 days-1st 2 days could not raise arm above shoulder-applied ice after calling dr on 6th day-was Okay after approximately 12 days-had bad headache first 24 hrs and very sleepy.
Information has been received from a pharmacist concerning a 54 year old female patient who on approximately 24-MAY-2012 (reported as about 3 weeks ago) was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On approximately 24-MAY-2012 (reported as about 3 weeks ago) the patient had a lot of swelling and redness at the injection site. The patient did not seek medical attention. At the time of report, the patient was recovered. Follow up information was received from the registered pharmacist reporting that the 54 year old female patient with a previous history of shingles and no illness at the time of vaccination, on 22-MAY-2012 at 14:00 was vaccinated with the first 0.65 ml dose of ZOSTAVAX (subcutaneously on her upper back arm, it was the arm that had shingles (lot number 669862/0363AA, Exp. Date: 09-JUN-2012). The pharmacist stated that on 23-MAY-2012, the patient's arm had a lump with a fever and it itched. The experience lasted two weeks and in June 2012, it went away on its own (Also reported as not recovered. The relatedness for a lot of swelling at the injection site, patient had an arm with a lump that itched, patient had an arm with a fever and a lot of redness at the injection site was unknown for ZOSTAVAX. Additional information is not expected.
Large 2.5" x 3" raised, warm, reddened area under right arm.  Area is also somewhat bruised.   She stated that the same thing happened w/first varicella inj on 4/7/15, but we didn't see this. Instructed her to use ibuprofen and Benadryl and if not better was going to contact us.
Information has been received from a physician concerning a female with warts on her hands who was vaccinated with Gardasil.  Subsequently the patient's warts got worse while she was taking her final exams.  There was no illness reported at the time of vaccination.  The patient's warts got worse persisted.  Additional information is not expected.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Our staff pharmacist was trying to select the 7.5 mcg/0.5mL haemophilus B conjugate vaccine from our hospital's refrigerator stock. He noted that the Liquid PedvaxHIB does not list the strength (7.5 mcg) anywhere on the vial....just 0.5mL. Although Liquid PedvaxHIB is only available in a 7.5mcg/0.5mL concentration, the brand name on the manufacturers label is very small, and is 3 text lines below bolded, upper case "HAEMOPHILUS B CONJUGATE VACCINE".
She had the shot and got the disease a year after / Shot doesn't work!; She had the shot and got the disease a year after; Was in more pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in twenties).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, had more pain after the shot and got disease a year after. The reporter stated that, the shot did not work. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles and laboratory confirmation for shingles were not provided. This case was linked with case US2021AMR092424, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092424:Same reporter.
hot flashes; and some pain; extreme chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills). At the time of the report, HOT FLUSH (hot flashes), PAIN (and some pain) and CHILLS (extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment medications provided
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 120 hours with the highest recorded temperature of 53 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Headache, Myalgia, NauseaVomiting, fatigue Narratie: 1/13 @1700 befanfeeling "achy"; 1/14 @ noon began nausea & fatigue, low grade (99) temp took Aleve; 1/15 nausea, achy, headache; states beginning to feel better. Has taken home meds - Aleve and phnergan.