chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash breakout on both of calves; This is a spontaneous report from a non-contactable consumer. This patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number: EN6202) at single dose for COVID-19 immunisation. The patient also received hydrocortisone injection via unspecified route of administration at unspecified dosage every six months for a sport injury. The patient's medical history included sport injury. The patient's concomitant medications were not reported. The patient had vaccine shot on Friday (unspecified date). The patient was also getting every six months hydrocortisone shots for like a sport injury because the patient work in a university. The patient had a rash breakout on both of calves and like it is a floaty rash. It is not like all in one place it is like around upper part where ankle is, in the middle of calve where muscle is and around the side of the calve. The patient wanted to know did medication/vaccine get into blood stream and caused this rash in skin and what's the deal. The patient stated would go to doctor and orthopedic surgeon. The action taken of COVID-19 vaccine was not applicable. The action taken of hydrocortisone was unknown. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of Hydrocortisone sodium succinate in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Hydrocortisone sodium succinate has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.
Red, or pink rash, sometimes with little white bumps that would and still sporadically show up under armpits and under breast area.  Very uncomfortable and itchy to where it was hard to focus.  The more I scratch(ed), the worse it got(gets).  It's absolutely awful. Tried using OTC itch relief creams, gels, etc. which only soothed it for a short period of time.   Saw my family doctor 1x.  Saw my dermatologist 3x. I am still having similar outbreaks, just not nearly as large an area as before.
Got the shot later got the ShinglesSuspected Vaccination Failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and then about a month later got the shingles and would not wish this on the devil. The physician said the shingles was mild. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Received monovalent booster ( spikevax) in error instead of bivalent booster.
Starting the second day after the shot, I experienced deep anxienty and depression symptoms.  I suffer from this on a regular basis and have dealt with this since 1974, but this was the worst I have had in many years. It lasted for two days and then today it has cleared.  There is no other reason why I would have this except for the vaccine.  I am OK now and did not contact anyone about it.  I wanted to report this because I did not see it on the list of side effects and it would be nice for others to know it was coming.  Please feel free to contact me if necessary.  Thank you for getting me the vaccine and keep up the good work.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult female patient of unspecified age. This refers 81 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
on 1/15/21 woke with a rash all over my face and very itchy, took Benadryl and went on with my day around 9pm that night my face was swollen and left eye was swollen shut. Went to ER and was told a possible reaction to the Covid vaccine and was given a oral  steriod in the er that night and sent home with a script for a steriod for 3 days. Went home and woke up (1/16/21 that morning 3 times as I had to change my clothes as I was soaking wet in sweat. Changed my clothes and took my meds and as the night went on the swollen in my face got worse and took more Benadryl.  Sunday 1/17/21 swollen no better and the rash is worse. I took it easy and took meds.. Monday 1/18/2021 woke up with a very swollen face and very itchy. Face very warm to the touch (No fever 97.9) Called my primary Doctor and she told me to come over asap as the I was feeling any better and getting worse. Both eyes are almost swollen shout and my face is very hot to the touch. Doctor extended my dose of steriods and gave me a script for Pepcidfor 7 days.
Patient scheduled for 3 dose of Moderna vaccine which was given by nursing staff.  Patient did not present proof of first 2 doses.  After administration of Moderna vaccine, it was discovered that first 2 doses were Pfizer
Third dose/booster dose; some nerving sensations (tingling) all over my body.; flushing; Face got itchy, flushed, red; Face got itchy, flushed, red; Face got itchy, flushed, red; tongue got very, very dry; Felt little pricks of nerve endings all over her body, in different parts of her body; This is a spontaneous report received from contactable reporter.   The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200133585.  A 69 year-old female patient received bnt162b2 (BNT162B2, solution for injection), administration date 12Nov2021 (Lot number: FH8028) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6201), administration date: 15Feb2021, when the patient was 69 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, provided as either EV6207, EU6207 or EN6207-this is handwritten on the vaccine record card.), administration date: 19Mar2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Third dose/booster dose"; PARAESTHESIA (non-serious), outcome "unknown", described as "some nerving sensations (tingling) all over my body."; FLUSHING (non-serious), outcome "unknown", described as "flushing"; PRURITUS (non-serious) with onset 12Nov2021, outcome "unknown", FLUSHING (non-serious), ERYTHEMA (non-serious) all with onset 12Nov2021, outcome "recovering" and all described as "Face got itchy, flushed, red"; TONGUE DRY (non-serious) with onset 12Nov2021, outcome "unknown", described as "tongue got very, very dry"; NEURALGIA (non-serious) with onset 12Nov2021, outcome "not recovered", described as "Felt little pricks of nerve endings all over her body, in different parts of her body". Therapeutic measures were taken as a result of paraesthesia, flushing, pruritus, flushing.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. Patient's concurrent conditions and relevant medical history was unknown. The pharmacist reported that, on 02-SEP-2014, the patient was inadvertently vaccinated with expired dose of PNEUMOVAX23 (lot number: J004080 with expiration date of 22-AUG-2014)(dose and route unspecified). Concomitant medications were unknown. No adverse effect was reported. The outcome of the events was unknown. The causality of the event with PNEUMOVAX23 was assessed as not related. Additional information has been requested.
Patient started feeling  faint and became very pale. Her back was extremely sweaty and she was not very coherent. Her husband was with her and helped us lower her to the ground. We utilized a cold compress and elevated her feet. She came to and began feeling much better after approximately 5 - 10 minutes post vaccination. We held her to watch her an additional 15 minutes afterwards.  Patient was able to walk to her car and did not feel she needed additional assistance.
1400 - HPV (GARDASIL administered), 1415 Pt reported shaking and sweating, tremors noted, skin pale, sweating noted.  EMS called by RN.  Pt. remains alert and oriented.  1440 Pt transported to Medical Center via ambulance.
Exactly one week from the day shot was administered, injection site enlarged, was red and swallon and started to itch.
Tingling/ Slight tingling on skin all over; slight numbness on face; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 16:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to aspirin (MANUFCATURER UNKNOWN). Concomitant medication included omega-3 (MANUFCATURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 01Apr2021 at 16:45, the patient experienced tingling and slight numbness on face. The patient had slight tingling on skin all over. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of slight tingling on skin all over and numbness in face was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
1st night chills real painful for 3 days in arm. Lingering pain for 11 days in left arm. Most intense pain in morning.
No additional adverse event; Caller is a Merck agent calling to report an adverse event on behalf of a vaccine coordinator for PROQUAD. The vaccine coordinator is not on the line. Caller reports that she received an email from the customer notifying her that a dose of PROQUAD was; This spontaneous report was received from an other health care professional via company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On an unspecified day, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) administered intramuscularly (Incorrect route of product administration) administered as prophylaxis and reconstituted with sterile diluent (dosage information, lot number, and expiration date were not provided). No additional adverse events (AE) were reported.  Follow up information has been received from the clinical supervisor at the pediatric office on 21-JUN-2022. Patient's identifiers were provided, therefore, this case is now considered valid.  The patient was a 4-year-old female, who on 26-MAY-2022, presented to the office with her grandmother, for her 4 years old child check up. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot number U026794, expiration date 26-FEB-2023, was ordered as appropriate for age. The Certified Medical Assistant who prepared the vaccine administered it intramuscularly(in the left vastus lateralis) instead of subcutaneously as recommended in the packaging insert. The patient was not harmed. No adverse reactions were noticed. No post vaccine concerns were presented. The CMA was supervised by a registered nurse, who addressed the error inmediately and education was provided, the incident was discussed and the parents were advised.   The reporter considered the event was not related to measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Chills, Headache, extreme fatigue, slight nausea which lasted for 70 hours.
patient received expired dose of Daptacel; Initial information received on 10-Apr-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 6 months old female patient who received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) via unknown route in unknown administration site on 09-Apr-2020 for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. 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.
On December 30th, I was coughing and my nose was running. I also was really tired. I felt like I had a bad cold which got better but I was still very tired. I was having these symptoms for about a week. I wasn't feeling that bad I just did not have enough energy to go back to work. I took some Ibuprofen for my headache which helped me to sleep but when I woke up, I could still feel the symptoms.
About 10 days after first vaccine, I became very itchy all over my body and then noticed a blotchy rash under my skin which became more obvious over the following days. It hasn't gone completely away but has faded and gotten less itchy. I got my second Moderna vaccine yesterday and hope it doesn't get worse but my doctor said I can take Benedryl if it gets worse. I have heard of people getting itchy and a rash on the arm but haven't heard much about this type of rash and thought I should report it.
Fatigue; Nausea; Dizziness; Black stool; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 25Feb2021, the patient experienced fatigue, nausea and dizziness serious enough to stay home from work and oily bright black stool (this was only once). The patient assumed that was from vaccine, symptoms started evening of vaccination (11:20 am), were worse the next day and gone within 48hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, nausea, dizziness and oily bright black stool was recovered within 48 hours on 27Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Insomnia followed by fever ,chills,  muscle pains, extreme pain at injection site,  vomitting,  skin hurt all over,  dizziness, and I had a headache.    Everytime I moved my eyes, I could hear a whooshing sound in my ears.  I had to wear sunglasses and stay in the dark, as the light hurt my eyes.  It lasted for 24 hours, and another 12 hours of  and extreme stomach ache.
Patient complained of swollen arm and arm pain of left arm around injection site.. rash later appeared next day..no fever.. warm to the touch.
With in seconds of receiving vaccine had seizure like effect in head resulting in out of body like experience, muffled hearing, a foul taste in my mouth and altered state of eurphoria. Could not report symptoms but if had been asked directly could have. REalised half way driving home that I should not be driving. Eurphoria lasted for 24 hours. Was on phone constantly the next day for 7 hours straight without eating.  Could not remember what some items were like a drone. Had to ask = that thing that flies with a camera. Short term memory loss that continues. Facial numbness began 48 hours after injection. Facial numbness continues changing in areas of right side of my face. Felt extremely vulnerable. Wore my same clothing for 4 days as I did not remember that I had clean clothing. Did not remember that I should notify medical personal until late 2/20.
Itchiness on right side of body, Mild headache, running nose and moderate soreness around injection site.
Information has been received from a physician, via a company representative, concerning a 55 year old female patient with asthma, who on 12-NOV-1998 was vaccinated with a dose of PNEUMOVAX (manufacturer unspecified).  Concomitant therapy included albuterol and possibly other asthma medications.  On approximately 17-NOV-1998 ("about 5 days after injection"), the patient experienced asthmatic bronchitis.  She was seen and treated by the physician on 17, 20 and 21-NOV-1998.  At the time of this report, the outcome of the event was unknown.  Additional information has been requested.
Pt received the 2nd Moderna vaccine in the series in outside location. we do not have the Lot number for this vaccine as it was not given by our facility.  He began having chest pain that day after receiving the vaccine and came to the hospital on day 3 of chestpain. No prior similar events, no cardiovascular risk factors. Pt is better with sitting up and leaning forward. pt was admitted to the hsoptal and started on Ibuprofen and Colchicine  Pt was discharged after 3 days with significant improvement in his status. On discharge pain was 0 out of 10. To continue Ibuprofen x 1 week and colchicine for 6 weeks. Cardiology cleared pt for discharge
had the 1st / shot over 11 months ago / need to start over since it's been longer than 6 months?; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date 11 months 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: This case was reported by patient herself/himself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient not yet receive second dose of Shingrix vaccine, which led to incomplete course of vaccination. The patient asked need to start over since it has been longer than 6 months
Headache, Myalgia, chills and arm pain was reported as heaviness Narrative:
6days p/vax pt exp vomiting, bloody stools, crying;Dx w/intussusception; ultrasound confirmed;Annual follow-up dated 10/12/00 provided no additional data.
Patient received Spikevax in the left arm and flucelvax in the right arm. Right after the flu vaccine was administered, the patient quickly stood up and gestured that he could not breathe. Pharmacist grabbed and Epipen and delegated staff to call 911, just as she was about to administer the Epipen the patient coughed and seemed to be breathing sufficiently.
supraventricular tachycardia lasting approximately 40 minutes with heart rate ranging from 230-250 b/m
After injection was given, a painful, inflamed, swollen, red bump appeared at the injection site.  The patient reported that the spot was so painful that it hurt to put clothes on or sleep  on. After it healed, it left a brown spot, like a scar.
injection site soreness and pain; fever of 104; muscle aches; This is a spontaneous report from a contactable consumer (patients wife).  A 70-years-old male patient received bnt162b2 (BNT162B2) , via  an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported.  The reporter reports her husband received the second dose on 26Jan2021. Her husband didn't experience any symptoms except injection site soreness and pain. On Saturday, (30jan2021) her husband began to have a fever of 104 and muscle aches. She gave her husband Tylenol for his fever and it helped. Her husband went to have a rapid COVID test and it came back negative. She  would like to know if it is possible for her husband to be having a delayed reaction to the vaccine. The outcome of the event of fever was recovered , the remaining events was not reported.   Information on the lot/batch number has been requested.
Profuse sweating starting on 12/22/2013 in the early morning and continuing periodically through today, 2/20/2014. Worse sweating is in the bed at night. Also no energy. My immune system is down and came down with pneumonia on 1/15/2014 also pink eye in both eyes. Treated with antibiotics for 10 days the pneumonia and pink eye disappeared but the sweats and severe lack of energy still continues through today 2/20/2014. Have had a battery of blood tests and all came out normal. Dr. now scheduling chest CT. Did have chest xrays that showed I contracted the pneumonia on 1/18/2014.
I got hives from the vaccine back in May of this year.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I got hives from the vaccine back in May of this year.) 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. In May 2021, the patient experienced URTICARIA (I got hives from the vaccine back in May of this year.). At the time of the report, URTICARIA (I got hives from the vaccine back in May of this year.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.   The treatment history was not provided.