chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 Days after second dose patient developed a large red rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet; Raised rash on both arms from elbow to wrist,; 5 Days after second dose patient developed a large red rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet; Itchy rash; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 06Apr2021 at 15:30 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, since unknown date. The patient had no known allergies. Concomitant medications included SINGULAIR on an unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 16Mar2021 at 16:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:00, five days after second dose, the patient developed a large red, raised rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet. It was itchy and warm. It started fading after 24 hours. Therapeutic measures were taken as a result of these events and included treatment with cortisone 10 and benadryl. 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 large red, raised rash on both arms from elbow to wrist, slightly on both knees and thighs and also on both ankles and top of feet. It was itchy and warm were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Blisters in patient's hand and toes; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters in patient's hand and toes) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included MS in 1991 and Autoimmune disorder. Concomitant products included AMLODIPINE for Hypertension, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 15-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced BLISTER (Blisters in patient's hand and toes). The patient was treated with CLOBETASOL PROPIONATE ongoing from 03-Mar-2021 for Adverse event, at a dose of dosage form. At the time of the report, BLISTER (Blisters in patient's hand and toes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient treatment data was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant FU appended, Medical information, patient details, concomitant medication and treatment medication were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
hallucinating; seeing spots; dreaming is unbelivable; pain; buzzing on her neck; body has no strength; could not stand straight; nausea; vomiting; A spontaneous report  was received from a female consumer regarding herself who received first dose of Moderna Covid-19 vaccine (mRNA-1273)and have experienced hallucinations, excessive dreaming, loss of strength, inability to stand up, feeling abnormal, pain, nausea and vomiting.  The patient's medical history was not provided. Her concomitant medications were not provided. No information on allergies.   On 14-FEB-2021, prior to the onset of events, the patient received her first of two planned doses of Covid-19 vaccine (mRNA-1273) for the prophylaxis of Covid-19 infection at noon time.   On 15-FEB-2021, she said, she still feeling it in her brain, her head and her body. She has no energy, could not even get up, she has buzzing on her neck and her body has no strength. She is hallucinating, seeing spots, seeing all kinds of things and her dreaming is unbelievable. She had so much pain, nausea and vomiting. She hung up the phone saying no time for this. It is not known whether the patient has any psychiatric history in the past. Treatment information was not provided.  Action taken with the 2nd dose of mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown at the time of report. Follow up information is expected.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a pharmacy student referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 31-AUG-2016, the patient was administered with a dose of PROQUAD intramuscularly instead of subcutaneously (product use issue). No adverse effects were reported. Additional information has been requested.
In the overnight hours between 12/29 and 12/30 the injection site became sore red and swollen again as if it was a fresh shot. It has heat to it and is slightly larger and harder then the initial swelling that had completely disappeared after 3 or 4 days of 1st dose. It was not sore unless touched, however late yesterday on 12/30 it did get sore without touch.
light headed and dizziness; Body ache; chills; rash on the arm/rashes was still in her arm and was nowspreading all the way to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed and dizziness), VACCINATION SITE RASH (rash on the arm/rashes was still in her arm and was nowspreading all the way to the elbow), MYALGIA (Body ache) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol,Codeine) and Allergic to cats. Concomitant products included LORATADINE from 2000 to an unknown date for Allergic to cats.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the arm/rashes was still in her arm and was nowspreading all the way to the elbow). On 20-Jan-2021, the patient experienced MYALGIA (Body ache) and CHILLS (chills). On 17-Feb-2021, the patient experienced DIZZINESS (light headed and dizziness). On 03-Feb-2021, VACCINATION SITE RASH (rash on the arm/rashes was still in her arm and was nowspreading all the way to the elbow) had resolved. On 24-Feb-2021, DIZZINESS (light headed and dizziness) had resolved. At the time of the report, MYALGIA (Body ache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-022053 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No specific follow-up information recorded.
AFTER GETTING THE COVID 19 VACCINE, PATIENT WAS FEELING FINE AND WAS ADAMANT ABOUT LEAVING THE STORE AGAINST RPH ADVISED TO STAY BACK FOR 15 MINS FOR MONITORING. PER PATIENT, HE HAD TO USE THE RESTRROM URGENTLY. AFTER LEAVING THE STORE, PATIENT WAS FEELING FINE, BUT ABOUT 15 MINS LATER- IN THE PARKING LOT, PATIENT'S GIRLFRIEND CAME BACK INTO THE STORE STATING THAT PATIENT IS SLEEPING AND NOT ANSWERING HER, RPH RUSHED OUT TO HELP, AT THIS TIME - PATIENT IS FEELING BETTER AND MORE RESPONSIVE. AFTER RPH CAME BACK TO THE STORE, BOTH PATIENT AND HIS GF LEFT BECAUSE THEY FEEL BETTER .  2 HOURS LATER, WE CALLED TO FOLLOW UP WITH PATIENT AND PER PATIENT - HE IS FEELING BETTER, NO PAIN, NO RASH NO SYMPTOMS. COMPLETELY BETTER.
Patient developed an itchy rash at injection site the day after injection. Red skin warm to touch that spread down her arm, to her elbow. Patient was treated with Prednisone 20 mg - take one table by mouth 2 times daily for 5 days. Rx prescribed and started on 02/27/19. Patient advised to use ice at swelling site in arm and to follow up if symptoms get worse or do not improve in 5 days.
Swelling and redness over the pubic bone. Seen that night in the Urgent Care Clinic. The swelling decreased and was gone by the next day.
I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had another onset of diarrhea. that evening I had chills so bad that I could not get warm. Left arm is sore and swollen but mobile.
Prolonged diarrhea for several weeks after 1st Rota. Vomited after 2nd Rota. Vomited most of 3rd dose and diarrhea for 1 week after
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
pt called pharmacy stating that he noticed redness approximately 3 inches below shot area, no swelling burning or pain, wouldnt have noticed really except when he went to remove bandaid
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/17/2023.
NauseaVomiting, C/o of light headiness, swollen & itchy hands post vaccine. Initial BP was 154/88 , pulse of 76, Symptoms progress and complaint of Nausea and vomiting, Famotidine 20MG PO ordered, symptoms improved BP 125/82 pulse 81, D/C home at 1 PM no symptoms Narrative: /p of light headiness, swollen & itchy hands post vaccine. Initial BP was 154/88 , pulse of 76, Symptoms progress and complaint of Nausea and vomiting, Famotidine 20MG PO ordered, symptoms improved BP 125/82 pulse 81, D/C home at 1 PM no symptoms
I woke up in the morning with a headache and achiness. I took some aspirin and slept most of the day. The worst of it lasted until approximately 4 p.m.
Large red, hot, swollen area about 3 inches by 3 inches. 102 Fever for one day. Mild fatigue for one day.
We had an error where a vaccine was administered 3 weeks past; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had an error where a vaccine was administered 3 weeks past) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported. No concomitant medications was provided by the reporter.
Had a persisting outbreak of hives starting on 11/1. Had to go to urgent care to get steroid shot and antihistamines. Still continuing to this day 12/7 just not as bad.
This spontaneous report was received from an office manager concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 12-OCT-2016 and on 14-JAN-2017, the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). At the reporting time, the patient liked to receive a dose of GARDASIL 9. No adverse symptoms were reported.
I started getting a ringing noise in my ears and I still have it. It comes and goes. It gets louder at times. This symptom has been going on since my second dose. I went to my primary care doctor about this. He checked my ear and said that they looked fine.
a little bit of chill; like a slight bit of dizziness; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Batch/lot number: EH9899), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a little bit of chill and like a slight bit of dizziness on Dec2020 with outcome of unknown.
Same day & next day: On the drive home from the vaccination appointment, I noticed my upper lip was numb/tingling and a little swollen. It continued. I felt nauseous and tired the following day--sleeping all day. Exactly 7 days later (around 7:30-8 pm), my left arm at the injection site began itching. I woke up this morning and it is red, itchy and warm. I feel nauseous and dizzy, and periodically breakout in a cold sweat.
I had Rapid heart rate, and its all sinus rhythm. I was treated with beta blockers and metoprolol which didn't work. I kept having pulse rates over 100bpm. The cardiologist put a monitor on my heart,  I had constant rapid heart for a week so he changed my beta blocker to nancadolol, which partially controlled my rapid pulse. I still have high heart rate but less than before.
This is a spontaneous report from a contactable consumer. An 86-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2015, at single dose. The patient had never had this vaccine before. Relevant medical history included arthritis. Concomitant medications included vitamin D, TYLENOL for arthritis and meloxicam (unspecified trade name) since 3 years. Previously the patient received flu vaccine, every year. The patient mentioned that she had a very bad adverse reaction to PREVNAR 13 that lasted for two and a half month. On an unspecified date she had a skin biopsy done which showed that it was hypersensitivity vasculitis condition due to drugs and the vaccination that she had got, it took about 2 weeks for it and she was "bubbled out" constantly. Therapeutic measures were taken as a result of this event and included treatment with Prednisone in the middle of Aug. Outcome of this event was recovered. The patient was also highly allergic to certain things and this went on for two and a half month and it started out with hives and rash and it would 50 to 60% of her body was covered. She had to go to emergency room two different times.
Erythema minimal swelling noted over inner upper arm extending down over elbow. ?? No signs of induration, not increased warmth, no increased lymph nodes.
MEMBER RECEIVED ANTHRAX VACCINE 2AUG08 STARTED EXPERIENCING SYMPTOMS WITHIN APPOX. 5 HRS. AFTER ADMINISTRATION. SYMPTOMS INCLUDED: NAUSEA AND FATIGUE.  4AUG08 MEMBER STATES SHE BEGAN EXPERIENCING HEADACHE RATED 5 ON PAINSCALE 0-10. 5AUG08 MEMBER REPORTS EXPERIENCING SEVERE HEADACHE RATED 9 ON PAINSCALE 0-10, FOLLOWED BY PROJECTILE VOMITING.  HEADACHE AND VOMITING BEGAN AT APPROX. 0530 AND CONTINUED UNTIL 0900.  TO EASE THE PAIN MEMBER LAID DOWN AT 0915 AND AWOKE AT APPROX 1500 EXPERIENCING FATIGUE BUT NO HEADACHE OR VOMITING.
Information has been received from a Registered Nurse concerning a 5 months and 9 days old patient who on 15-FEB-2011 was vaccinated with the first dose of ROTATEQ (lot# not reported). No adverse effect reported. Additional information has been requested.
Patient had Janssen covid vaccine; she required one dose of either pfizer or Moderna. Patient should have received bivalent not Moderna dose 1.
On the next day, pt had redness, swelling at injection site and warmth - relieved with hydrocortisone cream and diphenhydramine.
Narrative:  Patient developed a rash approximately 5 hours post COVID vaccine administration. Rash was bilaterally on arms and trunk. Patient took 25mg bendadryl prior to going on local emergency room where he was observed and later sent home in stable condition and rash has since resolved.
Right arm 2 vaccines administered. Right upper arm with area of light erythema. No increased warmth but slightly indurated.
Information has been received from an RN concerning a 4 year old white male with no known drug allergies who on 3/1/01 was vaccinated IM with Hep-A virus vaccine inactivated in his left thigh. There was no concomitant medication. On 3/5/01, the pt began vomiting. On 3/8/01, the pt ran a fever of 103F for 24 hours, with the highest fever reaching 104F. The pt had no fluid or food intake during this time period. On 3/8/01, the pt went to the ER and was given IV fluids only and sent home. The pt's symptoms resolved in 2 days and he recovered on 3/10/01. Upon internal review, the pt's fever of 103F was determined to be an "Other Medical Event". No further details were provided.
Client vaccinated in beginning and end of April x 2 with Moderna vaccines.  Symptoms started 11/20/2021 - nasal congestion, sneezing, headache, myalgia.  Reported as case of breakthrough Covid in previously vaccinated person.
he passed 2 months later; Shingles Vax gave my husband Shingles; compromised immune system; Shingles Vax gave my husband Shingles; wiped out his platelets; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: he passed 2 months later) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Shingles Vax gave my husband Shingles) (serious criteria GSK medically significant), immunocompromised (Verbatim: compromised immune system) (serious criteria GSK medically significant), shingles (Verbatim: Shingles Vax gave my husband Shingles) and platelets decreased (Verbatim: wiped out his platelets). The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). The outcome of the vaccination failure was unknown and the outcome of the immunocompromised, shingles and platelets decreased were not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, immunocompromised, shingles and platelets decreased to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death, vaccination failure, immunocompromised, shingles and platelets decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023. This case was reported by a patient via interactive digital media. The reporter stated that shingles vaccination gave her husband Shingles, wiped out his platelets. The patient required 4 blood transfusions and with his compromised immune system he passed 2 months later. The case was considered as suspected vacciantion failure since the details regarding completion of primary vaccination failure, time to onset for shingles laboratory confirmation of shingles was not reported.  The follow-up could not be possible as no contact details were available; Reported Cause(s) of Death: Unknown cause of death
Fever 102.5, for 1 day...then 99.8 for 1 day...very achy joints and tired. I took Ibuprofen.  Was better after a couple of days
5/22/08 (L) upper arm red, swollen 2 days after shots. Treatment: Keflex, Benadryl, Ibuprofen.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's historical vaccine included PREVNAR 13 administered approximately in October 2015 (reported as 1 year ago). On 18-OCT-2016, the patient was vaccinated in an unspecified clinic with a dose of PNEUMOVAX 23 (dose, frequency, route and site of administration, lot #, expiration date not reported). On the same day, the patient was confused and did not remember that she had received PNEUMOVAX 23 earlier that day and was vaccinated with a dose of PREVNAR 13 in a pharmacy. The outcome of the events was unknown. The reporter did not assess the causal relationship between PNEUMOVAX 23 and the events. Additional information has been requested.
Patient presented to pharmacy on 8/28/18, stated that her injection site was swollen and painful for 5 days, it was a "knot". She said she had red streaks several inches wide and 3 inches long that started on second day through the 5th day. She said it had resolved when I asked her to show me her arm, with today being the fifth day. It therefore couldn't have lasted 5 days. This was her second SHINGRIX vaccine to complete the series, the first being given by me on 3/22/18 at 11 am and she never reacted. Also, her husband got his first SHINGRIX vaccine by me on 8/23/18 right after her and he did not have an adverse reaction.