chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient arrived to vaccination clinic for second dose of Pfizer vaccine.   Patient signed consent form stating that he knew they were receiving the manufacturer Pfizer. Prior to administration, patient was counseled that they would be receiving the Pfizer vaccine and confirmed with patient first dose received was Pfizer.  Consent form reviewed by vaccinator - Patient filled out vaccine consent form and checked "no" for the question "Have you received a previous COVID-19 vaccine made by a different manufacturer".  Shot was administered to patient's right deltoid. After administration, patient presented CDC card and vaccinator saw documented on patient's card that first dose given was "Moderna".  Vaccinator notified pharmacist and Director of Nursing services on site immediately after seeing patient's CDC card. Patient was counseled on recommendations from CDC to not receive a third dose of either Pfizer or Moderna. Patient was monitored for 30 minutes for signs and symptoms of reaction prior to leaving clinic.  Director of nursing services made a follow up phone call with patient approximately 45 minutes after patient left clinic.
Suddenly onset exhausted and disoriented. 13 hour nap. Frequent wakings with arm pain and panic.
extremely heavy clots that were dropping out of me in very huge chunks; excessive bleeding; I bled heavily for about an hour it was traumatic; This is a spontaneous report from a contactable other hcp (Patient). A 43-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ewo179) via an unspecified route of administration (age at vaccination 43-year) Right Arm on 29Apr2021 at 02:00 PM as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies were reported. Historical vaccine included first dose of BNT162B2 (lot number: ewo158) on 08Apr2021 for COVID-19 immunization; No reaction on exposure to previous Vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as No. On 10May2021 the patient experienced event reported as "extremely heavy clots that were dropping out of me in very huge chunks, excessive bleeding, she bled heavily for about an hour it was traumatic". The patient reported that "After taking my second dose on my next monthly period cycle I experienced excessive bleeding and extremely heavy clots that were dropping out of me in very huge chunks! I thought I was going to call 911. I bled heavily for about an hour it was traumatic. At this moment I'm doubting if I will take a booster shot because i'm a single Mom living in a shelter with my three kids and my children need me to be alive for them! I was scared that I wouldn't make it through! I thank  that he saved my life!". No treatment was received for the adverse events. The clinical outcome of the events was recovering.  Follow up information has been requested.
Pt recvd 3 doses of Engerix-B & titer report dated 13JAN92 indicated pt did not respond to protective levels;
This case was reported by a nurse and described the occurrence of rash in a 15 year old male patient who received Engerix B. The patient had no pre existing medical conditions. On 12 June 2006, the patient received the first dose of Engerix B. One week after vaccination with Engerix B, on an unspecified date in June 2006, the patient experienced a rash on the left deltoid region that was approximately the size of an apricot. The reporter considered that the event was possibly related to the use of Engerix B. The outcome was unknown at the time of reporting.
I noticed my arm was feeling sore again at the injection site the night before. When I woke up on February 13, 2021, I noticed a red raised bump at the site of injection. Within an hour the redness spread and was getting warmer and sore. Within a couple hours the bump was gone but the redness spread to a couple of inches in a blotchy pattern. It did not itch  at all and was sore only when I moved my arm or pressed on it. The bump has not returned yet and the redness and warmth are still there. The redness has also not spread anymore so far.  This is approximately 8 hours after I noticed the red bump. Otherwise I feel normal. I did not seek medical attention because at the time, I do not feel it is concerning, but I just wanted to report it for data purposes.
Pain in right arm. Swollen when using arm more often. Red rash below the injection site.
Left upper arm hot and red esp in area of Varicella vaccine, also had Pediarix but not as red in deltoid as SQ (triceps) area.  Extends from elbow to upper arm 5 inches x 3 inches wide.
rash on left leg between knee and ankle, rash itched; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration (left arm) on 16Jan2021 (14:45) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization. The patient's medical history included Myasthenia Gravis, MOHS surgery 2 times, Type 2 Diabetes, both knees and back surgeries, high blood pressure, and Penicillin allergy. Concomitant medications included unspecified medications for high blood pressure and diabetes Type 2 maintenance. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received the shot in left arm on 16Jan2021. The next day (17Jan2021, 14:00) he noticed rash on left leg between knee and ankle. He added that the rash itched. There was no treatment received for the adverse event. The outcome of event was recovering. The patient has not been tested for COVID-19 since the vaccination.
After 3 days developed bulge under injection arm pit 4" in diameter and 1.5" in depth, feels 75% solid, after 2 week became 33% smaller and getting more "jelly like". After 30 days from date of injection is still same.
The patient received their 1st booster 12/15/2021.  This means they were eligible to receive their 2nd booster on or after 4/15/2022 (4 months after their 1st booster).  The 2nd booster was administered/given to them 4/3/2022.  This is 12 days early. They were given their 2nd booster 12 days early.
Severe abdominal pain and diarrhea 11pm-3am 4/15-4/16
Symptoms:  Onset approximately 6 hours after injection of fever of 102 , severe body aches with joint pain, chills, loss of appetite, decline in cognitive abilities - brain fog.   These symptoms lasted for 72 hours.   Treatment:  I used Tylenol every 4 hours to try and alleviate the symptoms.  With treatment, the only improvement was a slight decrease in fever, but fever continued to be over 100.  The adverse events caused me to lose 2 days of work.
I developed pain, swelling and hives on the arm in which the vaccine was given. Once the hives were noticed I began taking Benadryl tablets and after 50mg the hives resolved overnight an additional 50mg of Benadryl was taken the following day. The redness and pain continued for several days.
Constipation, head soreness, weakness, nausea, and pelvic area burning.
administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAB (Twinrix) (batch number 3C422, expiry date 27th April 2021) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On 30 April 2021, the patient received Twinrix, which was expired on 27th April 202. No further events were reporter.
10 mins after vaccine admin. pt c/o dizzy --> sat down c/o ears ringing, blurred vision & seeing spots, nauseous & diaphoretic --> lasted approx 10 mins. BP 96/60.
The night of receiving the vaccine at around 12:30 am, patient started experiencing a fever at approx. 101 degrees F and nausea. Her left arm progressively increased in swelling.
The lymph nodes of her arm and neck became really swollen and hard to the touch which she; A spontaneous report was received from a Consumer concerning a 22 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lymphadenopathy.  The patient's medical history was not provided. Vitamins were reported as the concomitant medications.  On 12-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027l20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16-JAN-2021, after 4/5 days receiving the first dose of vaccine, the lymph nodes of her arm and neck became really swollen and hard to the touch which she described as very painful. The symptoms lasted for a week and thus the patient visited  a healthcare professional who advised her to take Tylenol. But the patient did not take the medicine.  Action taken with mRNA-1273 in response to the events was not reported.   On 23-JAN-2021, the outcome of the event was resolved.
I developed hives between the first and second day. Due to a high fever from the vaccine that was over 102, I am not sure at what point the hives started. The fever abated by Sunday. The hives were mostly on my face and upper body.  I waited to call the doctors until Monday and was told that I was the fourth person to call that day, with hives, that had received the Johnson and Johnson vaccine the previous Saturday.  I was told to take Benadryl and wait it out.   I continued to breakout in hives for a month following the injection.  After the first month I had random individual hives for a period of time.
sick; fever; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (in eye ) and shingles (in hair). Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick), fever (Verbatim: fever) and tiredness (Verbatim: tired). The outcome of the sickness and fever were not reported and the outcome of the tiredness was recovered/resolved (duration 1 week).   It was unknown if the reporter considered the sickness, fever and tiredness to be related to Shingles vaccine.   It was unknown if the company considered the sickness, fever and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot but got shingles anyway in his/her eye and hair.  The reporter stated that it was pretty awful.  The reporter further stated that the new vaccine was more effective they said and needed two doses.  The patient got his/her first dose of shingles vaccine last week and was sick with fever and so tired for a week. The reporter further stated that not sure if he/she would get the second one shingles vaccine.  The follow up would not possible as no contact details were available.
Sudden rash and increased anxiety. Liquid benadryl given.  1037 fine rash noted. Itching abated. 1047 rash abated.
No other AE and no PQC; HBP calling to report an inadvertent administration of PROQUAD and VARIVAX to a patient on the same day.  HBP reporting a patient received both vaccines on 10/31/2023.  This was the first dose of both vaccines for this patient.; This spontaneous report has been received from a nurse, regarding a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-OCT-2023, the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: W038809, which was determined to be valid, with an expiration date on 04-JUN-2024) and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W031813, which was determined to be valid, with an expiration date on 05-OCT-2024), both as prophylaxis (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not reported) (Accidental overdose).  No additional adverse event was provided.
Right arm felt funny for 2 days then right ear started feeling funny, later that night my ear swelled and became very painful and my right side of my neck and right side of jaw hurt. Went to the drs today and they said my ear drum is enlarged and looks like an infection is starting and can?t exclude the vaccine as a cause of all of the random swelling and pain because I?m at day 4 since onset of ear issues and day 6 since vaccine.
Chief complaint: Cough, tested positive for COVID-19 on Saturday, drop in oxygen saturation down to the 70s  This is a 70-year-old female who presented with the above-stated complaints.  In the emergency room she was found to require 3 L of oxygen to maintain saturations above 90%.  She does not wear oxygen at home.  She describes a mild productive cough.  Not much in the way of shortness of breath.  Denies fevers or chills.  Her symptoms have been ongoing for 3 days.  She is a poor historian.  It appears that she has a prior history of COVID-19 infection.  She denies any nausea, vomiting, diarrhea.  No real decrease in oral intake.  No abdominal pain.  Denies chest pain or palpitations.
She got the vaccine on the left arm, it was okay, and acted like the 1st vaccine, and about 7-8 days later she noticed a lump on her neck near her collar bone.  It feels like a round ball, not real big around the size of a dine, it is still there on 4/16/21, but not as big as it was.  She did not have any other symptoms.  On Monday she had a knot on her right leg which is still present.   She does notice that her left wrist swells up which has been present since the knot appeared on her neck.   She did call her doctor and she went to see him and he ordered X-rays and was sent to a throat doctor who said he did not see anything wrong, but no other treatment.  She has not run any fever, and has not taken anything for the symptoms.
3/26/21 HPI: 72 y.o. male who presents with SLURRED SPEECH, WEAKNESS AND CONFUSION.  PT SENT OVER FROM DOCTOR'S OFFICE WHERE WAS NOTED TO HAVE ACCUCHECK OF 59.  PT STATES HAS NOT EATEN SINCE 7 AM AND HAD EGGS AND SAUSAGE.  PT HAD SECOND COVID VACCINE TODAY AND HAS TAKEN ALL HIS MEDS INCLUDING INSULIN AT REGULAR TIMES.  PT DENIES ANY RECENT ILLNESS. PT WAS RECENTLY HOSPITALIZED 3/5/2021 FOR CELLULITIS AND DECONDITIONING AND IS GETTING HOME HEALTH FOR PT.  3/26/21 Transferred to HOME MEDICAL dx: inferior MI, hypoglycemia, right middle lob pulmonary infiltrate 3/30/21 returning to HOSPITAL for swingbed admission
unspecified number of patients were administered improperly stored doses of GARDASIL 9 or PNEUMOVAX 23; This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.    On unknown dates, patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R036913, expiration date on 23-SEP-2021 and lot #1602283, expiration date reported as 16-AUG-2021, but internally validated as 18-AUG-2021, for prophylaxis or with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #S026366, expiration date on 17-SEP-2020. Vaccines were improperly stored at a temperature of 30.5°F during a time frame of 2 hours and 45 minutes. There was no previous temperature excursions and the call was not because of a data logger.
CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20321A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 10-APR-2021 11:45 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills. This report was non-serious.
she is diagnosed with covid; she is diagnosed with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "she is diagnosed with covid". The patient underwent the following laboratory tests and procedures: she was diagnosed with granuloma anular: granuloma anular, notes: she was diagnosed with granuloma anular; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional Information:  Patient was diagnosed with covid and is taking Paxlovid; stated that she had three booster doses of the Pfizer BioNTech covid19 vaccine and when the transferring agent probed the caller's doses of vaccine, the caller stated she wants to get her 3rd booster of the vaccine. Patient stated that every time she gets a dose of vaccine she gets mouth blisters and ulcers and bleeding gums and this happens every time within 7 days of the dose of vaccine; stated she went to a dermatologist and they told her that was an autoimmune response to the vaccine and she was diagnosed with granuloma anular. Stated this doctor advised her not to take another dose of the vaccine; states the caller's question was in regards to these oral side effects and also wanted some recommendation as to whether to take the 3rd booster of the vaccine or not. Patient wanted to get some information on the Pfizer COVID-19 vaccine. Patient  took three boosters and was looking at oral side effects. Patient currently have COVID which is absolutely nasty. Patient wanted to find out is the incidence of oral reactions like blisters and stuff in your mouth.  Every time I´ve got a COVID vaccine Patient broken out with mouth blisters and bleeding gums. Patient still want and got them all but didn't get my last her booster and patient had three. Physician advised not to get another vaccine. Patient got hit with full force COVID. Patient was on Paxlovid right now, its been seven days and Patient was still testing positive but she don't feel like I'm going to die at least. Patient's concern is this something that has come up before. Apparently this is something other people has experienced." She wants to know this information in order to decide if she should get another booster or not.   Follow-up attempts are completed. No further information is expected.
Pt recv vax on 6/19/98; 2 hr later pt exp nausea, red &swollen right & left face.  Pt tx=oral Benadryl.
Loss of taste; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, AGEUSIA (Loss of taste), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved.        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.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Fever of 99.7; some achiness; fatigue (slept on and off for 36 hours); some soreness at injection site Symptoms lasted approximately 36 hours Took 1 tylenol tablet every 6 hours during the 36-hour period
Moderna COVID-19 Vaccine EUA A week and a day after my first dose, a rash at the vaccination site (upper left arm) formed and is the size of about two quarters and a penny. The rash is raised and extremely itchy. I have not used any new products on my skin lately and this is the only area of my body where a rash has appeared.
Client was given DTaP that expired on 07/07/2019, no adverse events. Client's mother notified.
This spontaneous report was received from a physician via a company representative and refers to a 67-year-old female patient. No information regarding the patient's medical history and drug reactions or allergies was provided. In April or May 2017, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (lot number and expiration date were not provided) reconstituted with sterile diluent (MERCK STERILE DILUENT) (reported as "water sterile diluent"). On the same day (reported as "hours after administration"), the patient developed a rash around the injection site, which on the next day spread towards the patient's chest. The events were treated with an unspecified dose of prednisone (manufacturer unknown). The patient recovered from the events on an unspecified date in 2017. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
pt recv vax 24JUL96 & 5JAN98 pt devel chickenpox;