chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Information regarding patient's medical history, concurrent conditions, concomitant medications and past therapies were not reported. On 03-APR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N013268, expiry date: 25-OCT-2018 for prophylaxis whose dose and route of administration were not reported. The PROQUAD administered was reconstituted with properly stored Merck sterile diluent of unknown lot number and expiry date. On an unspecified date, the measles, mumps, rubella and varicella (oka-merck) virus vaccine live was subjected to a temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit (9 degree Fahrenheit) for the time frame of 2 hours which was noted from a data logger. No adverse effect reported. It was reported that there was no previous temperature excursion. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1804USA002248.
Patient received FLUZONE in our outpatient center- had office visit only, so received IM injection in MD area. Patient called 2 hours later stating tongue swelling, cough, and throat itching. Instructed to take BENADRYL and go to the ED. Patient was admitted. Waiting to hear condition.
Approximately 4 days after my Pfizer vaccine my body broke out in severe hives(urticaria). The rash  is focused on upper legs and abdomen with addition spots on hands, elbows, upper, arms, neck and back. The areas of my hands and wrist burn and are also stiff. My eye lids  also became swollen .
Shingles, got the vaccine, had a bout with it a few months go/Suspected vaccination failure; shingles; Pain is ridiculous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 Information: GSK receipt date :26-SEP-2022 Reporters comment: This case was reported by a patient via interactive digital media  The patient received the Shingle vaccine and had a bout with it a few months ago from reporting. The patient stated that the pain was ridiculous and if she was not already on a pain management program for something else, she could not imagine how it could be any worse. She had her husband take pictures daily to see how bad it gets. Additional Supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
c/o feeling dizzy, ringing of the ears. Patient put in tredelenburg. Blood pressure 106/68. AFter 15 minutes, patient symptoms resolved. Discharged.
Bleeding at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number GE9S7, expiry date 21st September 2021) for prophylaxis.   The patient's past medical history included injection site hemorrhage (due to some other injections).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th June 2019, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: Reported batch number GE9S7 pertains to Shingrix adjuvant. On the day of reporting, the patient experienced some bleeding after receiving 2nd dose and bandage was applied on it. The reporter consented to follow up.
PATIENT RECIEVED VACCINE IN SEPTEMBER AND HER ARM IS STILL PAINFUL. SHE STILL HAS A "KNOT" ON HER ARM AND STILL CANNOT FULLY EXTEND HER ARM UPWARDS. SHE STATES THE PAIN IS WORSE AT NIGHT AND THAT IT SEEMS TO RADIATE TO DIFFERENT AREAS.
Fasciculation in face  arms and legs. My son started having these twitches within 2 hours of the first dose of the vaccine.  He is still intermittently experiencing twitching of the face, arms and legs with no other medical reason.
Local erythema/swelling of upper arm (left) limited ability to move extremities for about 24 hours. Couldn't get up out of bed. Had to use a cane the next day to walk around. Resolved in about 24 hours.
Immediately after I had fever, chills, muscle pain for 48 hrs but the neck pain and migraine headache have been persistent for two weeks. I have been seen in the Urgent Care and provided with muscle relaxers. No help. Went to the ER and was given migraine meds and CT scans/blood work(all normal). No help. I?ve consistently  taken ibuprofen/Tylenol/ Excedrin. No help. Tried the chiropractor and a massage. No help. Tried a low dose of steroids. No help. Tried oils/muscle relief gels/heat/ice. No help. I am typically a very active, healthy, take no medication and run and work our daily type of person. In the last two weeks I can barely manage my normal daily activities without any exercise or the things I enjoy. It hurts so bad I spend so much time in bed. I?m upset by this, I had Covid in January and was fine. I worked out the whole time I had it. I don?t know what else to do. I?ve seen no improvement.
Two days after shingles 10/29/14 patient had a red rash at injection site a few inches that was hot to the touch. Told her to go to doctor in case of infection. Was given steroid and antibiotic 10/30/14. At 7:00PM 10/30/14 patient stated she feels better.
Diarrhea; Vomiting; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: fr8727), via an unspecified route of administration into the left arm as a single dose on 23Mar2021 at 14:00 for COVID-19 immunization. Medical history included diabetes. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, cupric oxide, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium selenate, thiamine mononitrate, zinc oxide (ONE A DAY WOMEN'S), taken for an unspecified indication, start and stop date were not reported; metformin (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (B 12) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, valsartan (DIOVAN HCT) taken for an unspecified indication, start and stop date were not reported. No noted allergies to medications, food, or other products were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced vomiting on 24Mar2021 and diarrhea in May2021 date. Details were as follows: Vomiting was noted 18 hours after shot. Diarrhea was noted the next day. No treatment was given for the events.  The clinical outcome of vomiting and diarrhea was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date).    No Concomitant medication was reported.  It was reported that 2 patients received a Moderna COVID-19 Vaccine on 13Feb2023 after manufacturing expiration date. Vials expired on 11Feb2023. No AEs were reported. Caller did not have any patient demographics but stated patients were children.  No treatment information was provided.  This case contains information for the 2nd of 2 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-710266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710266:Master case
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 14th October 2022, the patient received Havrix. On 14th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Reporter reported that a dose of Havrix was given after the expiration date. It was expired on 30th September 2022.  The vaccine administration facility was the same as primary reporter. Reporter consented to follow via email. Additional supportive information: The patient administered expired dose of Havrix, which led to expired vaccine used.
arm pit lump; Side effects; This case was reported by a consumer via call center representative and described the occurrence of axillary lump in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse reaction (for 1st dose, refer case US2019136512).   On 22nd July 2019, the patient received the 2nd dose of Shingrix. On 22nd July 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction. On 26th July 2019, the patient experienced axillary lump. On an unknown date, the outcome of the axillary lump was not recovered/not resolved and the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the axillary lump and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix 4 days before the date of reporting and had 3 days of the side effects, and on the day 4 (day of reporting) had a lump in his arm pit. The reporter did not give consent to follow up. The patient refused to provide any further details regarding this adverse event at the time of reporting. The patient stated he would like his personal information to not be a part of this report.
Patient received vaccine on 9/18/19  on 9/20/19 morning patient noticed 4" round circle  2" below injection site, circle was red, raised and warm to touch. Patient's whole are was painful to touch. Patient called physican and was seen the afternoon of 9/20/19. Physician said cellulitis or allergic reaction. Patient used bacitracin and swelling has gone down.
I was gagging to throw up this green stuff that came up but it was not watery because I did not have too much of a stomach; Wheezing; Coughing; chest is very congested now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 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. Vaccination history included: Covid-19 vaccine (Dose: 1), for COVID-19 immunization; Covid-19 vaccine (Dose: 2), for COVID-19 immunization; Covid-19 vaccine (Dose: 3), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 03Dec2022, outcome "unknown", described as "Coughing"; RETCHING (non-serious) with onset 03Dec2022, outcome "unknown", described as "I was gagging to throw up this green stuff that came up but it was not watery because I did not have too much of a stomach"; WHEEZING (non-serious) with onset 03Dec2022, outcome "unknown"; RESPIRATORY TRACT CONGESTION (non-serious) with onset 03Dec2022, outcome "unknown", described as "chest is very congested now".  Additional information: Consumer stated, patient just wanted, patient had his fourth shot yesterday the COVID shot(Clarified as Pfizer COVID vaccine) yesterday at withheld and patient woke up this morning was gagging to throw up this green stuff that came up but it was not watery because did not have too much of a stomach so whatever happened, you know wheezing and coughing you know that chest was very congested and it was not yesterday before this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tenivac left in the freezer for 20 minutes, No AE; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a female patient of an unknown age.  This case involves temperature excursion of the DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U663AA, expiry date: 12-APR-2022), which had occurred due to vaccine left in the freezer for 20 minutes (human errors) was detected and declared on an unknown date (vaccine indication is prophylactic vaccination).  It was a case of a potential medication error due to product storage error temperature too low.  At the time of reporting it was unknown if vaccine was administered to the patient or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
high fever; vomiting; This is a spontaneous report from contactable Physician via a Pfizer Sales Representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization and meningococcal vaccine conj (MENINGOCOCCAL CONJUGATE), via an unspecified route of administration on an unspecified date at unspecified dose for immunization at same visit. The patient's medical history and concomitant medications were not reported. The patient experienced high fever and vomiting on an unspecified date after use of products with outcome of unknown.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Three hours post vax, the pt developed hives on her arms and chest. She was without shortness of breath. No treatment was given.
INR had been stable several months (11/30/11 INR = 2.6). Zoster vaccine administered 1/6/12. INR rechecked on 1/11/12 (1.6). A one-time extra dose of warfarin 5mg taken. 1/23/12 INR = 2. No other changes had been made (diet, etc.) except for the zoster vaccine administration. Symptoms: Abnormal INR. Treatment: Warfarin 5 mg once.
Pt reported allergy manifesting in hives which appeared 3 days after she got the vaccine. She is having the Moderna booster today (12/13/21) and will be monitored for 30 minutes after vaccination, according to protocol.  No reaction to Moderna noted in chart.
pt recv vax 11APR96 & 5 days p/vax running fever of 101.0 x 2 days;progressed to runny nose, coughing, eye infect, ear infect;fever of 102.5 started 22APR96, red rash all over body & today has hives all over body
Feel like you got hit by a truck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a 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 feeling bad (Verbatim: Feel like you got hit by a truck). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient highly recommend to get the vaccine the day before you have a day off, especially the 2nd one. The patient stated that, you may feel like you got hit by a truck. The patient give this advice to everyone and they have all thanked her/him after they got the vaccine. still better than shingles tho. The follow-up could not be possible as no contact details were available.
Had a slight headache the night of vaccination, but about an hour after getting up the next morning, extreme body aches made it difficult to even walk. Every bone, joint, and muscle was sore all day (despite alternating doses of Tylenol and Aleve) until about 8:00 pm when it started to subside. My temperature was also elevated, but no in fever range. I didn't have a true headache, but it felt like my head was going to explode, kind of like a bad sinus infection, but throughout my whole head. Slight headache this morning, but the body aches have gone away.
Awoke with the the room spinning, dizziness, headache, brain fog, vertigo, fatigue.  I have had these symptoms for over 2 months now. Have reported it to my doctor and 2 neurologists. On going.  Taking Tylenol,  Naproxin, Aspirin, Motrin for relief. Also take Dramamine to help with dizziness.
TIRED; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male 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: 1805029) dose was not reported, administered on 19-MAR-2021 10:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced tired. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and tired was not reported. This report was non-serious.
The patient received their vaccination then they waited outside the pharmacy for 15 minutes then went to eat within the store. After eating while walking around the store, the patient felt dizzy and began to pass out. The husband who was walking with her helped her to the ground. The patient remained unconscious for a couple minutes. Breathing and pulse were noted. 911 was called and paramedics examined the patient after she awoke. She was unable to establish place and time upon examination. She was then taken by paramedics to the hospital.
Information has been received from a registered nurse concerning a 28 year old white female with cephalexin allergy and codeine allergy who was vaccinated at approximately 10am with a first 1ml dose of hep b vaccine recombinant give IM in the left deltoid. Concomitant vaccination included a second dose of varicella virus vaccine given SC in the right deltoid. Subsequently, one hour later at approximately 11am, the pt returned to the ER after developing symptoms that made her hot, sweaty, and weak. The pt received on dose of Benadryl. The ER report stated that the pt was treated for an allergic reaction to an unspecified allergen. On 03/02/2001 the pt recovered. Upon internal review, the pt's allergic reaction was considered an other important medical event. No further information is expected.
This medically confirmed spontaneous report (initial receipt 19-Jun-2015) concerns a patient. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not provided). On an unspecified date, the patient experienced facial paralysis after receiving an unspecified flu vaccine. No additional information provided. The outcome was not reported.
Rash at site of injection, onset - after day 8 of vaccine. 2 distinct patches of erythema, slightly raised. On day 3 after rash developed, there is some central clearing.
I began having a fever around 6:30 the day of the injection. I was having muscle pain,  joint pain amd chills also. Symptoms were not relieved with Tylenol. The symptoms remained for approximately 36 hours
This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age and ethnicity received PREVNAR 13 at single dose and PNEUMOVAX 23 at unknown dose, both via unspecified route of administration for immunization at a hospital. The patient's medical history and concomitant medications were not reported. It was reported that the patient had the pneumonia shot the day before (unspecified date) and the next day, on an unspecified date, the patient experienced a reaction described as feeling weak and diarrhea. The patient did not know if the "pneumonia shot" was PREVNAR 13 or PNEUMOVAX 23, just that she got a "pneumonia shot" (pending clarification). Outcome of the events was unknown. Information on batch and lot numbers has been requested.
Rash appeared 4 days post vax, fever x 4 days, vomited x 2 days post vax including loose stool.