chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Got shingles 2-3 times; Fever; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, fever and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the fever and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received second dose of Shingrix vaccine 4 months ago and got shingles 2 to 3 times. He also had fever and felt achy which resolved in 2 to 3 days. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Patient was administered monovalent vaccine instead of bivalent; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of bivalent) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035B22A) 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 WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of bivalent) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of bivalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered monovalent vaccine instead of bivalent).    No concomitant medications were reported.  The patient received 2 primary Moderna doses and 1 Moderna booster. No adverse reaction was reported.  No treatment medications were reported.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 20-OCT-2014, an unspecified number of patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Received PPSV23 on her left deltoid yesterday around 12:30 pm. The arm hurt when she left, just felt achy. Noticed that it was starting to swell around 2 pm. By 6 pm, when she got home, it was very swollen, hot. She took 2 tylenol, put ice on it. The swelling has gone down since yesterday. Will continue to ice and provide supportive care. Denies rash, denies any difficulty breathing.
"Started to have  a rash on rt side of  her face, along  with dizziness, weakness and tingling in her rt arm. Rapid response  team called and came, RRT took her to ED"
1/29/2022-ITP: Patient presents with severe low back pain and petechial rash on admit platelets were 10 and rash on extremities and buccal mucosa.  Started pulse dexamethasone and 40mg daily for 4 days then 10 mg prednisone daily. Received IVIG one time.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown whether patient has diagnosed/tested positive for COVID-19. It was reported acute illness at the time of vaccination and up to one month before and chronic or long-standing health conditions were unknown.     On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 72 years and 4 months. No concomitant medication information was provided.  The vaccine was administered beyond use date after the thaw process. Patient received Moderna COVID-19 vaccine for dose 1. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines.   Vaccine number 1 code was reported as 80777-0273-99.  No treatment drug information was provided.
PATIENT STATES  AND SHOWS FLUSHNESS TO BOTH CHEEKS (BRIGHT  PINK).  DENIES ITCHING, BURNING, OR ANY OTHER SYMPTOMS. PATIENT ALSO STATES THE FLUSHNESS IS THE ONLY ISSUE AT THIS TIME.
per patient - she started having severe shivering the night after getting shot and went to the ER. They gave her blankets and shivering stopped after 3 hours. She is back at home and reports no other symptoms. She has spoken with her primary care
she got first dose of vaccine on 11Jan2021/did a Covid test last Friday, 29Jan2021, states she was positive for Covid; she got first dose of vaccine on 11Jan2021/did a Covid test last Friday, 29Jan2021, states she was positive for Covid; This is a spontaneous report from a contactable consumer reporting for herself.  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL1283), via an unspecified route of administration in right arm on 11Jan2021 (at the age of vaccination of 77-year- old) at single dose for COVID-19 immunization. Medical history included diabetes (controlled, diagnosed about 8 years ago). No concomitant medication was reported. Patient reported that she has not taken any medicine only a little Tylenol if she has a little headache or something. Patient informed that, after receiving the vaccine her daughter visited her a week later for 30 minutes and then told her she tested positive for COVID 19. On 29Jan2021, patient got tested for COVID 19 and she too was positive for COVID 19. She had no symptoms of COVID 19 and was told to quarantine for 10-12 days. She is scheduled for second dose of vaccine on Tuesday and would like to know if she should receive second dose of vaccine on Tuesday. Outcome of events was unknown.
Upper respiratory symptoms nasal congestion bowel problems ill taste for food lack of appetite food smelled like ammonia.
ringing in the ears; This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number B4TT5, expiry date 10th April 2022) for prophylaxis.   Co-suspect products included pneumococcal vaccine polysaccharide 23 valent (Pneumovax) for product used for unknown indication.   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular) and Pneumovax at an unknown dose and frequency. On 26th February 2020, 3 hrs after receiving Shingrix, the patient experienced ringing in ears. The action taken with Pneumovax was unknown. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Pneumovax experienced ringing in the ears.
heart rate was going up; and was on a resting rate but it was going up; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 06Jun2021 07:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jun2021 the patient experienced heart rate was going up; and was on a resting rate but it was going up. The patient underwent lab tests and procedures which included heart rate: 124 on Jun2021 it was going up to like 124, 131, 124, 128, 133 and I just got scared, heart rate: 131 on Jun2021, heart rate: 124 on Jun2021, heart rate: 128   on Jun2021, heart rate: 133 on Jun2021.The outcome of event was unknown.
Gradual loss of use of vaccinated (left) arm Increasing pain in shoulders/neck area & pelvic girdle Eventual loss of ability to stand from sitting position & loss of function of left arm  02/11/2022 ER Visit local clinic -6 day prednisone taper given-symptoms lessoned till end of taper  02/11/2022 local Urgent care- 15 mg prednisone prescribed-symptoms lessoned 03/05/2022 local Urgent Care- prednisone prescribed 03/07/2022 local Health Neurology- Polymyalgia Rhuematica diagnosis 03/10/2022 local Health clinic- 15mg prednisone prescribed 04/07/2022 local Dr.- 3 month prednisone prescribed
Patient received Tdap, MENVEO, and GARDASIL on 7/10/18. She had been very anxious prior to receiving vaccinations. Within 2-3 minutes following vaccination, the patient felt nauseous and had an episode of syncope. She was sitting on the exam table with mother; the mother had her arm around patient after vaccination (she had been instructed to remain seated for 15 minutes following vaccination). Patient fell off the exam table before mom could catch her when she became faint. She hit her head on the floor, causing bruising and contusion on the right side of her forehead and face. Dr. assessed her following episode of syncope and injury. Nurse followed up with mom via phone the following day (7/11/18) and patient was doing well; no concerns at that time.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Gadolinium, reaction(s): "known allergies gadolinium", notes: known allergies gadolinium; Levaquin, reaction(s): "known allergies levaquin", notes: known allergies levaquin; Tobramycin, reaction(s): "known allergies tobramycin", notes: known allergies tobramycin.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 7OCT98 & 9OCT98 c/o rash & pain in lt arm to elbow;no warmth to touch;no swelling;rash spread to other arm;
DIED AFTER RECEIVING YOUR VACCINE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On 14-APR-2021, the patient died after receiving vaccine and cause of death was unknown. It was unspecified if autopsy performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210710773-covid-19 vaccine ad26.cov2.s - DIED AFTER RECEIVING YOUR VACCINE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
A slightly raised red rash appeared near the injection site a week after the first shot. The size of the rash was about 4 inches by 2 inches and expanded a little bit in the first 2-3 days after its appearance. The rash caused some mild itching. It started to fade on the 4th day and disappeared on the 6th day without any medication/treatment.
Client was given FLUMIST  - MedImmune H1N1 live vaccine. Client is 10 wk pregnant. 12/01/09  Received prenatal Medical Records for DOS 11/16/09, 11/20/09, 11/25/09
Initially, I had some tingling in the tip of my tongue and some chest tightness.  That passed  for the most part and I felt fine until 5pm when I started to feel extremely nauseous, with generalized aching, chills, temp of 99.8, and extreme exhaustion.  These symptoms continued through today when I also started having dizziness.   Symptoms were treated with motrin and zofran.
This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
IMMUNE TO EVERYTHING/ CURED LIVER ISSUES/INVINCIBLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced immune to everything/ cured liver issues/invincible. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immune to everything/ cured liver issues/invincible was not reported. This report was non-serious.
Low grade fever, blister like bumps all over. Treated with Benadryl and Calamine lotion.
redness of the injection site still getting bigger; Injection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site was warm to touch) and INJECTION SITE ERYTHEMA (redness of the injection site still getting bigger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site was warm to touch). On 17-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness of the injection site still getting bigger). At the time of the report, INJECTION SITE WARMTH (Injection site was warm to touch) and INJECTION SITE ERYTHEMA (redness of the injection site still getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment The patient has took Tylenol, Benadryl, and Keflex for a week. Nothing seems to be helping.
Patient reports beginning to develop itchy rash to upper body approximately 6;00 the following evening 08/14/2021 after vaccination (33 hours). She has been taking claritin to help with itching. Denies any other new exposures in home, or medications. Nobody else at home having issues. Presents today 08/18/2021 with continued pruritic rash to upper body (chest, bilat arms, back, neck area) feels like her eyes are swollen.
Ringing in both ears (tinnitus?) which is worsening each day. No treatment or outcomes.
Information has been received from a physician concerning a 19 year old single female who on 19-JUN-2007 was vaccinated with the first dose of GARDASIL (Lot # "0389U"), on 23-Aug-2007 was vaccinated with the second dose of GARDASIL (Lot # 658488/0930U) and on 03-Jan-2008 was vaccinated with the third dose of GARDASIL (Lot # 658558/1061U). The patient had an abnormal PAP test since receiving the vaccinations. The patient needed a colposcopy. The patient did not have a positive PAP test prior to receiving the vaccinations. Medical attention was sought in the office. Patient outcome was unknown. No product quality complaint was involved. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 3/14/2008.  No further information is available.
I had vertigo, headaches, fever off and on the next day. On April 23, 2021 I called emergency came out to my house checked my blood pressure, temperature, oxygen level and the episode had passed I didn't go to the ER. Since then my blood pressure has been higher than normal. It was 115/75 before vaccine now 140/95. For the headaches I take Tylenol. My doctor didn't want to treat my headaches until I got my gallstones removed.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pharmacy administered vaccine & followed normal routine, including keeping a hand on pt the whole time until finished pt slumped over & rolled to his left & rolled out of chair onto the ground, on his stomach. He didnt hit the wall or the chair.  Father & I both knelt to ground to roll him to his side and he immediately came to & sat up against wall. Dad said he had not had anything to eat any time recently, unconcerned & proceded to move to the next child, who was too scared to do it.
Sore arm (this was the only side effect I had from shot #1) - soreness from shot #2 began 3:00 pm. Became cold about 6:00 pm -sweaters/ blankets did not help. Took my temperature - it was 101 degrees. My blood pressure was slightly elevated. Took 2 BENADRYL and 3 ibuprofen.
MISTAKENLY GAVE AN ADULT HEP A VACCINE INSTEAD OF A PEDIATRIC HEP A TO PATIENT.
headache with nausea and vomiting lasting 8-9 days not relieved by triptans or ibuprofen or Tylenol.
Post vaccination expressed feelings of nausea, dizziness, and syncope.  Did not pass out, recovered and left ambulating independently with male companion.
She explains that she has had loose stools and is going all day long to the bathroom; terrible stomach cramps; stomach upset; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266) via an unspecified route of administration at right arm on 13Feb2021 10:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications reported as none. On 23Jan2021, the patient received her first dose. Patient stated that after she received her second dose of the Pfizer BioNTech COVID-19 vaccine, "a week and a half or 10 days later" experienced "terrible stomach cramps and loose stools" and they "feel like menstrual cramps. Patient states that after she received her first dose of the vaccine, she experienced these same symptoms so she stopped eating fruits and vegetables and stopped taking her vitamins to see if they were the cause; however, after the second dose she again had these symptoms. She explains she was getting better but then after the second dose the events came back in full force. She explains that she has had loose stools and is going all day long to the bathroom. She has never had this problem, actually always has the opposite problem. She wants to know if we have had any other reports like this. The stomach cramps are almost like mensural cramps all day long. She also has stomach upset and every time she eats, it goes right through her. Treatment: It was explained that she has not reported this to the doctor. Caller state she has just been dealing with the side effects. Caller did not mention testing positive for COVID during the call, only that this only happens when she has a virus. The outcome of the events was unknown.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VAQTA, for prophylaxis (dose, route of administration, lot# and expiration date were not reported). Administered dose of VAQTA was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on unknown date. Digital date logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.