chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms during the 12 hours post injection; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 12 hrs after receiving Shingles vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received shot for the Shingles vaccine. The patient needed to get  second shot.  The 6-month window was now closing in for the patient. The patient was hesitant to get the shot as the first one produced flu like symptoms during the 12 hours post injection. The reporter wanted to know was it ok to wait a little longer past the 6 month or should he/she do it now.
Pain in shoulder; given in tendon/bursa as noted by MD. Inflammation noted by MD also. Patient treated with 800mg Ibuprofen and tramadol for pain; also range of motion issues.
Indication=Treatment of COVID-19; Indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; CRESTOR; OMEPRAZOLE; METFORMIN. Past drug history included: Phenobarbital, reaction(s): "Known allergies: phenobarbital", notes: Known allergies: phenobarbital; Fluconazole, reaction(s): "Known allergies: fluconazole", notes: Known allergies: fluconazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (10Sep2022) Negative, notes: after ending Paxlovid and testing negative for two days; (11Sep2022) Negative, notes: after ending Paxlovid and testing negative for two days; (12Sep2022) Positive, notes: I started testing positive after two days; (13Sep2022) Positive, notes: I'm still testing positive 5 days after ending Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks was Yes. Paxlovid treatment start date was 04Sep2022, treatment stop date was 09Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Localized reaction on the left arm immediately after injection. "Sized reaction immediately/instant following injection." The size was about ~1 inch in circular formation.
ADMINISTRATION ERROR / DEVIATION; INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUN-2021, the subject experienced administration error / deviation. On 29-JUN-2021, the subject experienced inappropriate dose of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error / deviation and inappropriate dose of vaccine administered was not reported. This report was non-serious.
Developed severe right leg pain, small rash on my right buttocks, tenderness at the LS joint, subsequently diagnosed with shingles on 1/7/21
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 30th March 2019, the patient received SHINGRIX (intradermal). On 30th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and intramuscular formulation administered by other route. On 31st March 2019, the patient experienced feeling unwell and diarrhea. On 2nd April 2019, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site itching were not recovered/not resolved and the outcome of the injection site swelling, feeling unwell, diarrhea and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema, injection site itching, feeling unwell and diarrhea to be related to SHINGRIX. Additional case details were provided as follows: The patient was vaccinated with the dose of SHINGRIX subdermally between the elbow and deltoid and dose was administered in the wrong site, which led to intramuscular formulation administered by other route. After the injection, the patient experienced pain at the injection site, swelling and erythema. The next day, the patient did not feel well and experienced diarrhea. At the time of report, the symptoms related to the injection site were ongoing and now the patient experienced the itching at the site. No additional details reported.
This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date; varicella virus vaccine; manufacturer unspecified; unknown given on an unspecified date. On either 28 March 2011, 29 March 2011, 2 April 2011, 8 April 2011 or 13 April 2011 the subject received unspecified dose of KINRIX (unknown route, unknown arm). Less than one month after vaccination with KINRIX, the subject experienced injection site inflammation, swelling injection site and injection site soreness. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that 7 children experienced the same side effects after receiving KINRIX vaccine. The vaccine was administered on 28 March, 29 March, 2 April, 8 April, and 13 April 2011. This is case 7 of 7; see case IDs A0924034A, A0924036A-A0924040A for details of the other reports.
Beginning 72 hours after the injection, intermittent ringing in the ears. Mild, low volume, and easy to tune out. Infrequent for the next 3 days. Beginning on day 8 after the vaccination, loud persistent ringing in both ears that can't be tuned out. No treatment started yet.
thrombocytopenia/After second dose, platelet count on 9/23/21 was 21000; Recurrent ITP; Recurrent ITP; This is a spontaneous report from a contactable other HCP (nurse) who reported for a patient.  A 31-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 20Sep2021 (Lot Number: 301308a) at the age of 31-year-old, as dose 2, single for COVID-19 immunization. The vaccine was administered at Pharmacy or Drug Store. 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 and since the vaccination, the patient has not been tested for COVID-19. Medical history included Immune thrombocytopenic purpura (ITP). The patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Lot number=FC3184), administered intramuscularly on 29Aug2021 at the age of 31-year-old as dose 1 single for COVID-19 immunization. The patient experienced thrombocytopenia/after second dose covid shot. Platelet count on 17Sep2021 was 141000. After second dose, platelet count on 23Sep2021 was 21000. The patient had recurrent ITP on 23Sep2021 after Covid vaccination. The events were reported as non serious. The events resulted in Doctor or other healthcare professional office/clinic visit and required treatment with Rituxan. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Thrombocytopenia, Immune thrombocytopenic purpura and Disease recurrence.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
On May 13th, I felt my feet go numb and I could not stand. I sat down to immediately find a heat go through my bod - heat to head. I then felt my heart racing. Took my pulse and it was 134. (I have had no heart issues at all previously - normal resting heart rate in the 60s). Three more times this happened, with heat going from feet to head (numbness in feet).  Each heart rate was progressively lower with each incidence.  Then it stopped. This was in the afternoon and by evening felt ok.   The 14th, the same thing happened but only 3 times and with hr incidents starting at 123.  Then fine again.  The morning of the 15th started again, so I went to urgent care appointment in the afternoon. By this time, my heart rate was up and down..  They ran an EKG and it was fine, just showing rapid heart rate. But I was sent to the ER for further tests.  At  ER another EKG, chest x-ray and blood work.  Only item of significance was an elevated TSH.  At this point, my heart rate was going up and down (I had a finger monitor so I could watch it).  I'll note at this point, the heart rate was random but I was able to walk. Over the next week or so, hr got worse and positional. When I stood up, it would sky rocket to the 140s.  I became shaky, developed brain fog, nausea, feeling like I was going to fall over and felt only well laying down or sitting.  I visited my primary who initially thought anxiety but as symptoms were getting worse (I could no longer do anything: walk farther than from the living room to the kitchen, do simple tasks while standing or sitting - hr would increase while doing activities even while sitting, and no longer drive).My doctor decided it was more than anxiety when I was continuing to have symptoms that looked like POTS. I have been to the cardiologist - she  did a 24 holter and EKG - no significance, but decided my heart was not the primary cause of the positional heart rate increase.  I am due for an echocardiogram this week - just to make sure but she did not think that was the issue. An MRI this week, recommended by my neurologist. and have done preliminary blood work/urinalysis for possible endocrine issues - all that have come back normal so far (but seeing an endocrinologist next month anyway).  I currently am seeing functional neurologist who has diagnosed me with dysautonomia  (so far of unknown reasons) - he is helping me with the heart rate issue (POTS) and other symptoms that have developed over the weeks like electrical zaps throughout my body - some sort of neruopathy. I was in great health until this shot.  I had not even had a cold since January of 2020.  I may have hypothyroidism but it has been managed with some ups and downs in TSH for the last 20 years with no other issues.   Some of my doctors do not correlate the shot to my problem but some have.  There does not seem to be any other explanation.
This spontaneous report as received from a physician refers to a 12 year old female patient. On 27-SEP-2012 the patient was vaccinated with GARDASIL dose 1, intramuscular. Dosing information and lot number were not provided. On 27-SEP-2013 the patient received her second dose of GARDASIL. Dosing information and lot number were not provided. No adverse effect was reported. Additional information is not expected.
my arm hurt for 4 Hours later and peaked that evening; headache; tiredness; lethargic/pretty lethargic.; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). Contactable Physicians (one was patient) reported that a 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021) on 18Dec2020 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. The caller is a MD. He had the vaccine on Friday. His arm hurt 4 hours later, and then peaked that evening. It was very painful. It hurt and was painful. By Sunday it was 95 % gone. Today (21Dec2020) the pain is completely gone. He received the vaccine Friday. He is supposed to get an MRI Wednesday morning. He will be getting Gadolinun. He wanted to know if there was any adverse reaction with that. Will this material interfere with the immune response of COVID vaccine? He is considering canceling his MRI. The caller confirmed the details provided by the transferring agent. He doesn't have a prescribing doctor. He was looking at his CDC vaccination record log. He was given 0.3cc. He received the injection, and the pain started 4 hours later. It peaked in the evening. It was the worst arm pain he has ever had from a shot. He couldn't elevate his arm from pain. It was interesting because there was very little heat at the injection site. The amount of arm pain was not proportionate to a local reaction. He did take Tylenol that night. He got up the next day, Saturday, and it was painful but a little less painful. Then on Sunday 20Dec2020, it was 95% essentially. He started to get lethargic that Friday at about 9-12 hours later. Then he had a headache about 11 hours later that lasted 5-10 minutes. He was surprised but it went away. Saturday, he was pretty lethargic. He felt more lethargic from the shingles shot. No details on the shingles shot provided by the caller. He said the tiredness may have been a placebo effect because everyone says you will get tired. He was fine yesterday and today. He is glad he got it. He has recovered completely from all side effects he had. He never had a fever. His question about the MRI was escalated by the Medical information associate.  Follow-up attempts have been completed and no further information is expected.
March 15th: Day 2 after vaccine: noticeable shortness of breath when walking  March 17-18:  Days 4 and 5 after vaccine: extreme fatigue/exhaustion March 20-24: Burning chest pain, pain in jaw, continued shortness of breath when walking and fatigue March 24: Went to doctor, D-Dimer = .51 March 25: Chest X-ray to rule out pulmonary embolism. No pulmonary embolism found. Enlarged lymph nodes on left side found. April 4: After 1/2 mile walk was exhausted. Experienced loss of strength in both hands, but more so in right hand. Experienced "general feeling of doom/unwellness" previously associated with seizure due to oligodendroglioma. April 3: Follow up with doctor. Suggested my brain tumor (oligodendroglioma) may be growing. April 6th: MRI. Tumor had not grown. April 7th: Meeting with oncologist who did not feel symptoms were due to tumor growth. Suggested possibility that vaccine could have triggered breakthrough seizure. Increased seizure medication in mornings from 50 mg Vimpat to 100 mg Vimpat.  Sent me to my regular doctor. Met with regular doctor, who didn't think symptoms were due to the vaccine, but didn't know because it was so new. Did bloodwork. Severe fatigue in afternoon. April 10th: Was scheduled for 2nd vaccine, but did not feel well enough to get it. April 12th: All bloodwork normal except high LDL (but good ratio with HDL), high TPO (thyroid antibodies). Still fatigued. April 11-17: Fatigue gradually improving. Shortness of breath going away. Stamina returning, gradually. April 18-19: Feeling much better. Able to walk. No shortness of breath.
Treatment of COVID-19; Treatment of COVID-19; Pfizer/BioNTech, Date: 23Oct2021; Modern, Date: 06Feb2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 78 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 027L20A), in right arm and on 06Feb2021 as dose 2, single (Lot number: O16M20A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "microscopic colitis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "scoliosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Pfizer/BioNTech, Date: 23Oct2021; Modern, Date: 06Feb2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 26Dec2022 to 01Jan2023 as treatment of COVID-19. The patient had no known allergies.
The patient reports experiencing "dead arm" since he received the vaccine.  He says that he was fine after the first dose, but that his arm has not felt the same since he received the second dose.  He describes it as "dead arm" and says that he can still feel tightness at the exact spot where he received the shot even though  a month and a half has passed.
15 month old patient was given DT and not the prescribed Daptacel,with no reported adverse event; Initial information received on 11-Apr-2022 regarding an unsolicited valid  non-serious case received from health professional and Physician.  This case involves a 15 months old male patient who experienced 15 month old patient was given DIPHTHERIA AND TETANUS TOXOIDS (dt) and not the prescribed daptacel,with no reported adverse event.  This case is linked to case 2022SA128715(Companion Case).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 08-Apr-2022, the patient received a  dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer at dose 0.5 ml once lot C5733AA via intramuscular route in right thigh for Prophylactic vaccination.  On 08-APR-2022, it was reported 15 month old patient was given dt and not the prescribed daptacel,with no reported adverse event (wrong product administered) latency same day following the administration of DIPHTHERIA AND TETANUS TOXOIDS.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   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 the guidelines. 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.
This case was reported by a nurse via sales rep and described the occurrence of swollen tongue in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced swollen tongue. The patient was treated with BENADRYL. On an unknown date, the outcome of the swollen tongue was recovered/resolved. It was unknown if the reporter considered the swollen tongue to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported by a nurse practitioner. No other vaccines were given on that day. The date of vaccination was not known by the representative. Limited information was provided by sales representative.
Difficult to determine if this event was related to vaccination.  46 y.o. male with a pertinent interval and past history of HTN, sponge kidney, ckd, gerd and HLD.  Presents to ED with worsening redness and tenderness of his right upper mid thigh.  Patient states that he got the Pfizer vaccination yesterday second shot evening and then developed some subjective fevers sweats and chills.  Also had myalgias this all lasted approximately 2 hours but he was able to get to bed and fall asleep.  Woke up this morning feeling better but still with some chills but noticed some tenderness and redness in his right upper mid thigh.  This got progressively worse.  Continues to have chills but improving.    ED work-up including CBC unremarkable, CMP with mild hyponatremia and hypokalemia of 134 and 3.4 respectively.  ED drew blood cultures and then started vancomycin.  Vitals normal and stable in ED.  Admitted to hospital.  Provider notes on 2nd day of admission as follows.  Cellulitis and abscess of the right medial thigh likely secondary to a skin tag tear which introduced infection.  Patient currently is on broad-spectrum antibiotics in the form of doxycycline and vancomycin.  Unfortunately, the patient has been eating just ate lunch and also has been getting Lovenox.  He is not going to tolerate a bedside incision and drainage.  We will plan on proceeding to the operating room tomorrow for quick I&D and cultures.  Procedures been explained.  The wound will need to be packed afterwards and ultimately healed in.  Patient seems understand plan and we will proceed accordingly
Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Patient had the full dose for 1st booster, though. That was before they said it was a half dose. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.) 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 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.). At the time of the report, ACCIDENTAL OVERDOSE (Patient had the full dose for 1st booster, though. That was before they said it was a half dose.) outcome was unknown.            No concomitant medications were reported. Patient took first and second dose of unknown vaccine and patient was not immunocompromised. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow-up received contains no new information.