chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in arm; Pain in lips; Pain in tongue; Gums swelling; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm, lip pain, tongue pain and gum swelling. On an unknown date, the outcome of the pain in arm, lip pain, tongue pain and gum swelling were unknown.   It was unknown if the reporter considered the pain in arm, lip pain, tongue pain and gum swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shot with unspecified dose and experienced pain in arm, pain in lips, pain in tongue and gums swelling.
VACCINE INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA; This spontaneous report was received from literature with VITT following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. Blood advances. 29-SEP-2021. This report concerned multiple patients (3) of unspecified age, sex, race and ethnic origin. The objective of this literature was to describe vaccine-induced immune thrombotic thrombocytopenia (VITT) following Ad26.COV2.S vaccination presenting without radiographically demonstrable thrombosis. No past medical history or concurrent conditions were reported. The patients (over 8.7 million) received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 01 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 patients (11 percent) experienced vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia following vaccination. On an unspecified date, unfortunately the patients died. It was not specified whether patients autopsy were performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced immune thrombotic thrombocytopenia (thrombosis) and thrombocytopenia on an unspecified date. The author commented that this literature highlighted the critical importance of knowing Covid-19 vaccine history. The author emphasized as on timely recognition that would be essential to prevent catastrophic complications and would require knowing the patient's vaccine history. This report was serious (Death). This case, from same literature article was linked to 20211004121 and 20211006771.; Sender's Comments: V0: 20211011609- COVID-19 VACCINE AD26.COV2.S- Vaccine induced immune thrombotic thrombocytopenia. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: VACCINE-INDUCED IMMUNE THROMBOTIC THROMBOCYTOPENIA; THROMBOCYTOPENIA
Utilizing cooler to keep punctured vial refrigerated; Expired doses administered to 6 Patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 9:39 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 6 Patients) and PRODUCT STORAGE ERROR (Utilizing cooler to keep punctured vial refrigerated) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported..
Patient complaint of redness and swelling at the injection site and migrate to the elbow area and the affected area feel warm and itchy.
After the administration of the vaccines, patient reported feeling dizzy & having difficulty breathing. Patient was advise to sit down & after the administration of the EPI-PEN patient was no longer flushed. Severity of difficulty of breathing decreased. Pt was still shaking. Paramedics arrived & the pt was taken to the hospital. Before leaving pt had an episode of vomiting.
Hives over entire body, swollen lips, swollen arm and hand. Coarse of action: take anti-histamines to help with symptoms.  Dr. felt that I was outside the window to have a reaction but there had been no other medications or foods that I had not had before.
developed a pimple like rash on her face; developed a pimple like rash on her face; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Caller received 2nd dose of Covid vaccine yesterday and has developed a pimple like rash on her face on an unspecified date. Wondering if this is a side effect of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning her mother (patient), with cholesterol and high blood pressure, and a medical history of breast cancer more than five years ago and bypass surgery. On 03-JUN-2008 (reported as "last Tuesday") the patient received a dose of ZOSTAVAX (Oka/Merck). There were no illnesses at the time of vaccination. Concomitant therapy included unspecified medication for cholesterol and blood pressure. By Thursday, the patient noticed what looked like a bite on her forehead. At on an unspecified time blisters that were itchy appeared on her chin, cheeks, both arms, back, each thigh and one blister in between her breasts. No blisters at the injection site (which arm unspecified). There was no product quality complaint. The patient sought medical attention: patient called her daughter who is a physician. The patient's experiences persisted. Follow-up information has been received from a physician, who reported that the 70 patient on 03-JUN-2008 in the evening was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot #659410/0412X) SQ right side. On the same date in the evening, the patient experienced hives on back and legs and was treated with OTC BENADRYL. The patient's final outcome was not reported. Additional information is not expected.
Information has been received from a nurse concerning an under 26 year old female who was vaccinated with three shot series of GARDASIL. The patient went to the physician's office for her next annual visit and an abnormal PAP was detected. This is one of two cases reported from the same source. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Error: Improper Storage (temperature)-
Skin easily develops rash and itchy patches after little scratching. If left alone, skin returns to normal in about 5 minutes
?Pfizer-BioNTech COVID-19 Vaccine EUA" (1st Dose) Muscle aches, severe head ache,  hot flashes, rash and hives on scalp, back, stomach, arms, legs, face. Treated with topical prescription cream and allergy pills, ibuprophen
Approx. 4 days after first Pfizer vaccination, my ears started ringing mildly. As days went by, the ringing  would fade away them come back a little stronger. At the time of my second dose, I asked one  of the medical technicians if ringing of the ears was one of the side effects, she said "yes" and that if it continued, to consult my primary care doctor. Since then my ringing has been continuous, which after some research of my own, I suspect i have Tinnitus.
Heart palpitations; Other reactions; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions). At the time of the report, PALPITATIONS (Heart palpitations) and VACCINATION COMPLICATION (Other reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-363332 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up document contains non-significant information: updated email id.
Patient administered vaccine after the manufacture's date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture's date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter's address updated.
Nausea; Diarrhea; Fatigue; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient had his second vaccine. The patient was experiencing nausea, diarrhea and fatigue. He had been to doctor and tested for COVID. The patient indicated that same thing had happened on his first dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit.  The patient underwent covid test on an unknown date in Apr2021 and the test result was pending. Therapeutic measures were taken as a result of the events nausea, diarrhea and fatigue. The clinical outcome of the events nausea, diarrhea and fatigue were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch cannot be obtained.
Information has been received from a health professional concerning a patient (7 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Subjective fever, body aches, cough, wheezing, vomiting. Started within 24 hours.
Clt. received MMR and Tdap vaccine at 10:30am today. Called in to our clinic at 1:15 pm today, reporting "a couple of blisters on her lip". No other symptoms, no trouble breathing.  Reassured client, explained to observe for a more generalized rash, or trouble breathing, if she were to experience any of those, call (911) or go to closest emergency room immediately.
Tingling in 2 fingers of her left hand; She had 1-2 days of tenderness in her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in 2 fingers of her left hand) and VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site). On an unknown date, the patient experienced PARAESTHESIA (Tingling in 2 fingers of her left hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. On 10-Aug-2021, VACCINATION SITE PAIN (She had 1-2 days of tenderness in her arm at the injection site) had resolved. At the time of the report, PARAESTHESIA (Tingling in 2 fingers of her left hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   About 1 week patient had tingling in 2 fingers of her left hand.  Patient used ice for her shoulder and was prescribed a 5 day curse of steroids which she had not taken yet.  Concomitant medications was not provided by the reporter   This case was linked to MOD-2021-311159 (Patient Link).
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-DEC-2014 the patient was vaccinated with an improperly stored dose of VAQTA 50unit/ml (lot # J001396, expiration date 02-AUG-2015, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 1 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the highest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Additional Details: immediately after administration of the first pfizer dose, patient started hovering over and saying I'm going down. Before I could respond immediately, he fell face first to the floor and got scraped on his nose and forehead
42 YOF c/o tingling in her face. Refused further treatment. No swelling, rash noted.
SOB, chest pain, fever, night sweats, dizziness, neck pain, headache, axillary lump of the left arm occurred within the first 3 days. Given Toradol 30mg  IM, Ketorolac 30mg/1mL IM, Celebrex Capsule 200 MG. Improvement within two weeks
patient inadvertently received an expired dose of acthib with no reported adverse event; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who had inadvertently received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) for prophylactic vaccination (Immunization).   On 31-Jul-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection)(Lot number- HIB: UJ679AA, DILUENT: U7261AA and expiry date: HIB: 28-May-2023, DILUENT: 07-Apr-2023) (Frequency: Once) (Strength: standard) via intramuscular route in the left thigh for Immunization.  On 31-Jul-2023, the patient had inadvertently received an expired dose of ACTHIB with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  Outcome: 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 regulatory agency. 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.
Hospitalized for 3 days with dehydration-loss of weight. I went down to 71 lbs. Burning rash up and down my arms and chest area - pain - peeling skin on inside of my hands and arms - some pain took 3 weeks to completely cover - started on left side - went to right side.
Red rash on limbs and torso starting on week after 2nd dose of moderna. I was fine after the first dose- no reaction.
Sugar spiked off the charts. Had to take triple my normal insulin amount and still could bring down below 300. Also, feel tired, lethargic and achy.
6/24/21 started feeling very tired, achy, body was shaking like chills but no fever. Lost control of bladder function (never before) feeling like a UTI...hadn't had one since 1987. Kept getting worse, no energy, unable to even walk into hospital. went to Emer Room on June 27th.  Was admitted to hospital with Acute Renal Failure..due to "a kidney stone" that had blocked my kidneys which were no longer functioning.  All blood work numbers were off the charts as well as blood pressure which had never been  that high.. Never had kidney problems or kidney stone.  In fact, I had been disgustingly healthy up until that time... very rarely had to visit my pcp other than yearly blood work and mammogram.  PERMANENT DAMAGE REMAINS TO BE SEEN
1st shot: muscle pain in upper left arm and left shoulder for 3-4 days; This is a spontaneous report from a contactable other health care professional (patient). A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248) via an unspecified route of administration on 15Jan2021 at 17:00 in left arm as a single dose for covid-19 immunization. The patient had no medical history. Concomitant medication included escitalopram oxalate (LEXAPRO) 20 mg once per day taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks and had no known allergies. The patient was not diagnosed with covid prior vaccination and was not tested for covid post vaccination. On an unspecified date in 2021, after the first shot, the patient experienced muscle pain in upper left arm and left shoulder for 3 to 4 days. Patient was treated with painkillers and heat for the events. The outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Vaccine injection site got very sore, swollen and inflamed.  Onset of chills.  Next morning, 2/24, low grade fever 99.8.  2/25/2021 arm is still swollen, sore and red at injection site.   Temperature is normal.
Low grade fever, chills, Red, hot, swollen rash at injection site that is spreading to half of upper arm
Moderna arm. Hot red sore at injection site. Did not appear until 2 weeks after shot.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 03-APR-2014, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant (M.A) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L000571m expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Low grade fever that began the night of vaccine. Never past 100.4.  Pt taking acetaminophen for fever. Stomach ache, not diarrhea Nausea dizziness Radiating pain in both arms
Pt reports that 48 hours after injection her arm was red and swollen around the injection site. Pt reports that 3/4 of her arm was red and swollen. Pt took ibuprofen for pain and swelling. By 5 days post vaccine the symptoms were resolved.
Angioedema-my tongue swelled.  Was given saline, steriods, and a medication, and swelling went down in about 2 hours.