chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose.; had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200149332 (Pfizer).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), NAUSEA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "had experienced day-long nausea/vomitting after receiving the vaccine, I believe after the first dose."; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhoea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax; devel marked swelling, tenderness & erythema at inject site; HA & fever; seen by MD on 15aug94; tx w/ ibuprofen; fever & HA resolved & inject site rxn improved;
Very sore shoulder next day Woke up terrible headache, chills , runny nose and coughing almost constantly. Practically bed ridden for 2 days.I was non-functional then. Still have the cough. I know this sounds silly, but it's almost like I  the virus.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 13-JUN-2017, the patient was vaccinated with an expired dose of M-M-R-II injection (dose and route of administration were not reported) lot number L019989 and expiration date 01-JUN-2017, for prophylaxis. No adverse effects were reported. Additional information has been requested.
Weakness and tingling of arms and feet, that started around 4:00 A.M. and spread to the lower back. 4:45 A.M. inability to walk, elevated heart rate of 102 resting, and 103.1 degree fever. Pins and needles in  fingertips currently actively present, extreme pain in injection site location, currently actively present.
Diarrhea; Has a temp of 100; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced diarrhea and he had a temp of 100. The caller stated, her husband had his Pfizer first vaccine on Tuesday and this morning he woke up with pretty extreme diarrhea and she just checked him he had a temp of 100 so. The caller also stated, she just needs to know about her husband's symptoms and who needs to know those and what she should do about it. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
OUT OF SPECIFICATION PRODUCT USAGE; INCORRECT PRODUCT STORAGE; 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: 043A21A, expiry: 19/SEP/2021) dose was not reported, administered on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-AUG-2021, the patient experienced out of specification product usage. On 31-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product usage and incorrect product storage was not reported. This report was non-serious.
This spontaneous report as received from a nurse refers to a 47 year old female patient. The reporter read a frequently asked questions (FAQ) from a facility in which the patient on an unknown date, was inadvertently vaccinated with a dose of ZOSTAVAX (unknown strength, dose) instead of VARIVAX. Concomitant medications were not reported. It was unknown if any adverse effects occurred. There was no product quality complaint involved. Additional information has been requested.
the site is a little sore and tender; She may have had a slight fever of 98.6; This is a spontaneous report from a contactable consumer or other non-healthcare professional. An 80-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2, intramuscular, administered in right arm on 04Feb2021 at 14:03 (Batch/Lot Number: EL9264, Expiry date was not reported) as single dose covid-19 immunisation. Medical history included ongoing thyroid and underwent knee replacement in Jul2020 and sometimes have trouble with it. The patient has family cancer history. Concomitant medications included rivaroxaban (XARELTO) (20 mg daily by mouth) taken as blood thinner from an unspecified start date and ongoing; levothyroxine (50 mcg, take once daily by mouth) taken for thyroid ongoing from an unspecified start date; prednisone (Blister pack take six, then five, and down to one daily by mouth for six days) taken for intervertebral disc degeneration from 21Jan2021 to 26Jan2021 (She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain). The patient did not receive any vaccinations within 4 weeks prior to covid-19 vaccine administration. The patient did not have any illness at the time of vaccination. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in right arm on 15Jan2021 at 09:57 (Batch/Lot Number: EL2346, Expiry date was not reported) as single dose covid-19 immunisation. On 04Feb2021, the patient experienced little sore and tender. On an unspecified date in Feb2021, the patient had slight fever of 98.6. Clinical course was reported as she received the second dose of the Pfizer COVID 19 vaccine 04Feb2021 1403PM in the right arm. Today the site is a little sore and tender. She may have had a slight fever of 98.6. The first time she felt great after the shot and was bragging to her friends about it. Add she thought the shot clinic was really well organized but when she went in to get the shot there was a guy sorting through the box and she wondered why. The events did not require any visit to physician office or emergency room visit. Outcome of the events little sore and tender was not recovered and slight slight fever of 98.6 was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report has been received from a medical assistant and an administrator and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M036056, expiration date 18-MAY-2019; dose, route of administration, and frequency were not reported), for prophylaxis. The vaccine data logger measured a temperature range from 32°F to 35°F (0°C to 1°C) for a total time frame of 1 hour (1 cycle) on 24-JAN-2017, 3 hours (3 cycles) on 25-JAN-2017 and 4 hours (4 cycles) on 26-JAN-2017 for a total of 8 hours (8 cycles). The medical assistant mentioned that the vaccine was exposed only for 1 hour and 30 minutes at a temperature as low as 33.1°F, the other cumulative hours were at 34°F.. There was no previous temperature excursion. No adverse effects were reported, and a product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001785: US-009507513-1704USA001786: US-009507513-1703USA008107:
Patient had a syncopal episode following his immunizations. Complaining of not being able to see well and feeling dizzy before he passed out. He came to very quickly but was very pale. Patient felt "kind of shaky" before end and after passing out. Observed pt 30 min after and was doing well.
Localized reaction to both arms. Rt deltoid baseball size red area. Lt deltoid dime size area that had streaks down the arm. Urticaria large, tense area on rt delt and smaller one on lt deltoid. No angitis or cellulitis.
Pt exp a sudden onset of h/a, vomiting, & chills 3 hrs p/receiving Typhoid vax; Pt recovered p/24 hrs;
Approximately 13 minutes after vaccine, 10:49 a.m., patient stated she felt like she had a lump in her throat.  No other symptoms, lungs clear, respirations normal, BP 190/80 initially but recheck 124/72.  Dr. came to examine patient and ordered Epinephrine with some improvement in symptoms. Patient taken to ED by wheelchair.
Immunization was given 09/14/2001. PPD negative on 09/17/2001. On 09/18/2001 pt presented with cough, congestion. Dx: URI. Tx: Carbinosane Syrup and Tylenol PRN fever. On 10/02/2001 pt presented  with lump left site of neck since 10/01/2001. Complained also of itching. Mom noticed lesion on back of left ear and one near buttocks. Within a few hours broke out in rash over neck, face, trunk and extremities. complained of runny nose. No fever. Diagnosis of varicella infection. Advised Benadryl and Aveeno baths.
After receiving the Moderna booster shot I began to get red, hot, itchy hives all over my body including my arms, legs, face, neck, stomach, back, palms of my hands and soles of my feet. It became hard to walk and do anything with my hands without experiencing itchy pain. The hives continue to happen whenever any pressure is applied to my skin.
6 months after vaccine blood clots went from my legs to my lungs and I went into cardiac arrest
PT. DEVELOPED SWELLING, REDNES AND PAIN  AT BOTH RIGHT AND LEFT THIGH RADIATING TO GLUTEAL AREA.
Pt had episode in afternoon after receiving DTaP. Awoke from nap "tired and fussy." Lips appeared to turn "purple" to mom and pt appeared very pale in face. No loss of consciousness. No tonic clinic activity. No fever. Lasted approx. 5 minutes then pt fell asleep. Awoke at MD office approx. 20 mins later happy, playful, and smiling. No treatment, no addition, symptoms.
Patient was given a vaccine without a written consent, without knowledge of her medical conditions or allergies.  She had already received 2 Covid vaccines and the vaccinator gave her a 3rd dose.
Severe headache; Sinus Pressure; Body aches; fever symptoms; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 30-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm as dose 2, single on 10Feb2021 14:00 (at the age of 30-year-old) for covid-19 immunisation at workplace clinic. The patient's medical history was not reported and no known allergies. Concomitant medication included ibuprofen(Advil) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EL3247), via an unspecified route of administration, administered in right arm as dose 1, single on 20Jan2021 13:00 (at the age of 30-year-old) for covid-19 immunisation. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medication within 2 weeks of vaccination: ibuprofen. On 11Feb2021 10:00, patient experienced severe headache, sinus pressure, body aches and fever. No therapeutic measures were taken as a result of the events. At the time of this report, outcome of the events was recovered on unspecified date in Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
I had similar reaction 3 times after receiving the 2nd dose of Pfeizer vaccine.  Sequence - chills, uncontrollable shivers, severe body aches, fever of 101-102, sweats and then was gone. These reactions lasted approx 12 hours each time.  My 2nd dose was April 27, my reactions occurred on April 28 at approx noon until the next morning, then again on May 9th and the 3rd occurrence was on May 28th. I did get a covid test (nasal swab) on May 10th - confirmed negative for covid.
Patient called to let us know about a small bruise surrounded by a red, warm, circular area (about 3 inches) at the site.
Patient experienced vasovagal reaction post vaccine. Hit his head on the floor. Transferred to hospital for evaluation.
Case previously recorded as MA2009-3234. Initial case report received from a health care professional via MedCom on 23 OCT 2009. An unknown number of pregnant women were vaccinated with 0.5 mL S-OIV FLUVIRIN (batch no. 1008132) i.m. on an unknown date. Vaccine was stored between temperature of 17 and 43 F for 24 hours and frozen at some point. No adverse event was reported. MedCom reference no.: NA09-006957.
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00531838) and transmitted to Sanofi on 23-Mar-2021.  This case involves a five-year-old male patient who received an expired 0.5 mL 4th dose of IPV (VERO) [IPOL] (lot R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in the thigh for prophylactic vaccination on 18-Mar-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for prophylactic vaccination.  This was a case of actual medication error due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Zostavax injection burned and it itched immediately. Six hours later site of injection was red. By Thur night (the next day) patient had severe muscle and joint pain and injection site hot. Friday - it was redder and had spread to elbow. Patient had fever, soreness, itching. Sat AM patient went to Dr. Red all the way to elbow with a dark red circle.
patient received an expired dose of MMR II; no additional AE reported; This spontaneous report was received from a medical assistant and refers to patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-MAR-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot number T007233 with expiration date 27-FEB-2022 (expired product administered), (dose, route, anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
Fatigue; Chills; Headache; Nausea; Vertigo; Sore throat; This is a spontaneous report from a non-contactable other Health Care Professional (HCP).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown), intramuscularly, on 04Jan2021 at 10:00 AM (at the age of 36 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. No allergy information was reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Jn2021, the patient experienced fatigue, chills, headache, nausea, vertigo and sore throat. The events resulted in a physician office visit. Treatment information was not provided. The patient underwent lab tests and procedures which included sars-cov-2 test on an unspecified date after the vaccination the result of which was negative. The clinical outcomes of fatigue, chills, headache, nausea vertigo and sore were reported as recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient had received 1st dose of the vaccine on the left arm. Ensured no allergies prior to vaccinations. No known issues prior to vaccination. After vaccine, patient was not complaining, alert, and stood up immediately. Waited around with friend for a couple minutes before fainting in front of patients/ staff. She fell forward and hit her chin. Her chin has a cut and was bleeding through her mask.  We called EMS requested help from the paramedics. They came to tend to her and she refused to be taken into the hospital, but will go via her own transportation to get her cut stitched up.
aches, pain, chills, t99 day of vax; taste in mouth different; sent to ER; body hot-face burning lasting 2 hrs everyday;
tested positive; tested positive; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: EW0164) at the age of 47 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; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23May2022 at 15:00 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jul2022 at 09:00, outcome "not recovered" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (04Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (05Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (06Jul2022) positive, notes: tested positive and continue to test; positive (4 days now); (07Jul2022) positive, notes: tested positive and continue to test positive (4 days now). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid as COVID 19 Treatment from 26Jun2022 to 30Jun2022. 4 days after completing Paxlovid patient tested positive and continue to test positive (4 days now) without fever. Patient stated that she did feel like might have a sinus infection.  No Follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 16-FEB-2016, the patient was vaccinated with a dose of VAQTA (lot # L002717 and expiration date June 2017, unknown route), which was exposed to temperatures outside of the recommended range. There were no concomitant medications provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Five hours after immunizations, patient called & states arm red & swollen in arm where pneumonia shot (left arm) administered. Suggested to take some BENADRYL and seek medical help. Follow-up call on 12/26/10, patient states arm is better, swelling and redness relieved.
Patient had COVID vaccine on 2/1/2021. States skin over injection site on left shoulder had started to become red, warm, and itchy on 2/5/2021. Area of redness has progressed to the size of her hand by the time of clinic visit 2 weeks post vaccination; not severely painful. Has been using Benadryl which has helped with the itching but is transient in overall relief.
Client received the Janssen COVID vaccine (lot # 1808980 and expiration date 6/20/21) at 3:25PM.  At 3:28PM EMT took vitals:Pulse: 82, blood pressure: 116/80, and oxygen: 94% due to client saying she felt a little shaky.  Client report that she is allergic to iron infusions and takes hypothyroidism medication and has a history of anxiety.  At 3:34PM vitals were Pulse: 85, blood pressure: 120/80, and oxygen: 95%.  At 3:40PM PHN was notified and found patient sitting in chair alert and oriented x 4.   Client also reports to PHN that she has a history of tachycardia and prior to notifying EMT she had a slight headache develop and a short dizzy spell that resolved.  At 3:43PM vitals were oxygen:  97%, blood pressure: 120/78 and pulse:75.  Client reports "feeling better and not shaky anymore." and "headache feels better." At 3:50PM client vitals were: blood pressure 116/80, oxygen: 97% and pulse: 76. Client alert and oriented X4 and reports no symptoms at this time and holding a conversation with no problems. At 3:58 PM vitals were oxygen: 97%, blood pressure: 110/80 and pulse:77. Provided client with emergency precautions. Client left facility with a steady gait at 4:03PM.
PATIENT GOT MILD PAIN,FEVER,SEVERE REDNESS,ITCHING,HEAVINESS AND AFTER A WEEK DOCTOR SAID ARM GOT INFECTED AND PATIENT IS ON ANTIBIOTIC
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received FLUARIX QUADRIVALENT. On 18th November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 18th November 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain (serious criteria disability), bursitis (serious criteria disability), wrong injection technique and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and bursitis were recovering/resolving and the outcome of the wrong injection technique and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site pain and bursitis to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received an unknown concomitant medication. The patient received FLUARIX QUADRIVALENT on an unknown arm. The patient complained about pain and bursitis in her arm after receiving FLUARIX. The patient thought that the injection was too high in her arm, and it was administered in her tendon instead of the muscle which led to wrong injection technique and vaccine administered at inappropriate site.