chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Last night I was shivering so bad that my teeth were even clattering; entire body aches; joints hurt so bad; muscles were twitching all over my body; chest got heawy; panic attack; armpits are swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Last night I was shivering so bad that my teeth were even clattering"; PAIN (non-serious), outcome "unknown", described as "entire body aches"; ARTHRALGIA (non-serious), outcome "unknown", described as "joints hurt so bad"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscles were twitching all over my body"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "chest got heawy"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attack"; SWELLING (non-serious), outcome "unknown", described as "armpits are swollen". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a 59 year old female with a "long pertinent medical history" and "multiple" drug allergies who on 21-DEC-2007 was vaccinated IM with the first dose of pneumococcal 23v polysaccharide vaccine. Concomitant medication included "quite a list" of medications. On approximately 22-DEC-2007, the patient experienced flu type symptoms and tiredness. The patient also mentioned that titers were drawn and did not elevate very much after 4 weeks from vaccination. The patient sought unspecified medical attention. Subsequently, the patient recovered from flu type symptoms and tiredness "after a couple of weeks." The patient currently has a staph infection. This is the 8th staph infection in the last 2 years. The patient also has "low IgG subclass." No further information is available. Additional information has been requested.
Pediatric patient presented to Covid vaccination clinic for scheduled second dose of Pfizer. Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine.  Patient had headache and feeling of pressure when breathing for five days after vaccination. Came to doctor's office on 6/24 for evaluation of symptoms and to be checked due to receiving Janssen vaccine. Still with headache and feeling of pressure with breathing. No chest pain. He has felt tired and like he doesn't want to do much. Exam normal. Oxygen sat 92%. Reassurance provided.
Information has been received from a registered nurse concerning a 17-year-old female with no pertinent medical history or allergies who on 27-APR-1998 was vaccinated subcutaneous with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) and her second dose on 17-SEP-2007. Concomitant therapies included amitriptyline hydrochloride (MSD), ethinyl estradiol/norgestimate (TRI-SPRINTEC) and another vaccine administered on 17-SEP-2007. On 20-SEP-2007 the patient experienced redness, pain, swelling and itching at the injection site of the left upper arm. The patient was examined in the office later the same day and the exam revealed 8x7 cm area of redness with a central 1.5x1.5 cm induration. The physician recommended cool compress and BENADRYL. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Follow-up information received on 07-DEC-2007 indicated the patient was vaccinated at 15:00 subcutaneous in the left arm on 17-SEP-2007 with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) (lot # 658406/1175U was previously reported as the first dose). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 17-SEP-2007 at 15:00 included a first intramuscular dose of BOOSTRIX (lot # AC528015AA), a first intramuscular dose of MSD vaccine (yeast) (lot # 658560/1062U) and a fifth intramuscular dose of FLUZONE vaccine inactivated (lot # U2436AA). On 19-SEP-2007 (previously reported as 20-SEP-2007) the patient experienced 8x7 cm area of redness with a 1.5x1.5 cm induration on the left post arm at the site of the varicella virus vaccine live (Oka/Merck) injection. The patient was seen in the office of the 20-SEP-2007 for red, swollen itch. On 01-OCT-2007 the patient was seen at a "visit" and was "okay". Additional information is not expected.
patient received Pfizer (age 5 to <12, orange cap) 7 days beyond it's expiration date. We are still waiting to hear back from Pfizer about whether dose needs to be repeated. patient's mother was informed of error
Contracted shingles in right ear, causing Ramsay Hunt Syndrome. Sustained approx 50% hearing loss in the right ear, constant ringing in the right ear, right side facial paralysis (mouth drupe, right eye stays open) severe vertigo.  Given medicine to kill the virus, prednisone steroids to heal damaged ear, two steroid shots to the eardrum.
Information has been received from a Registered Nurse (R.N.) concerning a 54 year old female "new hire" employee with allergies to latex and bee stings who had received a Hepatitis B vaccine series in 2006 (Manufacturer: Unknown. 1st dose on 07-MAR-2006, 2nd dose on 23-MAY-2006 and a 3rd dose on 01-AUG-2006). Titers were drawn as part of her pre-employment screenings and her titer was less than 5. So the patient opted for a second series of the vaccine. On 27-APR-2010 the patient was vaccinated IM in the left arm with a dose of RECOMBIVAX HB (lot# 665623/1024Y, exp: 19-JUN-2012). The nurse combined two pediatric (0.5ml) doses to equal one adult (1 ml) dose. Not long after leaving the employee health department the patient was across the street at the pharmacy and began to feel hot, starting spitting up mucous, and became short of breath. She went back to the hospital and was seen in the emergency room. The patient was in the emergency room for three hours. She was given epinephrine and possibly other medications (The nurse stated that she would know exactly what procedures or lab were performed when she got the ER records on 28-APR-2010). The patient recovered on 27-APR-2010. She was discharged home with prednisone and was not allowed to return to work until 28-APR-2010. The nurse requested a lot check. Upon internal review, feeling hot, spitting up mucous and short of breath treated with epinephrine were determined to be other important medical events. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation was performed. All in-process quality checks for lot number 665623/1024Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the research center and was released. Follow-up information has been received from an employee of a healthcare facility concerning the 54 year old female who also had an allergy to sulfa. There was no visible illness at the time of vaccination. On 27-APR-2010, the patient experienced shortness of breath (SOB), swelling, flushed and audible wheezing. The patient recovered on the same day. The reporter considered the shortness of breath (SOB), swelling, flushed and audible wheezing were to be life threatening illness. No further information is available. The patient was seen in the emergency room.
sweating; dizzy; not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 31Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (got a Covid shot, booster , Dose number unknown; manufacturer unknown), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious) with onset 31Oct2023, outcome "unknown", described as "not feeling well"; DIZZINESS (non-serious) with onset 03Nov2023, outcome "unknown", described as "dizzy"; HYPERHIDROSIS (non-serious) with onset 03Nov2023, outcome "unknown", described as "sweating".  Additional information: the patient reported that he always got a Covid shot, booster and everything and then he now got the new Covid shot that came out on Tuesday, Pfizer shot and he was not feeling well he had enough of this Covid shots, you felt a little down, sit on the couch a few days, didn't have your energy but, he got it on Tuesday today is Friday he was feeling worse than last Tuesday it's been 3 days he had enough of the Covid shot to know the routine, today I'm sweating, dizzy, this was not the reaction he got from the other Covid shots.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5], has been requested and will be submitted if and when received.
POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, was received by the partner on 03-AUG-2023 and forwarded to agency on 04-AUG-2023, from a Health Professional. Additional information was received by partner on 03-AUG-2023 and forwarded to agency on 07-AUG-2023.  Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis is not applicable.   This case is linked to other temperature excursion cases: MCM-005126, MCM-005127, MCM-005136, MCM-005135, MCM-005138, MCM-005140, MCM-005142, MCM-005128.  Further information is expected.
developed symptoms of intermittent chills, headache, jaw pain, and chest pain 2 days after receiving the shot. The next day went to an emergency room, was transferred to hospital. treated with one dose of IVIG and tylenol which led to resolution of symptoms.
Redness, heat, swelling, tenderness left deltoid and 2/3 way to elbow.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On 02-OCT-2014 the patient was vaccinated with improperly stored VARIVAX (Merck) (dose/frequency: 0.5 ml, route: subcutaneous). VARIVAX (Merck) was exposed to -7 Celsius for eight hours. No adverse effects were reported. No product quality complaint (PQC) was filed for VARIVAX (Merck). This case is linked to 1410USA009206 (same reporter link). Additional information has been requested.
6 mth old boy with history of perinatal HIV exposure, negative HIV test, with new-onset, afebrile, focal (left sided) seizure.  Required Ativan x2, then fosphenytoin IV, requiring intubation.  Patient admitted to pediatric intensive care unit.  07/09/2008 MR received for DOS 3/25-26/2008 with D/C DX: Afebrile, focal new onset seizure.  Perinatal HIV exposure.  Status Epilepticus.  Benign Hygroma, mild external Hydrocephalus. Infant transfered from local hospital intubated following new onset seizure in status epilepticus.  Parent noted unusual noises from crib and found infant with L sided jerking and eyes deviated down.  EMS called and attempted rectal Diastat without improvement.  In ER loaded with Ativan and fosphenytoin and intubated due to resp depression.  Extubated in current facility shortly after arrival.  Tx with abx/antivirals.  No further seizures.
Employee received a dose of Deptheria/Tetanus on 8/05/2002 and began having arm pain at injection site. Employee reported to medical on 08/08/2002 with marked cellulitis just distal to site. From 1 in below to elbow.
Severe stomach cramping, became very warm, and passed out.  Early had itching on the palms of both hands, hands swelled, difficulty breathing, rapid pulse.  Was driving at the time of reaction and passed out resulting in totalling vehicle.  Luckily I walked away basically unharmed except for the air bag impact to my chest and small neck bruise from the seat belt.  I am very lucky to be alive!
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that vials had not undergone any temperature excursion. Total of 102 doses/vials were given from LOT 026C21A.  Date the vial was initially stored in the refrigerator was reported as unknown.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information received included no significant information.
Raised little tiny bumps on both legs (thighs). Mom states that it was worse on her left thigh.
Headache, Arthralgia, ErythemaMultiform, Nausea Vomiting,  injection arm pain Narrative:
severe cramps; broke out into a sweat; very dizzy / she had never been so dizzy in her life; her eyes wouldn't focus; diarrhea; was so weak; passed out twice; seizure; fever/temperature up to a 100; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out twice) and SEIZURE (seizure) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 0D8ZZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Aug-2021, the patient experienced PYREXIA (fever/temperature up to a 100). On 01-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out twice) (seriousness criterion medically significant), SEIZURE (seizure) (seriousness criterion medically significant), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea) and ASTHENIA (was so weak). At the time of the report, LOSS OF CONSCIOUSNESS (passed out twice), SEIZURE (seizure), PAIN IN EXTREMITY (sore arm), MUSCLE SPASMS (severe cramps), HYPERHIDROSIS (broke out into a sweat), DIZZINESS (very dizzy / she had never been so dizzy in her life), VISION BLURRED (her eyes wouldn't focus), DIARRHOEA (diarrhea), ASTHENIA (was so weak) and PYREXIA (fever/temperature up to a 100) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 100 degree (High) up to 100 degrees.         No concomitant medications were reported No treatment medications were reported.  Company Comment: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of loss of consciousness and seizure. The events occurred 3 days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
ROTATEQ underwent a temperature excursion was administered to a patient; No adverse event; This spontaneous report has been received from a physician concerning a patient of unknown gender and age. The patient's drug reactions or allergies, concomitant therapies, medical history, and concurrent conditions were not provided.   On 16-MAY-2022, the patient was administered an Improper storage of product in use of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 2 milliliters (mL), orally (PO) (formulation, strength, vaccination scheme, and anatomical site of vaccination were not reported, lot number 1742420, which has been verified to be valid, expiration date reported and validated as 31-JAN-2023), as prophylaxis. The vaccine administered was stored at temperature of 53.2 degrees Fahrenheit (F) for a time frame of 3 hours. There was no previous temperature excursion. It was unknown if a data logger was used. No additional adverse event was provided.
This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 42-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the vaccination age of 42, via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included allergies, asthma and stomach function disorder; all from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. The patient had shortness of breath and diarrhea on unspecified date. Reported as, a 42 year old man who has a history of allergies and asthma along with stomach conditions, received the 1st dose of the Pfizer COVID-19 vaccine complaining of shortness of breath, and diarrhea. He wanted to know if these were side effects of the vaccine. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Mild soreness in left are at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: el3247), via an unspecified route of administration in left arm on 23Feb2021 at 14:15 (at the age of 64-year-old) as dose 1, single for COVID-19 immunisation at workplace clinic. Medical history and concomitant medications were not reported. The patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild soreness in left are at injection site on 23Feb2021 at 20:00 with outcome of recovering. The patient did not receive any treatment for the events. The outcome of the event was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2-4-21: 1 hour after injection my legs were weak and I had balance issues. 2 hours later 99.1 temperature. Extremely sore right arm. 2-5-21: Next day felt weak and had diarrhea. 2-6-21: Diarrhea and hives on stomach and upper thighs. Swollen eyes. Sore right arm.
+10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, twinge/cramp feeling in heart area +30 mins, sinus clearing and drainage (still continuing 5 hours later) +45 mins, itching under left side of tongue in thin line from base to tip, might be a nerve, arm getting sore +1 hr, gastro symptoms started, unusual feeling in intestines +2 hr, fatigue, tiredness +5 hr, chills +8 hr, dizziness +9 hr fatigue, tiredness +12 hr lower back pain and tenderness in kidney area, both sides +15 hr severe fatigue, tiredness, arm soreness/pain, other muscle pain +24 hr arm soreness, fatigue, tiredness +25-29 hr severe fatigue, tiredness, fever, couldn?t stay awake +54 hr severe fatigue, tiredness, fever, couldn?t stay awake Days 1-5: gastro system upset, nausea, diarrhea
tested positive post vaccination. COVID + Rapid: 2/16; COVID+ PCR: 2/18; Symptoms: Loss of taste/smell and cough; Source: Spouse(works at Medical Center) who tested COVID + on 2/8
Patient received Tdap vaccine in clinic on 7/19/16. Patient seen at hospital at 1550 on 7/20/16. She had c/o lower leg muscle weakness/leg pain and "constant Charlie horse" since the morning of 7/20/16. Hospital diagnosed her with paresthesia. Patient was offered admission and refused. Seen in clinic 7/26 with no c/o muscle weakness at this time.
Injection of SHINGRIX IM to patient's left deltoid on 2/21/18 and patient developed reaction 2/23/18 with symptoms of pain, redness, itching, warmth that migrated down from injection site. Only 2/26/2018, pt says that the warmth has gone away, and that the redness is getting better.
within 2 days of getting the vaccine I got a baseball sized rash on my left arm (site of vaccine) It appeared as having small bumps like a heat rash and was moderately itchy.  It lasted for 5 days.
Red, swollen ?ring? on skin around injection site that has become about the size of a quarter. Since the time that the adverse reaction was noticed the ring has been slowly getting larger in circumference. The ring is hot to the touch, slightly itchy, and painful. Ice was applied to the area  but there was no noticeable change after applying ice.
pt recv vax; devel rash on buttocks & genital groin area;enlarged "glands in neck";fever 100-101 x 6 days;walking a little stiff per mom;c/o HA & eyes red & swollen; dec appetite;skin now flaking from rash;
Pt recvd 3 doses of Hep B & devel lumbosacral plexopathy; No further details were provided;