chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 12-OCT-2012 18:08, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
States upon awakening 12/17/16 noticed a tender lump in (R) armpit size of half an orange. States (R) shoulder sore and has muscle aches. Tenderness and size of lump has not increased or decreased. Denies fever. Took ADVIL-provided some relief.
This spontaneous report was received from an office manager and refers to a 7-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517: US-009507513-1704USA004514:
The pt was brought to the office with her mother who stated she was called by the babysitter who stated the pt was developing a rash. The pt also had diarrhea for 1-2 days, eating, drinking well, no vomiting, no fever. The rash was covering her entire body and was maculopapular, also involving the palms, non pruritic. Treatment and monitor.
It has been almost 2 months and my left arm feels weird whenever I use my left arm. It feels like there is something stuck where I had the johnson shot. Its feels painful whenever I raise my arm. Its difficult to put on my shirt/top.
HIVES; CHILLS; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced vomiting. On 06-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, vomiting, and headache on 07-MAR-2021, and had not recovered from hives. This report was non-serious.
08/21/2001 MMR vaccine. Day 8 arthralgia, skin itching, knees, fist, hands intermittently. Swelling in arm, basically afebrile. Faint rash. Questionable spots.
I experienced fatigue that lasted for a few days; following my shot where I had short headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 30 years 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: FATIGUE (non-serious), outcome "unknown", described as "I experienced fatigue that lasted for a few days"; HEADACHE (non-serious), outcome "unknown", described as "following my shot where I had short headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt experienced itching skin on 2/2/01 and that evening started to break out in hives. States took 2 doses of Benadryl with some relief. States by 2/3/02 morning the whole body was covered with hives and went to the ER. Was given 2 steroid shots and sent home with 3 day supply of steroid medicine. Called on 2/6/01 and the pt states welts are still there, joints are sore, tired with some nausea. Advised to call family MD or go to ER. MD's office prescribed steroid medication. On 2/9/01 pt is better.
Patient was given second dose of Pfizer. First dose was Moderna. Patient reported no adverse effect. None was noted by staff. Lead nurse was notified . She was taken to the observation room and  cleared by onsite doctor after no adverse report was reported and noted.
Initial and follow-up information has been received from a consumer and medical assistant, for the Pregnancy Registry for GARDASIL. The consumer is a 22 year old female with a history of gallbladder removal about 10 years ago. On 08-Jan-2010, the patient received a dose of GARDASIL (lot # 663454/0672Y) IM. No concomitant vaccinations were administered at that time. The medical assistant stated that on 24-Feb-2010 the patient reported to the physician that she was pregnant. The patient was referred to the obstetrician. Her last menstrual period was on 23-Dec-2009. The consumer reported that she had a urine test when given the vaccine. The test showed she was not pregnant. A few weeks later, she found out she was pregnant. She went in for a blood work and an ultrasound on 06-Mar-2010 (also reported as 07-Mar-2010). They showed she would be 10 weeks pregnant but the fetus stopped growing at 5 weeks. As of 10-Mar-2010, the consumer was also experiencing spotting. The consumer stated that she had visited her physician's office on 11-Mar-2010 and the physician had confirmed that her baby was not properly developing. The consumer also reported that a dilatation and evacuation had been scheduled for her by the physician on 12-Mar-2010. The medical assistant reported that "the patient's sac was measured at six weeks and the patient had a miscarriage". On 12-Mar-2010, the patient was scheduled for a dilatation and evacuation procedure. Upon internal review, the fetus stopped growing at 5 weeks and miscarriage were considered other important medical events. Additional information has been requested.
Swelling and erythema of left thigh 7/5 cm x 7.5 cm lesion. Treated with ibuprofen, ice & BENADRYL.
Information received from an RN concerning a 6 year old female pt who on 6/23/95 was vaccinated with 1st dose of varicella virus vaccine live SC in the left arm. There was no post-vax rash. The child was exposed to varicella in school and on 12/22/99, broke out in full-blown chickenpox with multiple lesions and described as a "pretty nasty case." The pt was seen in the physician's office that day and noted to have varicella on her face, scalp, trunk and mouth. She was treated with Caladryl, Benadryl and Aveeno, and subsequently recovered.
Pt complained of SOB and chest pain at 1:10 pm approx. 2 hours after receiving H1N1 vaccine Pt did eat chicken from KFC prior to SOB and chest pain. Pt took BENADRYL, pt went to ER for treatment.   12/07/09 & 12/16/09:  ED Records for date of service 11/23/09.   Possible reaction to influenza vaccine.  Pregnant pt. presents with SOB, L pleuritic pain, fever.  Given nebulizer/steroid treatment without improvement.  Discharged in stable condition.  Advised not to take flu vaccine again.
02/04/2021  2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit  02/05/2021  2:00am  Set up to go restroom..  slight Forehead Headache.. upon standing Dizzy unstable. Weak..  Used walk and furniture for support.. after seated on the toilet head pain increased..  Felt Nausea (did not Vomit)..headache passed..  returned to bedroom. This took 35 minutes   02/05/2021  2:35am  seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021  3:00am  felt fatigued.. feel asleep 02/05/2021 9:00am  Awoke no issues..   02/05/2021  10:30am  Injection site left arm itchy..  no swelling .. no bruising.. tender to touch..  itchy sensation over full body
The pt was diagnosed with chicken pox on 2/12/01. Lesions noted on abdomen and chest, approximately 15 lesions.
Patient received vaccine 11/6/`5. On 11/7/15 pt. reports rash and some discomfort and (L) rib and back area. Pt. seen on 11/9/15 full shingles breakout. Not treated with antivirals. Infectious disease contacted. 11/13/15 follow up.
After receiving a Tdap vaccine and a PPD skin test client walked up to front desk to checkout. While standing at the front desk client fainted. BP, pulse, respirations were monitored for 1hour. Tourniquets administered above injection sites.
Angioedema; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angioedema.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Jan 2021, after vaccine administration, the patient experienced a severe allergic event. The event was angioedema which required multiple epinephrine injections.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, angioedema, was unknown.; Reporter's Comments: This case concerns a patient, who experienced event of angioedema. The event occurred the same day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Sick for couple of weeks from both the doses; Right arm hurts like deep into the bone; Pain making stomach feel upset; Right arm has hurt and moving up to shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for couple of weeks from both the doses), PAIN IN EXTREMITY (Right arm hurts like deep into the bone), ABDOMINAL PAIN (Pain making stomach feel upset) and ARTHRALGIA (Right arm has hurt and moving up to shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 017B21A) for COVID-19 vaccination.     No patient history was reported by reporter.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for couple of weeks from both the doses), PAIN IN EXTREMITY (Right arm hurts like deep into the bone), ABDOMINAL PAIN (Pain making stomach feel upset) and ARTHRALGIA (Right arm has hurt and moving up to shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Illness, Abdominal pain, Arthralgia and Pain in extremity, at an unspecified dose and frequency; MENTHOL (ASPERCREME HEAT PAIN RELIEVING) for Arthralgia, Pain in extremity, Illness and Abdominal pain, at an unspecified dose and frequency and LIDOCAINE for Pain in extremity, Arthralgia, Illness and Abdominal pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick for couple of weeks from both the doses), PAIN IN EXTREMITY (Right arm hurts like deep into the bone), ABDOMINAL PAIN (Pain making stomach feel upset) and ARTHRALGIA (Right arm has hurt and moving up to shoulder) outcome was unknown. Not Provided          Concomitant medications were not reported.  Reportedly, the patient used heating pad which made the pain more worse.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-AUG-2014 the patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # J003808, expiration date: 03-JUL-2014). The nurse reported that the patient received an expired dose of ZOSTAVAX on 13-AUG-2014. No adverse effect was reported. Additional information has been requested.
It was reported that patient had soreness after getting COVID booster shot.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (It was reported that patient had soreness after getting COVID booster shot.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (REMODULIN) injection for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 20-Nov-2020, the patient started TREPROSTINIL SODIUM (REMODULIN) (Intravenous) .07 microgram/kilogram. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN (It was reported that patient had soreness after getting COVID booster shot.). At the time of the report, PAIN (It was reported that patient had soreness after getting COVID booster shot.) outcome was unknown.            The concentration of co-suspect reported as 2.5 mg/ml The current dose 0.070 µg/kg  of co-suspect was reported as continuous, IV route. No treatment drugs were reported
On day 7 after shot at around 10am my upper left arm began itching . In the early afternoon a rash appeared. It  turned into a solid red patch of about 6 inches long by 5 inches wide which continued to itch. The upper arm also was also  sore.  It began to fade after two days and is almost gone at day 4.
My menstrual cycle has always been regular, this time around it came 8 days late; but now I've been spotting bright red blood for 5 days after my period; This is a spontaneous report from a contactable Nurse (patient). The 42-years-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2, lot number: EH9899), intramuscular on left arm on 20Dec2020 19:45 at single dose for covid-19 immunisation. Medical history was none. The patient did not receive other vaccine in four weeks. No Covid prior vaccination, No Covid tested post vaccination, No Known allergies. The patient's concomitant medications were not reported. It was reported "My menstrual cycle has always been regular, this time around it came 8 days late, which didn't concern me, but now I've been spotting bright red blood for 5 days after my period, which NEVER happens. My tubes are tied so I shouldn't be pregnant." The event was onset on 07Jan2021. No treatment received. The patient did not recover from the event.  No follow-up attempts possible. No further information expected.
she developed a limp wrist, no dexterity and can not use her wrist.; she developed a limp wrist, no dexterity and can not use her wrist.; She developed a limp wrist, no dexterity and can not use her wrist.; Has a little bit of use of the fingers in the soft closed U formation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ARTHROPATHY (non-serious), FINE MOTOR SKILL DYSFUNCTION (non-serious) all with onset 02May2021, outcome "recovering" and all described as "she developed a limp wrist, no dexterity and can not use her wrist."; MOBILITY DECREASED (non-serious) with onset 02May2021, outcome "recovering", described as "She developed a limp wrist, no dexterity and can not use her wrist."; FINGER DEFORMITY (non-serious) with onset 02May2021, outcome "unknown", described as "Has a little bit of use of the fingers in the soft closed U formation".  Additional information: Reporter stated that on 02May2021, patient developed a limp wrist, no dexterity and cannot move her wrist. Patient has a little bit of use of the fingers in the soft closed U formation. There was minimal improvement since this began. The patient was afraid to get her second shot on 21May2021. The patient was seen by her primary care provider and the doctor didn't have any idea about what was going on. The patient will be seeing a neurologist and neuro specialist on 14May2021. The patient takes a medication for hypertension and a blood thinner but does not know the details of these medications or any other daily medications that the patient takes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child was given a double dose of Varicella vaccine.  Once when he was 15 months old, then again when he was 5 years old (7/13/09).  On his left leg, he had MMR and Varicella vaccine.  This leg has been swollen from top of the thigh to mid-knee, and a red rash has occurred. The child has been given Benadryl, Tylenol, warm compresses, and elevated, but reactions have not sub-sided after 48 hours.
Within 1 hour of flu vaccination, patient developed redness 3 inches distal to the injection site. The site was itching, no hives or swelling were present. She had a medical appointment scheduled for her doctor later that afternoon. Her MD stated that he was not concerned her response to the vaccine and to take BENADRYL for any itching. She was having some itching on her back and shoulders. She was instructed to follow up with doctor if symptoms did not resolve.
Fever began at about 5pm at 99.5. Chills, fatigue, aches, headache. At approximately 9pm fever read 101.8 on in the ear home thermometer. Took 2 Motrin. Woke up at 6am without fever. But still had general unwell feeling.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 12-FEB-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-FEB-2016, the patient was treated at a healthcare facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient is here today for a bump on his left shoulder. He noticed it a few days after his first Covid vaccine (08/09/2021). It was a big bump but has decreased in size, was painful when moving his arm. Denies fevers and he does not have a fever in office.   First vaccine received at beginning of month, due this week for # 2. Few days after tired and sore arm, otherwise well.
received expired dose of Pediarix; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 23-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd September 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd September 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported pediatric patient received expired dose of Pediarix, which led to expired vaccine used. The reporter consented to follow up.
Pt mother called and reported softball size rash to (L) leg and red rash to neck and pt is slurring her words. Stated she just noted these s/s today. Was told to take child to ER.
Approx 18 hours after injection: fatigue, muscle aches, chills, and fever lasting approx 24 hours. Max fever 102.5° approx 24 hours after injection.   Approx 36 hours after injection: small red rash (approx 2 inches diameter)  formed about 3 inches below injection site. Muscle tightness/soreness underneath rash area. Rash continues and (more than 72 hours after injection) has grown to approx 5 inches in diameter and still remains approx 3 inches below injection site. No itching, only slight pain when pressed. Rash is noticeably warmer than surrounding skin.
Patient fainted out of the chair he was waiting in after receiving his COVID shot 10 minutes prior. A shopper alerted our staff and when I came to check on him, he was just rousing but had his eyes closed due to blurred vision. He was able to speak and look directly at me. He said this reaction had never happened to him before. He seemed jittery probably due to the reaction. Asked for water and was able to drink. He said that he most likely hit his head and compressed his finger during the fall but feels okay. We are not sure how long he was out for.