chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a patient of an unknown age and an unknown gender. Information about pertinent medical history, drug reactions/allergies and concurrent conditions was not reported. On 24-OCT-2018, the patient was vaccinated with PROQUAD lot# R012272 with expiration date 28-OCT-2019, via subcutaneous (dose detail was not reported) for prophylaxis. The vaccine experienced improperly stored and was stored at 28 Fahrenheit degrees for less than 1 hour. There was no previous temperature excursion. The temperature excursion was detected by a data logger. The concomitant therapy sterile diluent (lot#M015992 with expiration date 26-NOV-2018) was not reported to be improperly stored by the reporter. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1901USA001175: US-009507513-1901USA001565:
Received vaccine about 10:00 AM and started itching all over her body around 1:00 PM.  She self treated with oral Benedryl.
Thursday morning (06/10/2021) patient noticed itching on hand, throughout the day the itching got worse. Boils started forming over hand. Caller went to ER on Friday morning. The ER gave antibiotic( doxycycline) and caller went home and the itching became worse so caller went back to the hospital and was prescribed merol dosack and hydroxyzine.  Caller was trying to deal with the issue but Sat the rash started spreading over bottom and as of Sun the rash spread all over. The rash is very itchy and very very irritating and is all over. Sun went back to ER and ran a battery of test and was prescribed veltrex.  On Monday morning (06/14/2021) the caller went to the dermatologist and was told that the rash appeared to be reaction to some kink of chemical to medicine the caller took.
faint; I had sore arm; I had sore arm with numbness; I had sore arm with numbness and tingling; Sore throat; running nose; Chills; Headache; Weakness; body aches/my body is in a lot of pain; joints pain; dizziness; nausea; This is a spontaneous report from a contactable other hcp for herself. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC31eZ, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on unspecified date of Aug2021 (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization. The patient's medical history included psoriasis from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Aug2021 at 15:00 immediate after vaccine patient had sore arm with numbness and tingling for 2 days, sore throat , running nose , chills , headache, weakness. After 24 hours patient start having body aches, joints pain with dizziness, faint, and nausea, weakness from that day to present. Patient did the vaccine 17 days ago and her body was in a lot of pain, joints pain, patient had days when she couldn't get out of bed. Patient had to call in to work multiple time because she couldn't function. Daily she had a lot joints pain all over her body. Treatment was referral to rheumatologist for treatment of psoria. Patient visit the clinic. Therapeutic measures were taken as a result of faint, i had sore arm, i had sore arm with numbness, i had sore arm with numbness and tingling, sore throat, running nose, chills, headache, weakness, body aches/my body is in a lot of pain , joints pain, dizziness and nausea. The outcome of the events i had sore arm and i had sore arm with numbness was recovered on 21Aug2021. Rest outcome of all event was not recovered.; Sender's Comments: Based on available information, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162B2
two pregnant women lost their baby and can no longer have children.; two pregnant women lost their baby and can no longer have children.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is the second of 2 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced miscarriage and she can no longer have children. The outcome of the events was unknown. The reporting consumer stated that "two pregnant women lost their baby and can no longer have children".  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101352584 Same reporter, drug and events, different patient
severe muscle wasting in upper arms & all the way down to hands w/very deep, pain in upper arm especially;arthritis was very mild a/shot;activated p/shot;BP 200/109;pain in upper arms;pain & msucle wasting was severe next day;
Intermittent diarrhea, consistent nausea without actually vomiting. Beginning on 5/14, still occurring  on 7/8
Blood sugars super high Rash on leg was burning now does not hurt Headache neck and body aches blurry vision Extremely tired
Fever of 105 /w brief seizure /win 12 hrs of vaccination. Wt 6.3 kg
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/08/21 2nd dose01/29/21 Diagnosed covid positive:08/12/21 Symptom onset:08/11/21 Exposure:community Symptoms:fever, cough, SOB,fatigue, loss of smell,nausea,vomiting,diarrhea,nasal congestion
Systemic: HEARING LOSS, BOTH EARS-Severe, Additional Details: PATIENT DEVELOPED HEARING LOSS WITHIN 2 HOURS OF ADMINISTRATION THAT HAS YET TO SUBSIDE. PATIENT HAS VISIT WITH AUDIOLOGIST LATER THIS WEEK TO ACCESS THE SITUATION.
Reaction from this and subsequent shots at facility:  flat affect, disassociation with body, trouble walking, "rubbery boned", feeling like I was shaking when I was not, surges of energy both horizontally and vertically in my arms and legs, cognitive dullness, mood swings, dry mouth, extreme lethargy.
oozing at site, it was like an open wound; bump at injection site larger than usual; bruising at injection site; pregnant patient vaccinated with Adacel; Initial information received on 16-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA260889 (same reporter).  This case involves a 20 years old female patient who experienced oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in pregnancy.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported events occurred at unknown gestation period. The date of last menstrual period was not reported but reported as 31 weeks ago. The estimated due date is 10-Nov-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2019, the patient received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5602AA, expiry date: 19-Mar-2021 via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of vaccine exposure during pregnancy.  Other relevant tests were not reported.  Final diagnosis was oozing at site, it was like an open wound (Vaccination site discharge), bump at injection site larger than usual (vaccination site mass) and bruising at injection site (vaccination site bruising).  Patient was advised to keep site clean and dry and take Benadryl. Keep eye on sute in case fever, growing in size and then go to ER if needed.  The outcome of the events was not reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  List of documents held by sender: none.
EDD: 01/18/2019 I developed an uncontrolled fever, hallucinations, body aches, joint pains, stiff neck, TMJ, due to this when I went to labor and delivery I was told I'm severely dehydrated and it is causing contractions. Iron and prenatals.
Injection site pain onset 5 pm on day of dosing. Fever, chills onset 11 pm with TMax of 101.9 at 1 am accompanied by decrease pulse ox to 90%.  Fever responded to Tylenol
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-NOV-2012, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries.  In May 2017, the patient was treated by a healthcare provider for shingles.  The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Left leg swollen with edema tracking to knee, Non painful and non erythematous, Pt no fever or malaise had 2 injection sites.
pt started having sz p/being put to bed @ 10PM on day of vax;EMTs were called pt was seizing & unresponsive;t104 pt was stabilized & released 2 days later;
As per mother, patient had a normal response to vaccine during first day. Yesterday child was refusing to walk, was limping favoring the right lower extemity. Today a rash and swelling of the thigh area was noticed. Patient states it hurts, but walks and runs. Mother was so concerned about an infectious cellulitis, that took child to ER.
I exp redness, swelling of the left arm(surrounding area of the injection) lasted from 1/9-1/11.
she had flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided a sfollows: The Age at vaccination was not reported. The reporter reported about her friend. The patient received Shingrix vaccine and experienced Influenza like symptoms. The reporter refused to provide any other details other than what was reported in this report. The reporter did not consented to follow up. This is one of 5 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097925:Same reporter US-GLAXOSMITHKLINE-US2021AMR099468:Same reporter US-GLAXOSMITHKLINE-US2021AMR099471:Same reporter US-GLAXOSMITHKLINE-US2021097926:Same reporter US-GLAXOSMITHKLINE-US2021AMR099470:Same reporter
sore right arm; warm to touch at the injection site; redness at the injection site; little swollen at the injection; hurting around the injection site; itchy right arm; A spontaneous report was received from a consumer concerning a 71-years-old, female patient who experienced itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 16 Jan 2021, approximately nine days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 037K20A] intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, the patient experienced her right arm itching and hurting around the injection site.  On 25 Jan 2021, the patient experienced redness, soreness, warm to the touch and swelling at the injection site  Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events itchy right arm, hurting around the injection site, redness at the injection site, sore right arm, warm to touch at the injection site and little swollen at the injection were unknown.
Weak, Fainting,  Dr kept me in hospital over night  To see my GP today
Swolen arm.  Dizziness, rash over body.  Facial rash
Mild to low fever of 100.2, runny nose scratchy throat, some fatigue.
PATIENT EXPERIENCED DIZZINES, LIGHTHEADEDNESS AND WEAKNESS ONE MINUTE AFTER ADMINISTRATION OF AFLURIA VACCINE. PATIENT DID NOT GET UNCONSCIOUS AND WAS TALKING AND ANSWERING ALL QUESTIONS.
Information has been received from a health worker referring to a number of unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with doses of improperly stored VARIVAX (dose, strength and route unknown, lot # L021215, expiry date: 10-JUN-2017 or lot #: L011085, expiry date: 01-APR-2017) or PROQUAD (dose, strength and route unknown, lot#: L023111, expiry date: 24-DEC-2016, lot # reported as L030589, expiry date: 10-FEB-2017, lot # K020750, expiry date: 30-APR-2016). There was no concomitant therapy reported. No adverse effects were reported. Additional information has been requested.
p/vax pt exp arm swelling from the shoulder to elbow;pt went to ER & was told was an allerg rxn;pt was also  told never to take the vaccine again;
Slightly tired; Pain where the needle went in for the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Acute pancreatitis (Idiopathic reoccurring acute pancreatitis). Concurrent medical conditions included Hashimoto's disease, Atherosclerosis, Gastroesophageal reflux disease, Hypoglycemia, Heart disorder, Vitamin D deficiency, Joint ache and Digestion impaired. Concomitant products included DOCUSATE SODIUM (COLACE) for Digestion impaired, OMEPRAZOLE for GERD, ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ 10) and FISH OIL (OMEGA 3 [FISH OIL]) for Heart disease, unspecified, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE AND CHONDROITIN) for Joint ache, ROSUVASTATIN for Sclerosis multiple, LEVOTHYROXINE SODIUM (UNITHROID) for Thyroid disorder NOS, VITAMIN D3 for Vitamin D deficiency.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection). At the time of the report, FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided for the first dose.
Shingles in L V1 distribution (Left forehead/scalp). Symptoms started 6 days after second vaccine dose.
She has a red, warm, swollen area approximately 4 x 3 cm on (L) upper arm.
Patient received Anthrax vaccine administration (Anthrax, series #4), via subcutaneous injection to right deltoid region (on 8 Mar 08 at approximately 10AM).  Patient did not receive any other vaccine at that time.  Later in the evening (approximately 7PM), patient noticed localized "swelling, redness, itching, tenderness (8/10), and pain (2/10) to my right arm where I was given the shot" (per patient).  Patient reported these signs on 9 Mar 08 to the clinic staff and doctor at the clinic.  Doctor recommended continued monitoring and patient use of over-the-counter Benadryl and Tylenol.
stroke; bipolar 1; Raynaud's disease; diabetes; flared up everything with his pre-existing condition.; having panic all night; This is a spontaneous report received from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on an unspecified date (lot number not reported), as dose 2, single, for COVID-19 immunisation. Relevant medical history included stroke, bipolar 1, Raynaud's disease, and diabetes all from unknown dates, not reported if ongoing or not. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY Solution for injection) received on an unspecified date (lot number not reported), as dose 1, single, for COVID-19 immunisation. On an unspecified date, the second dose of BNT162B2 flared up everything with his pre-existing condition (stroke, bipolar 1, Raynaud's disease, and diabetes). The patient stated that he's experiencing life-threatening reactions, having panic all night, all day from the vaccine because of his pre-existing conditions. The patient wanted to know how long the vaccine is designed to last in our body or is there a way to detox the vaccine out of his body since the vaccine is agitating with his pre-existing conditions. The outcome of the events was not resolved.  The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 16-FEB-2016, the patient was vaccinated with an improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of VAQTA lot# L023232 and expiration date: 25-FEB-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was very fussy then got very rigid and started grunting, sucking in air every 30-60 seconds - turned very red (almost purple), then passed out. Slept hard for 1.5 hour, paramedics came. Another doctor visit, he said she had a seizure.
nausea; vomiting; stomach cramps; explosive diarrhea; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201 expiration date: unknown), via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 50-years-old) at unknown, single dose for covid-19 immunization. Medical history included hypothyroidism and high blood pressure. The patient was not pregnant at the time of reporting. Concomitant medications included rosuvastatin, losartan, levothyroxine, liothyronine sodium (LIOTHYRONIN). Patient previously received TOPAMAX and experienced allergies and adverse side effect. The patient did not have COVID prior to vaccination. The patient did not receive other vaccine in four weeks. On 10Mar2021 at 02:45, the patient experienced nausea, vomiting, stomach cramps, and explosive diarrhea. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
skin rash with itching only; skin rash with itching only; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Feb2022 (Lot number: FL3209) at the age of 45 years as dose 3 (booster), single and intramuscular, administered in arm left, administration date 31Aug2021 (Lot number: FP8448) 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: 1st , Anatomical Site of Injection: Left Arm, Route of Administration: Intramuscular, Lot No: FA7485), administration date: 10Aug2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Small rash on chest, upper back and right arm opposite arm from vaccination site", "Dry cough", "Flu like symptoms", "no appetite", "Feeling very tired", "some stuffiness", "runny nose", "Headache", "feverish", "Generalized pruritus with skin rash/Constant rash with itching". The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset 01Sep2021, outcome "recovered" and all described as "skin rash with itching only". Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Vaccination Facility Type: Pharmacy or Drug Store, Vaccine Administered at Military Facility: No, treatment received for events with Hydrocortisone cream over the counter.  Follow-up attempts are completed. No further information is expected.
Primary Series Vaccine was given  inadvertently when Moderna Bivalent should have been administered.
Reaction to mosquito bites never experienced before (I am 86 yo).  A large area of skin around the bite swells and reddens.  A blister-like swelling that is filled with liquid develops  OR  a hard knot develops at entry point.  These last for days.  Itching  is intense.  Topical Corizone 1% doesn?t faze it.  A same-age female friend, who also received the Pfizer vaccine, is having the same atypical reaction.