chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer refers to her daughter, an approximately 5 year old female patient (currently 22 year old) with no pertinent history and no drug reactions/allergies. In 1996, the patient was vaccinated with a dose of live (Merck) VARIVAX (dose, route and lot # not reported). There were no concomitant medications. Since approximately 1996 when she was a child (the third week after the vaccination), the patient had been experienced blood in stool every time she went to the restroom. Her recent test of antibody IgG to varicella was 1129 (normally 0-165). The patient saw many doctors and had many tests but could not determine the cause of the blood in stool. The patient was treated with prednisone, FLAGYL, PENTASA and ROWASA for the event. The outcome of blood in stool was reported as not recovered. The relatedness for blood in stool was unknown for live (Merck) VARIVAX. Additional information has been requested.
One day after flu vaccination, 10/10/18, she came to Employee Health to reveal a bright red circular area directly below the site of her flu vaccination, and it measured approx. 40 mm.  She states it does not hurt, nor itch, denies warmth.  It is not raised.  No c/o other s/s.
Red rash, Flat noted at IPV IM site right arm and red rash flat noted 4cm at MMR site SQ right arm TX with 10mg Zyrtec PO x 1 dose per MD. Rash noted approximately 5 minutes post injection. Zyrtec given immediately upon discovery.
Sore Neck; Achy muscles; Fever; Chills; Sweats; Swollen, sore joints; Swollen, sore joints; Has a bad back; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Sep2021 19:00 (Lot number: FA7484) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Feb2021 (unspecified if ongoing), notes: Verbatim: COVID-19. The patient's concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 16Sep2021, outcome "recovering", described as "Sore Neck"; MYALGIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Achy muscles"; PYREXIA (non-serious) with onset 16Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 16Sep2021, outcome "unknown", described as "Sweats"; JOINT SWELLING (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2021, outcome "recovering" and all described as "Swollen, sore joints"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Has a bad back".  Additional Information: Caller states that all of his symptoms began on 16Sep2021. Says the aches and soreness are still bad, but getting better.  No follow-up attempts are possible. No further information is expected.
p/vax pt had sl deltoid ache; sl weakness in lt arm;inability to lift or abduct arm from body;dx brachial neuropathy d/t toxic &/or hypersensitivity;
Patient states stomach upset and chills started 10/4/19.  Progressed to redness of left arm below injection site and soreness of arm on 10/5/19.  States she developed diarrhea on 10/7/19.  Symptoms first reported to pharmacy on 10/7/19.
Injected arm-Upper arm pain at injection site; Extremely swollen arm pit; Pain down arm; Swollen hand; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injected arm-Upper arm pain at injection site"; SWELLING (non-serious), outcome "unknown", described as "Extremely swollen arm pit"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain down arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen hand". Additional information: the patient received COVID-19 Bivalent Vaccine, experienced injected arm-Upper arm pain at injection site, extremely swollen arm pit, pain down arm, swollen hand. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt came in approx 19 hours after vaccine was given with drooping of right side of face that was progressively getting worse which is typical in a Bell's palsy reaction. Sent pt to MD who referred to ER. ER gave pt prednisone and antiviral.
The patient's mother states, on 01/31/01 this baby was very irritable, not sleeping, and a rash appeared on 02/01/01. She called the health dept and told to take her to the doctor. The mother states the baby had a seizure on 02/07/01 and was hospitalized for one day. The baby okay, but the same states the mother. The baby's right side weak states mother. The mother is to call the child's MD to inform of the child's condition.
A male patient comes to be vaccinated with his first dose of PFIZER and at the end of his 15 minutes the patient reports that he is dizzy and goes to the observation area where the EMT to take vital signs at 2:24pm 74P, B/P 120/80, Dxt 98, clear lungs and normal skin observed. 2:24 pm Dr. recommends that he take 3 acetaminophen 500mg at 2:27pm and recommends leaving it for observation at 2:55pm Re-evaluation P70, SAT 95, B/P 120/80 Resp 15, 3:05 recommends leaving. Patient says they feel much better.
Right arm numbness and tingling, joint pain right  wrist and hand  x 12 hours. Bilateral hip and knee pain-ongoing. Burning nerve pain in shoulder, neck and right side of face .x12 hours.  Ongoing low grade fever 99.5-100 and fatigue.
Severely painful and bloody sores inside mouth, gums, and tongue, and roof of mouth.
pt recv vax;devel gen itchy urticarial rash on both arms,thighs,neck & upper chest;to MD;at time of report rash persisted;
Case number PHEH2016US029330, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 38 years old male patient. Past medical history and concomitant medications were not reported. The nurse stated that, first temperature excursion of FLUCELVAX QUADRIVALENT at 52 Fahrenheit for 01 hour occurred on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34 Fahrenheit and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 01 Nov 2016. Third temperature excursion occurred on 02 Nov 2016, down to 32.2 Fahrenheit three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this medication error.
Immediate pain in (L) arm at time of injection persistent. Chronic pain at site of injection continuously since that time. Found to have tear of tendon at evaluation in May. No interim injury or event to explain pain. VASRI
Red Blotch in the injection site about the size of a fifty cent piece, swollen and mostly itchy.
She was supposed to receive her 2nd dose on 05Mar2021 but became really ill and was not able to get to her appointment; ill; "The initial case was missing the following minimum criteria: like (unspecified adverse event under BNT162B2). Upon receipt of follow-up information on PRD 02Apr2021, this case now contains all required information to be considered valid."  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021365361 (PFIZER).  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 (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: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "She was supposed to receive her 2nd dose on 05Mar2021 but became really ill and was not able to get to her appointment"; ILLNESS (non-serious), outcome "recovered", described as "ill".  Follow up (02Apr2021 and 13May2021): The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (02Apr2021), this case now contains all required information to be considered valid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at injection site that lasted for a couple days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included epilepsy (experienced all her life) and seizure (experienced all her life).   On 31st August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The report was a patient's husband. The patient received vaccine in left arm. The patient experienced soreness at injection site that lasted for a couple days. No further details were provided. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2019201978.
"w/in 1hr of vax redness & induration occurred-redness & induration measuring 6x8cm noted 48hr;later warm to touch, pt reported aching @ site;recommended use of DPh & Ibuprofen;"
pt recv vax;fever,chills,dizziness,lethargy,upper resp congestion for 2 days p/ vax;migraine HA for 4 days;denies v,d,dyspnea,dysphagia or rash
8 days post first dose of Moderna COVID-19 vaccine, developed a painful, itchy rash on right arm around the injection site. Rash covers entire shoulder.
Pediarix and Ipol given on same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9552X, expiry date 26-OCT-2024) for prophylaxis.   Co-suspect products included POLIO VACCINE (IPOL) for prophylaxis.   On 13-APR-2023, the patient received Pediarix and IPOL. On 13-APR-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Pediarix and Ipol given on same day). The outcome of the overdose 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 Information: GSK Receipt Date: 18-APR-2023 The reporter was a clinic manager. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal. The patient received Pediarix and Ipol Polio vaccine on the same day, which led to overdose.
Client received a 2nd dose of COVID vaccine at our clinic today. Client was supposed to receive a 2nd dose of Pfizer (as he had gotten a 1st dose of Pfizer not at our site), but he was errantly given a dose of Moderna. Client was informed, educated and facility incident report completed.
PATIENT HAD PFIZER COVID-19 VACCINE  Dose 1 date: 12/22/2020 ,Dose 2 date: 01/13/2021, AND TESTED POSITIVE TO COVID.
2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose. P
Pt recvd 3 doses of Recombivax in 1989 & booster w/Engerix-B; pt did not respond to either;
After exposure to the sun, I developed a bright red rash that was bumpy and itchy. I went to my dermatologist. I was prescribed Prednisone and a steroid cream.   The rash is mostly gone.
pulmonary embolism, acute heart failure with reduced ejection fraction, transaminitis, and pericarditis
Pt called 10/21/2022 to discuss adverse effect that start on 10/19/2022 after receiving moderna bivalent booster. Pt states arm is red, swollen and warm to the touch. Pharmacist counseled that local injection site reaction is reported as a possible side effect for the vaccine. Pt should monitor the site for any additional changes in size, color or temperature and to follow up with their PCP for additional evaluation if needed. Pt was informed VAERS report would be filed for the reaction.
Day after vaccination client called and stated Lt lat upper arm red and swollen about 3 inch in diameter with raised bumps on surface. Client has no temp or other symptoms. Advised to check with private provider. MD said to take ibuprofen but did not need to be seen. Saw client on 4 days after vaccination, area still red, slightly raised but improving. No further problems (area was varicella vaccination).
Patient reported shortness of breath, fatigue, and upper arm weakness. Her physician called on 2/25/10 and reported that within 8 days of receiving the shot she (the patient) reported her symptoms.
pt recv vax 20FEB96 & voice higher pitched for 2 days but not jittery, febrile or irritable
I had fever of 102.  I had body ache, chills, and a mild cough.  I also have fatigue.  These lasted for about 4 days.  On Dec 28th, I tested positive for Covid-19.
Pt came in requesting third vaccine due to being obese and also wanting to be protected for new job 3rd dose given too soon after primary dose
About 10 min after injection, experience dizziness, lightheadedness, also described numbness to face and drawing of hands.  stated she could move her hands, developed some tachypnea and mild SOB with hyperventilation.
Fever; Flu like symptoms; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 17-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 06Jun2021 at 12:30 (at the age of 17-years) as dose 2, single for COVID-19 immunization. The patient medical history included were not reported. The patient's concomitant medications included ibuprofen (IBUPROFEN). The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration in the right arm on 14May2021 at 15:45 (at the age of 16-years) as a dose 1, single for COVID-19 immunization. The patient had no known allergies. The patient had not received any other vaccines within four weeks prior to the vaccination. On 06Jun2021 at 17:30, the patient experienced joint pain; and on 06Jun2021 at 19:30 fever, flu like symptoms. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events was recovering at the time of report.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Information has been received from a 55 year old female patient with diabetes mellitus who on 23-AUG-2010, reported as 4 weeks ago, was vaccinated with a dose of ZOSTAVAX (Merck) (route, site and lot number not reported). Concomitant therapy included vitamins (unspecified), betaine and herbs (unspecified). On 30-AUG-2009, reported as 3 weeks ago, the patient experienced loss of sense to taste. She also reported that she was having episodes of uncontrolled diabetes. There were no other adverse effects reported. The patient did not seek any medical attention. Additional information has been requested.
pt recvd vax;1 month p/ dose 3,was found to have erythema nodosum on anterior thighs;seen by MD who prescribed corticosteroids;
Developed redness and swelling of thigh at site of flu shot administration, progressively worsening over the next 24 hours. No fevers. Walking with limp, but able to bear weight.  No V/D, no URI sx.  Recommended ice, NSAIDs, started Augmentin in case of infectious component, though I suspect inflammatory reaction to vaccination.
Severe dry heaved from 11:45pm on 5/7/21 the night of the vaccination, until 5pm Saturday.  At the peak, every 15min I'd heave bile.  Terrible headache and heaving bile.  Laid in bed or heaved in a bucket.
had a drug interaction with pfizer covid-19; told that the drug interaction pfizer covid-19 affected her right hip.; she had debility with ambulation for 5 days; brain fog; pain; She was only capable of ambulating from bed to bathroom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2020US100435_NS.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), administration date: 23Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "she had debility with ambulation"; Bnt162b2 (first dose), administration date: 23Mar2021, for Covid-19 immunization, reaction(s): "pain", "brain fog". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "she had debility with ambulation for 5 days"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "brain fog"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain"; DYSKINESIA (non-serious) with onset 2021, outcome "unknown", described as "She was only capable of ambulating from bed to bathroom"; DRUG INTERACTION (non-serious), outcome "unknown", described as "had a drug interaction with pfizer covid-19"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "told that the drug interaction pfizer covid-19 affected her right hip.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported received 2 dose of Pfizer Vaccine, 1st dose on 23Mar2021 and 2nd Dose on 13Apr2021, Patient stated after first dose she had debility with ambulation, brain fog and pain for 2 days. with receiving 2nd dose, Patient reported Continuous brain fog, pain and of debility with ambulation for 5 days. She was only capable of ambulating from bed to bathroom. She had a drug interaction with pfizer covid-19, 2nd injection, which was admin 13Apr2021. Several mris and blood work was collected, and pt. was told that the drug interaction pfizer covid-19 affected her right hip.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Follow-up information included recovery status.  Information regarding PREVNAR was received from a healthcare professional regarding a 23-year-old female patient who administered the PREVNAR instead of PPV23.  She experienced heat at injection site, stiffness in left arm and injection site swelling.  The patient received a dose on 04-Jun-2007.  The patient's concurrent illness includes diabetes mellitus (Borderline).  Product was administered on 04-Jun-2007.  Concomitant medications were not reported.  The patient was administered the PREVNAR instead of PPV23 on 04-Jun-2007.  The following day, 05-Jun-2007, she experienced heat at injection site, stiffness in left arm and injection site swelling.  The patient recovered.  No additional information was available at the time of this report.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-DEC-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 did have reaction after receiving Hepatitis A vaccine 1st, then Typhoid vaccine 2nd. Patient became pale, slumped over in sitting position, and started having tremor of hands, and eyes rolled back for approximately 1.5 minutes. Patient did not experience fall as she was still in sitting position and LVN stood behind her, and RN stood in front of patient. Initially unable to get pulse ox read during incident, HR 50. Oxygen was administered via facemask at 10L, airway kept open. Dr. (doc of day) was alerted and CODE ALERT called. Patient became alert and oriented after 1.5min, spO2 100%, P65, R20, and states "I was dreaming". After incident, patient A&O x3, patient reports that she did not eat yet, and reports feeling of "lightheaded and dizzy after shots", states after shots she felt like "spiders crawling all over arm" and "felt blackout". Dr. assessed patient. Patient given apple juice, crackers, and water. Monitored in triage room until stable. Left clinic after 1 hour.
Patient presents 4/29 with right arm red, hot to touch, swollen from elbow to shoulder.  Arm is sore.  Symptoms started morning after infection given.  Appt made by PHN for child to see pediatrician 4/29/11 at 11:15 am.  Appt given to mother.
Pt vaccinated w/Recombinant 1 hr later developed angioneurotic edema of her tongue & neck; Also difficulty w/breathing & swallowing;
PFIZER COVID vaccine #1 given 04/08/2021, lot #ER8729; Pfizer COVID vaccine #2 given 05/20/2021, lot #EW0169; pt had a previous hosp admission from 12/22/21 - 1/7/22 for left calf pain and found to be positive for COVID on 12/26/21; received monoclonal antibodies and dc'd to home; back to ED on 1/11/22 with c/o dyspnea; O2 sats in 70s on RA; EMS called; O2 supplementation given; ABX and dexamethasone; transferred to hospital; O2 demands increased requiring intubation; worsening ventilatory and pressor requirements; worsening shock; pt passed away in the hosp; DC and med records sent, per VAERS request.
Hospitalized confusion and a cough, 101 F temp, hypoxia to 90%. Positive COVID home antigen test on 2/3. Remdesivir 200 mg day 1 and 100 mg day 2-5. and dexamethasone 6mg daily x 10.