chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse (R.N.) and by telephone concerning a 22 year old female patient with a history of seizure for which she was on therapy.  On 23-MAY-2007 patient was vaccinated with a first dose of GARDASIL and on 23-JUL-2007 she was vaccinated with a second dose of GARDASIL in another doctor's office.  No lot number was provided.  Concomitant therapy included TEGRETOL, DIAMOX and YAZ.  The nurse reported that on 29-JUL-2007, patient had a seizure type episode six days after she received her second dose of GARDASIL.  The patient sought unspecified medical attention.  She reported that patient had no seizures since this incident.  No further information was provided.  Upon internal review seizure was determined to be an other important medical event.  Additional information has been requested.
Patient developed a small "pimple-like" rash at injection site. Was about the size of a dime shortly after administration, and when reported 4 days later, the "rash" is about 2-3mm diameter. Patient states that it hurts slightly.
I was given the vaccination 02/03/2021 in the left deltoid and had a sore upper arm the first 24 hours.  I had not had other symptoms until about 2PM 2/11/2021.  I developed some mild itching in the left deltoid region, and it persisted through the evening.  I noticed that the area had become red and somewhat swollen, and it was approximately 5cm in diameter.  I did use a cold pack a couple times last evening after that.  This morning, it was still present and was about the same size, but it was not quite as red or warm.  There is still some mild itching, and I have used a cold pace twice.  I do not have other urticaria and I do not have any respiratory symptoms or other concerning symptoms.  I am continuing to monitor the area.  I have not contacted my physician since it has not progressed.
tested positive for COVID after the 1st dose of Pfizer.; This is a spontaneous report from a consumer or other non hcp.   A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3246), via an unspecified route of administration left arm on 20Jan2021 09:45 at 0.3 mL, single dose, for COVID-19 immunisation. Medical history included obesity, hypertension. Concomitant drugs were not reported.  No other vaccine was received in four weeks.  The patient experienced tested positive for covid nasal swab test on 28Jan2021. The patient was hospitalized for 4 days. Patient was treated with oxygen. The outcome was recovering.
On 7/30/22 he vomited 3x and had no fever, several wet diapers. On 8/3/22 he had nasal congestion, cough, and was feeling uncomfortable and was in pain. Took him to Pediatrician the next day and he diagnosed with a double ear infection and just kind of looked like most allergies. They prescribed antibiotics for the ear infections.
had the vaccine and has had shingles/Suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporters comment:  The case was reported by the patient's son/daughter via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles twice. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Heart Palpitations--very frequently at times with felling of not being able to catch my breath
Recipient experienced hot flashes and itchy hives.  On -site EMT called for ambulance.  Given 50 mg Benadryl at 12:10 PM.  Transported by ambulance to ED.
Heartbeat was double my normal while resting Severe headaches,  extreme pain in back into  upper legs, hard to move
Pt vaccinated w/Engerix-B developed mild myalgia and arthralgia and 100 degree temperature with the first dose.  After second dose, symptoms became more pronounced and she experienced polyarthritis for 2 weeks.  Recovered with no sequelae.
pt states they experienced fever, chills, nausea, achy. they also stated infected injection site and went to urgent care twice for antibiotics. hives for 2 weeks and hot arm.
Pain heightened; limbs she feels a little tingle/tingle in her face/face tingling; in her face, there is the warmth; This is a spontaneous report from a contactable consumer (patient).   A 38-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:01 (Batch/Lot Number: EN6281), at the age of 38-years at vaccination, as SINGLE DOSE for COVID-19 immunisation.  Medical history included ongoing Low blood pressure, she has this about 8 months, ongoing impaired Gastroparesis,had this about 2 years and takes medication for it,  nerve damage in her stomach also, it is to stop abdominal cramping . Concomitant medications included amitriptyline taken for nerve injury, abdominal pain from 29Jan2021 and ongoing. The patient said she had a nerve damage before getting the COVID vaccine shot. She noticed that after getting the first dose of the vaccine the pain heightened, wanting to know if we have information regarding this. She feels the shot has exacerbated the feeling. In her limbs, she feels a little tingle and in her face, there is the warmth she associates with the nerve damage. She is wondering if this is this something we have seen happen. The caller confirms that the first dose was given at 9:01am. The tingling started about 5-10 minutes after the dose was given. It is basically in the face, that is where she notices it the most. The prior nerve damage is on her right side from the top of head to her hip. She explains that right now she mostly noticed in the face tingling and it is about the same since it started. In her legs, they was a little tingle when walking out, after the 15 minutes. This was in both legs and it is still there but she doesn't notice this as much since she has just been sitting there. The outcome of the events was unknown.
About 5 min after Flu vaccine after vomited x2 and looked very pale - after 15 min vomited more and looked pale and lethargic. No stridor, wheeze, rash. Given epinephrine to 2 in office EMTS took to hospital, he received fluids.
Information has been received from a physician and a nurse concerning a 10 year old female who on 02-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck), lot# 657796/0842U), second dose, single dose vial. Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and human papillomavirus vaccine (MSD). In 2007, the patient developed a nodule and experienced injection site pain and swelling. As of 23-AUG-2007, the patient recovered. An initial dose was administered however not reported. Additional information has been requested.
pt recv vax & 48hr p/vax pt exp dry cough & SOB for 1 day;
This case involves a 2 months old male patient who received 0.5 ml dose of DTAP -IPV portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] due to the products not being mixed together (lot: powder: UJ425AA, expiry date: 21-May-2022) via intramuscular route in the left thigh for prophylactic vaccination on 14-Jun-2021 (Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE 13V for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day). At the time of report, no adverse event was reported. The caller stated that the liquid portion of PENTACEL was given to a 2-month-old infant. The vaccine was not reconstituted and caller wanted to know if the infant needed to be revaccinated. The patient only had the DTAP -IPV portion and not the HIB portion due to the products not being mixed together. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Right upper arm erythema x 5 days. Ibuprofen 400mg every 6 hrs.
Reported event to EHS on 10/14 at 2:45 pm. Received Flu vaccine on 10/13/15 at 3 pm. Reports that "12 hours" later felt faint and "almost passed out". C/O headache to day and achiness at site of injection. Advised to see Primary Doctor if symptoms persist. Reports hx of vasovagal response in past.
Allergy to vaccine; Pruritus allergic; Allergic rash; This spontaneous case was reported by a physician and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
pt has a "lump" at the site of injection and as of 5/19/2021 has "heat" at the injection site.  Has not used any ice/heat to area as of yet.  advised to seek md advise if continues or worsens.
A week later the injection site became itchy; A week later the injection site became itchy and red; Injection site arm hurt real bad, pain lasted for two days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (A week later the injection site became itchy), VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days) and VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL /HCTZ) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days). On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (A week later the injection site became itchy) and VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 13-Mar-2021, VACCINATION SITE PAIN (Injection site arm hurt real bad, pain lasted for two days) had resolved. On 26-Mar-2021, VACCINATION SITE PRURITUS (A week later the injection site became itchy) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (A week later the injection site became itchy and red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took Benadryl pills and applied Benadryl cream for 2-3 days for itchiness.
Pt.'s Mother states that after receiving *Above Listed Vaccines 08/11/2021, started experiencing symptoms weakness while walking, fever (skin hot to the touch), nausea, fatigued, and incoherent. Most symptoms have subsided but remaining weakness/dehydration. No noted Primary visit.
Patient got both flu and pneumonia shots on 9/12/10. She came to pharmacy and showed her left arm, where she got the flu shot. Her arm was swollen, red, painful, and warm. She had to take some BENADRYL and she was followed-up 2 days later. Her arm is okay now.
Lethargy, extreme irritability within 2 hours of immunization- lasted for 2 days. Regression of language for 3 weeks
Patient states that the day after the vaccine when he would stand or move that his equilibirum was off, causing him to stumble. He described it as if he was "drunk" and stumbling without the alcohol as he does not drink.
diagnosis : acute resp failure with hypoxia; acute covid; community acquired pneumonia, copd exacerbation, ung cancer, RLQ abd pain, severe malnutrition He was admitted 8-11-22 (er on 8-10-22) and deceased 8-28-22.   Came with shortness of breath, cough, fever, chills and given IV antibiotics,  IV steroids, oxygen,    HE had been in Hosp previously and given dx of unknown lung cancer.  8/12 pleural bx showed adenocarcinoma from pulmonary source. started carboplatin Alimta.  Ptient weak.  He became tachycardic and tachypneic and code status discussed and DNR was decided.  Did not want to be intubatedv  He testd + for covid 8-20-22.    comfort care.  deceased 8-28-22
Redness around injection site > 2 inches and had T-101.  Crying.  Redness and swelling resolved without tx and was without c/o on 12/2/02 per T/C with GF of client.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pcos" (unspecified if ongoing), notes: Polycystic ovary syndrome; "obesity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken included Paxlovid from 29Jul2023 to 03Aug2023 as treatment of COVID-19 and other medications included Advil Tylenol, Omeprazole, Mucinex.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
pt recvd 3 doses of Engerix-B as well as 2 boosters & obtained no response;
Fever - Pustules; Varicella outbreak after vaccination; Motrin - Tylenol
Pain in lifting arm starting about an hour after shot. Experienced Tenderness and redness at injection site. By 10 pm same day I had a fever of 100.4 (including chills) and was very fatigued.  Next day the fever continued and I was lethargic all day.  Fever came down to on Sunday to 99.4 .  Left arm is red, warm and swollen, about the size of a tennis ball.
Patient had no reaction immediately after injection.  Approx. 36 hours after vaccination she noticed swelling at injection site.  Overnight she then experienced bleeding from injection site, as well as swelling and itching.  She did experience some red streaking around site.  Site is still red and sore.  I referred her to her primary care provider.
COVID Vaccine Breakthrough Case  Moderna Dose 1 3/24/21 (007B21A) Moderna Dose 2 4/21/21 (048B21A) COVID Positive 10/27/21 COVID Positive 10/29/21  11/2/21: The patient presents with Shortness of breath. Onset: 10/26/2021 .  Location: generalized. Context: Patient arrives to ED with complaints of shortness of breath since 10/26/2021.  Associated symptoms: cough, headache, decreased appetite, body aches, intermittent fevers, chills, sweats, lightheadedness, dizziness. Patient reports she is COVID positive.  Patient reports she does not feel she is getting any better.  Oxygen level 92-95%. Patient denies nausea, vomiting, diarrhea, abdominal pain, urinary symptoms, chest pain.  Aggravating factors:  None. Relieving factors:  None.  Treatments: Azithromycin, Tessalon Perles, prednisone..  Timing: gradual. Character: moderate.  Modifying Factors: no change and RX/OTC: positive.  Associated Symptoms: See above.  11/14/21: Patient is a 56 female with pmhx of hypertension, obesity, hyperlipidemia, rheumatoid arthritis and hypothyroidism coming in for shortness of breath for a few days.  COVID-19 pneumonia with secondary community-acquired pneumonia, admitted to icu with pulmonary consult  s/p remdesivir, rocephin, tocilizumab, dexamethasone  -required high flownasal cannula, now weaning off  - prn albuterol MDI   Acute hypoxic respiratory failure -s/p tocilizumab  - requiring supplemental oxygen to maintain oxygen saturations greater than 90%  - home oxygen walk test-desaturated to 81%, requires 3 liters oxygen  Arthritis, rheumatoid- on xeljanz at home, methotrexate, leucovorin, hydroxyurea, will hold for now  Essential hypertension-  stable and continue medication  Hypothyroidism -resume synthroid dose  Mixed hyperlipidemia-  on statin, lft's ok   dispo- lovenox 40 bid for dvt prophylaxis while inpatient  -full code  -POA daughter  -advised to follow up wiht her rheumatologist and pcp
severe numbess, tingling, shooting pain in hands and fingers. pain in left arm at injection site
24 hours following receiving my vaccine, I got my period 5 days early. The period was heavier than normal and came on quicker.
Sudden pain in throat. Couldn't swallow. Talked with difficulty. Alternating fever and chills with trembling.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 came in for first shot of pediatric covid shot, after getting the vaccine, patient became extremely anxious, tired, almost fainted.
Narrative:  COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, Pfizer, dose #2 08/06 pt cc: cough, chills, diarrhea, fatigue, fever, loss of taste or smell, myalgias, rhinorrhea, dyspnea exposure: unknown 08/07 - 08/20 pt symptoms continue 08/16 COVID swab, result: detected 08/16 COVID swab, result: detected 08/16 CXR impression: No evidence of acute cardiopulmonary process. 08/23 DDIMER result: <0.22 08/23 PROCALCITONIN result: <0.05 08/23 FERRITIN result: 197.5 08/23 pt admit to ED cc: dyspnea dx: shortness of breath on exertion, fatigue, chest tightness LOS: 1 day
Numbness in entire right leg and foot. Went to my doctor after 3 days,  nurse practitioner checked strength, reflex,  and other vitals. and found everything normal and suggested to wait and see how it  progressed.  My walking seems normal overall but numbness is annoying. It is now 10 days since shot and it is somewhat better but still  present.
Information has been received from a licensed practical nurse and a consumer concerning a 11 year old white female twin who on 06-AUG-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 661445/0525X).  On the same day, the patient received a dose of GARDASIL (lot # 659435/1265U), left deltoid, received a dose of VAQTA (lot # AHAVB243AA), the patient was vaccinated also with the fifth dose of ADACEL (lot # C2995AA) and received with a dose of MENACTRA, (lot # 42544AA).  On 07-AUG-2008, the patient experienced redness in left arm, pain and swelling at the injection site.  The patient may have also experienced fever and/or itching and burning while getting injected with the vaccine.  On 09-AUG-2008, the patient recovered.  The reporter has requested a lot check due the patients having adverse experiences.  The patient sought medical attention by calling the office.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question 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 the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reported provided by the same source.  The patient's twin also experienced adverse events.  (WAES# 0808USA03476).  No additional information is expected.
Mother states child had fever 101 degrees, hard to breathe at night, baby taken to Hospital, admitted for "early onset of pneumonia", treated stream tent, Pedialyte and Tylenol and discharged 2 days later.