chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VACCINE IS GIVEN TO A 17 YEARS OLD. PATIENT HAS NO SIDE EFFECTS ACCORDING TO HIS MOM.
Itching at the injection site and around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 15:30 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. It was unknown whether the patient was pregnant at the time of vaccination. Concomitant medications included paracetamol (TYLENOL) for unknown indication from an unknown date.  Allergies to medications, food or other products was reported as not aware of. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced itching at the vaccination site and around the vaccination site  (reported as nothing serious). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itching at the vaccination site and around the vaccination site was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HOSPITALIZATION AND DEATH RELATED TO COVID-19 AFTER BEING FULLY VACCINATED
This case was reported by a healthcare professional and described the occurrence of rash on trunk in a male subject aged between 50 and 59 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 9 September 2011 at 15:00 the subject received a single dose of FLULAVAL at 0.5 ml in the left arm. On an unspecified date in September 2011, less than one week after vaccination with FLULAVAL, the subject experienced rash on trunk. At the time of reporting the event was unresolved.
This case was reported in a literature article and described the occurrence of croup in a subject of unspecified age and gender born between 1974 and 2008 who was vaccinated with DTaP (manufacturer unspecified), MMR vaccine (non-gsk) and IPV (non-gsk). This case refers to a subject. Concurrent medical conditions included DiGeorge's syndrome and had a chromosome 22q11.2 microdeletion detected by fluorescence in situ hybridization assay. No further information on the subject's medical, family history or concurrent medication is available. On an unspecified date, the subject received an unspecified dose of DTaP (small content) (administration site and route unknown, batch number not provided), an unspecified dose of MMR vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 39 days after vaccination with DTaP (small content), MMR vaccine (Non-GSK) and IPV (Non-GSK), the subject experienced croup, fever and lymphadenopathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The author's conclusion stated that their data expanded the findings of smaller studies indicating that live vaccination of patients with DGS with mild-to-moderate immuno-suppression was well-tolerated. Prospective studies are needed to confirm their findings and offer guidance for live vaccination. Because this study included few patients with DGS with severe immunosuppression, further retrospective investigation of this population is warranted. This case is one of the 18 cases reported in the same literature article.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline", notes: known allergies: Tetracycline; Zithromax, reaction(s): "known allergies: Zithromax", notes: known allergies: Zithromax; Iodine, reaction(s): "known allergies: Iodine", notes: known allergies: Iodine; Feldene, reaction(s): "known allergies: Feldene", notes: known allergies: Feldene. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient has vaccine received and also received other medication in 2weeks. Patient has received Paxlovid as treatment medication.  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.
09/04/2002, Headache, fever 102 degrees, vomiting, lower back pain, discomfort to left eye. Treatment rest, fluids, and ultracet. On 09/06/2002 not improved at all. Seen again, dizzy, chills, N/V light sensitive, treatment rest fluids, if not improved will admit for IVF (not needed)
Had a Retinal Vein Occlusion in left eye within 30 days of second dose.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 39-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176), via an unspecified route of administration, administered in Arm Left on Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); fluticasone propionate, salmeterol xinafoate (ADVAIR) and salbutamol (VENTOLINE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : EW0153), via an unknown route of administration on Apr2021 (Age at vaccination 39 years) as single dose for COVID-19 immunisation. On 04Jun2021 09:00, the patient experienced had a retinal vein occlusion in left eye within 30 days of second dose. Patient was received injection as treatment for event. Facility type Vaccine was pharmacy or drug Store. Patient was visited to emergency room and physician office, Disability or permanent damage. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. The clinical outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient received a flu shot in her left arm, but pneumonia shot in her right. Her left arm was fine, but her right arm swelled up and continued to be swollen 2 days after vaccine received.
Patient states that the day following her anthrax vaccination her left ear became painful to the touch. Patient states that her left ear was painful inside and out. Patient states the pain became worse 4 days after vaccination and felt like her lymph node in the left side of her neck was swelling. Patient states the pain began to lessen 5 days after vaccination. Patient states the outer ear no longer hurts but the inner ear still hurts when using a Q-tip. Patient was recommended to schedule an appointment with her primary care manager for follow up to her ear pain.
Information was received on 19-APR-2017 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 were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 08-JUN-2011 at a pharmacy, as recommended for routine adult health maintenance 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 04-APR-2016, the patient was treated at a physician's office for an ongoing painful rash which was diagnosed as shingles. 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.
This was my second vaccine. The day after the shot I had the typical headache, sore arm, low energy. Then at this time mentioned I woke up with my head spinning and it made me nauseous. It is now 4 days later and I am still dizzy if my head isn't pushed against a pillow or it standing. I went to doctor, he called it vertigo, I went to physical therapist to see if he could fix it, he said my crystals were not out of place to be fixed.
Robust take. 10cm erythema, lymphangitis, severe pain requiring narcotic analgesics apprx. day 8. Resolved. Pt now deployed at overseas location. No sequela.
Temp. of 102, nausea, achy, gave Ibuprofen with piece of bread
Red swollen large bump on leg that faded in color but is still present, large and very hard one week later.
Around 11 AM on 3/6/21 I began to feel very tired and lethargic. As I had driven  back that morning, I returned home and laid down for a nap. Later in the evening, I was still very tired and lethargic. I had no pain, swelling, or redness around my vaccination site. By Sunday morning, 3/7/21 I was feeling fine and have not experienced any symptoms since.
EPILEPSY, UNSPECIFIED 4/28/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/10/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT  EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 4/10/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 15 year old female who on 18-SEP-2008 was vaccinated IM with the first dose of GARDASIL 0.5 ml (Lot# 660557/0072X). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient became pregnant and experienced a miscarriage. It was noted that the pregnancy was lost at 16-18 weeks gestation. Upon examination the fetus was found to have spinal bifida. The outcome of miscarriage was unknown. It was reported that the patient sought medical attention: seen by the practice. Upon internal review, the patient's miscarriage was considered an other important medical event. Spina Bifida is considered a congenital anomaly. Additional information has been requested.
Employee described malaise  and body aches the day after receipt of the vaccination (1/13/21). The symptoms were bothersome enough to keep the the employee out of work for one day.
No adverse event; Patient who received the bivalent dose instead of the 1st monovalent dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Treatment received: monoclonal antibody infusion.) in February 2021.    On 28-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose).    Over a year ago patient was tested positive for COVID-19 infection.  Concomitant product use was not provided by the reporter.  The patient received the bivalent dose instead of the 1st monovalent dose in error. The patient received the bivalent for 12 years and up.  No treatment details were provided.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 12-JAN-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # M000996, expiration date 07-JAN-2018, for prophylaxis. No adverse effects were reported.
From information received on 11/14/02, it was reported that a 40 year old female was vaccinated with FLUZONE on 11/6/02 and reported to the nurse that she developed chest pain and chest tightness. The patient was not evaluated by a physician. The patient reported persistence of symptoms and was advised to seek medical attention. It was not reported whether the patient recovered.
11:23am Pt C/O feeling hot and clammy and nausea, skin pink, warm and clammy, denies SOB, and chest tightness, no hives or itching present, A & Ox3 resps reg. No distress noted. This is her 1st shot of Covid 19 vaccine.  Right arm BP 80/38 P-104 PO 99% sweatshirt taken off, chair reclined, knees bent up. Charge nurse RN summoned. 11/25am BP 75/37 P71, PO 99%, consulted RN about giving Benadryl and she since she did not have hives, and is A& Ox3 to hold off.  RN  has access to med dispenser.  Pt states she takes Ativan for anxiety at night na Lamictal for mood stability.  11:26a,m BP changed to right arm due to pain to injection site, site asymptomatic.   BP 70/31 P 70 PO 99%, ice packs to neck and forehead. No Benadryl per RN.  11:28 BP 101/60 P 98 PO 100% continue ice packs.  11:30am BP 95/59 P 92 PO 100%.  11:36am BP 97/59 P 82 PO 100% decreased nausea states she is feeing more normal.  11:39 BP 93/61 P 80 PO 100% continues to be A&O x3 states she feels fine. 11:42 am BP 103/67 p 84.  11:45am BP 110/77 P 88.  11:51am BP 96/66 P 88 sitting up right with feet down, given water and crackers.  12:04 pm BP 105/64 P 83 PO 100% continue to feel better.  12:10 pm BP 98/67 P 86 states she still feels weak.  12:20pm BP 104/60 P 86 .  12:23pm BP 93/63 P 85 while standing.  12:34pm BP 95/55 P 91 She states she feels back to normal and ready to go.  Skin cool, dry and less pink.  Instructed if she begins to feel light headed while walking to stop and lay down with feet bent up, and if driving to pull over, call emergency services and lay down. Pt states she understands. 12:35 Pt walked out without difficulty.
I started having Hives, chills and extreme swelling of the lips. As of today 11.25.2009, I am still having hives and random swelling even though I take Zyrtec every day.
Injection site pain; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received bnt162b2 (BNT162B2, lot number: EK5730), intramuscular on the left arm on 17Dec2020 09:00 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced injection site pain and fatigue. Therapeutic measure was not given as a result of the events. Clinical outcome of the events was recovering.
Sluggish; Slight achiness; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and PAIN (Slight achiness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Had cancer 10 year ago). Concomitant products included METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) for Blood pressure high, MELATONIN for Sleep disorder therapy.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish) and PAIN (Slight achiness). At the time of the report, SLUGGISHNESS (Sluggish) and PAIN (Slight achiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Armor thyroid 30mg for thyroid, sleep tea for sleeping aid and melatonin to help sleep. Treatment medication was not provided for dose 1.   This case was linked to MOD-2021-322989 (Patient Link).
SHE PASSED OUT; FACE TURNED WHITE; LIPS TURNED PURPLE; MASSIVE MIGRAINES; BED WITH ACHES AND PAIN; FELL IN CHAIR; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 44 year female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: lot of allergies to things. The patient was previously vaccinated with Pfizer (BNT 162) (form of admin, route of admin, batch number and expiry was not reported) dose was not reported (dose number in series was 1), administered for prophylactic vaccination. On an unspecified date, following vaccination with Pfizer (BNT 162), the patient was sick for one day (dose number in series 1).  The patient received additionally covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:211D21A and expiry:11-APR-2022) dose was not reported (dose number in series 2), 01 total administered on 04-JAN-2022 at left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 04-JAN-2021, following administration of covid-19 vaccine ad26.cov2.s, her face turned white, lips turned purple and just passed out. She sat down and fell in chair. Pharmacist gave her lollipop to suck but did not gave anything to drink, 30 minutes later when they went home, she had massive migraines, chills and fever, she had bed with aches and pains (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face turned white, lips turned purple, massive migraines, chills, fever, and bed with aches and pains, and the outcome of she passed out and fell in chair was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220112619 and 20220112632.; Sender's Comments: V0- 20220112654-covid-19 vaccine ad26.cov2.s-She passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report was received from a physician assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 09-JAN-2018, the patient was vaccinated with an expired dose of GARDASIL 9 intramuscularly, (dose and frequency were not reported) lot # L036301 and expiration date: 20-DEC-2017. No adverse effects were reported. The relatedness between the event and GARDASIL 9 was not reported.
I was told I was getting a tetanus shot. Developed Nausea that worsened during the night along with fever, headache, swelling and tenderness at injection site.  11/15/19 symptoms improved slightly with OTC meds. However once worn off about 1pm - shallow breathing and tingling of lips - Tylenol taken and focus on breathing and symptoms  improved- Fever spike was 102.1. Gradually improving - 11/17/19 - fatigue and 99 temperature - arm is still swollen and tender.
Pt went to urgent care with chest pains and was sent to hospital. pt was hospitalized for a cardiac work up the day after being vaccinated with Pfizer. Presented to ER with chest pain, breathing issues, and a swollen lymph note under left arm.  Pt received the Pfizer shot in her left arm. Diagnosis Costochondritis related to the vaccine treated with nsaid and sent home.  Pain last a couple of more and has not completely resolve.  Pt returned to work 10/7/21
Face is swollen; Voice is scratchy; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy). At the time of the report, SWELLING FACE (Face is swollen), DYSPHONIA (Voice is scratchy) and DIZZINESS (Dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer reporting for self. This 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 about noon at left deltoid (reported as left shoulder) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received his first dose on 07Jan2021. On 21Jan2021 he tested positive for COVID. He was scheduled to receive his second dose of the vaccine today (26Jan2021), and he wanted to know if he can get the second dose as scheduled or did he have to wait since he was still in quarantine. After informing doctor he had tested positive for COVID, he spoke with his doctor and recommended he take diphenhydramine hydrochloride (BENADRYL), Zyterec-D, and Nasal Spray. There were no additional vaccines administered on same date of BNT162B2, and there were no other vaccinations within 4 weeks. The event did not require a visit to emergency room or physician office. Lab data included height: either 5ft 8 inches or 5 ft 9 inches on unspecified date. The outcome of event was unknown.   Information on the lot/ batch number has been requested.