chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching at the injection site, it's about 3 inches long; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site, it's about 3 inches long) in a 60-year-old female patient who received mRNA-1273 (batch no. 046B21A) for COVID-19 vaccination.     Medical history has not been provided.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site, it's about 3 inches long). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site, it's about 3 inches long) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Event treatment has not been specified. Concomitant medications have not been reported.
Patient is a 2 year old male brought in by father who presents with complaints of hives. Got flu shot today at 10 am - Quadr PF (FLUARIX, FLULAVAL) about 1 hr later developed rash; noticed first in stomach and groin area; raised and bumpy has been scratching at it has had flu shot previously; no egg allergy; previously received QuadrPF (FLUZONE) med: Benadryl 1 tsp at 12:30 pm; did not have anything to eat; only played with mounted toys in waiting room; right now its his nap time; was about to eat lunch and started to scratch; did not eat lunch rash is less raised and bumpy after benadryl;  Had seen ENT prior to iz apt had ears checked; tube still in canal had audio test also.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, ANTEROLATERAL WALL ACUTE ST ELEVATION MI, INFEROLATERAL WALL ACUTE ST ELEVATION MI, POSTEROBASAL WALL ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
shortness of breath, blew up today/I still have shortness of breath when getting up from sitting or bending; dizziness, blew up today; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath, blew up today/I still have shortness of breath when getting up from sitting or bending) and DIZZINESS (dizziness, blew up today) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, blew up today/I still have shortness of breath when getting up from sitting or bending) and DIZZINESS (dizziness, blew up today). At the time of the report, DYSPNOEA (shortness of breath, blew up today/I still have shortness of breath when getting up from sitting or bending) had not resolved and DIZZINESS (dizziness, blew up today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Blood pressure medication currently not taking. Treatment medication not provided. Patient was drinking a lot of water and sitting down to manage reported events. Patient had major tests done on her heart and everything is fine.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on  16 Jul 2021 included lab data, outcome of the event is still ongoing for shortness of breath.
10:35 c/o faint/dizzy/diaphoretic; BP 98/78 sitting; 10:42 BP 104/70 - placed in supine position; 10:45 BP 110/78 - skin day Aoxttt states feels ok; no dizziness/states feels ok.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old female with unspecified race. Initial information was processed along with the additional information received on 23-NOV-2021 and 24-NOV-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808020, expiry: UNKNOWN) 0.5 ml dose, (Dose Number in Series: 1),1 total, administered to right arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021 (5 months after primary vaccination with covid-19 vaccine ad26.cov2.s), the patient found to have no antibodies on test (coded to confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203438. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211150258.; Sender's Comments: V0: 20211149833-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial unsolicited report was received on 02 February 2015 from a healthcare professional (registered nurse). This reporter also reported one other non-serious adverse event which is captured in case number 2015SA013040, same reporter, same product, different patient. An unidentified patient, gender and date of birth not reported who is currently in their 30's received DTP vaccine as a child on an unreported date (manufacturer, batch, route and site of administration were not reported). The patient experienced a febrile seizure on an unspecified date and time. The patient's medical history and concurrent medications were not reported. Treatment details were not reported. The patient recovered on an unreported date. Documents held by sender: None.
Patient is a pleasant 78 year old gentleman with significant medical history of HTN and high cholesterol, who is known to Doctor for treatment of MDS, currently treating with Dacogen days 1-5 q28 days. He last received C7 on 1/31 thru 2/4. His last bone marrow biopsy from 9/28 after 3 months of treatment, showed stable MDS  disease with 5-10% circulating blasts. He also has a known history of PE and has been treated with multiple lines of therapy, most recently Lovenox. It has been on hold due to platelets >50k and history of bleeding. He requires transfusional support for his anemia secondary to MDS. Most recent transfusion was 2/4. He arrived to ER today via ambulance with complaints of lethargy, weakness, sob and fevers. He complaints of lightheaded with standing. He reports + COVID test on Monday 2/7. Upon arrival, he had a fever of 102.6. BP and HR were stable. O2 98% on 2 L. He does utilize supplemental oxygen at home and his oxygen need has not increased. His CBC showed anemia and thrombocytopenia. We will admit for IV antibiotics, transfusions, and close monitoring in his immunocompromised state with chemotherapy.
polio-onset p/vax;pt exp residual weakness of lt calf muscles & has been treated in a short leg brace w/an anterior stop on the lt;dx calcaneal deformity of lt foot d/t poliomyelitis;
Anaphylactic reaction; her throat begin to close; 1st:Sep2021,On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine; 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 parent.  A 18 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller also reports patient has history of asthma and allergies.; "Allergies" (unspecified if ongoing), notes: Caller also reports patient has history of asthma and allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Sep2021, when the patient was 18 years old, for Covid-19 immunization, reaction(s): "Anaphylactic reaction". The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "Anaphylactic reaction"; THROAT TIGHTNESS (non-serious), outcome "unknown", described as "her throat begin to close"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st:Sep2021,On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine". The event "her throat begin to close" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: allergy test: (14Dec2021) she was not allergic to peg and polysorbate. Therapeutic measures were taken as a result of anaphylactic reaction, throat tightness. Clinical Course: On 14Dec2021 she received allergy testing that resulted she was not allergic to PEG and polysorbate therefore her allergist said it was ok to get a second dose of the vaccine. Following the second dose within 35-40 min after they left the facility and got home her throat begin to close and again required an epi pen and went to the ER for treatment to open her throat. Caller reports no residual side effects. Her allergist thinks maybe it is a combination of PEG and polysorbate together. Patient mother reported that her daughter had experienced anaphylaxis after both doses due to the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache, Arthralgia, Fever, Chills, fatigue Narrative:
Heaviness in chest, site soreness, headache, fatigue, generalized muscle aches and neck pain.
The pt experienced a fever with a seizure 72 hours post vax. The pt also developed a URI one day post vax.
C/O THROAT CLOSING, IMPROVED, VSS, SYMPTOMS RESOLVED, NO TRANSPORT
Patient felt a breast mass 4 months after her covid vaccine.  Already netastatic to ax nodes.  Required surgery
To Whom It May Concern: My daughter went to our nurse practitioner at Health Care Center on March 31, 2008 for a sore throat. She complained of her throat for about two days prior. Pt would get pharyngitis and strep about twice a year since she was 13. She received a shot of ROCEPHIN in the office on March 31st as well she was given a prescription for ZITHROMAX (Z-PAK) at the same time. I'm not sure exactly what time her appointment was it was around 11:00 am. that day. She dropped off her prescription at the pharmacy and I picked up on my way home. She took her first dose of ZITHROMAX on the 31st. She stayed home from school the next two days. She slept late both days which is not abnormal for her. In the evenings we played rummy, she was congested and coughing a little. She complained of a headache the next night and I gave her some ibuprofen. On Wednesday April 3rd she went to school, (school gets out at 3:05 p.m.) after school she went to tract practice. Her tract practice was a short one, I know she ran but I'm not sure how much. She stopped at a convenience store on the way home from school and got a Red Bull. She went home and changed clothes for work. She called me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being blocked due to rain where we live. She parked her car and was walking the short distance into where she works she collapsed and started seizing. A lady in the drive through told the owner that she had fallen and he went out immediately. He said she was shaking, the employees inside called 911 and then me. The owner told me she stopped shaking and took a few strained breaths and then went limp. The police officer arrive within three minutes, he was a first responder. He did not check for a pulse or attempt CPR (I am in the process of getting a police report as well). Just as I got there an off duty paramedic arrived and started CPR. It took quite awhile before the ambulance arrived; she had been down too long. I later learned that they did not get her heart started until just before the ambulance arrived at the hospital. Pt officially died on April 7th, the decision was made on April 6th that she become an organ donor. My daughter was a very healthy, vibrant, and beautiful person! Any other information you need I will do my best to provide. I STILL have not received the autopsy report. I did talk to them Friday and they said it would be within the next two weeks. Sincerely, pt's mother  9/19/08 Autopsy report states COD as apparent cardiac rhythm disturbance of undetermined etiology.  Report states pathologic findings of: hx of sudden fall & cardiac arrest; subgaleal hemorrhage, fontoparietal scalp; tongue abrasions c/w tooth marks; hx of recent illness; agonal seizures; bilateral cerebral edema; catecholamine induced myotoxicity; bilatreral lobar pneumonia; organ & tissue harvesting.
Per patient's report via a message to clinic, "I had my annual physical yesterday, and along with it, the shingles vaccine. I had disturbing symptoms last night. If they're related to the vaccine, perhaps it could be noted for the benefit of other patients. If it's something else, maybe it's something I should investigate further. Lying in bed on my left side, I was jolted by an intense, stabbing pain in my chest. This was on the far left side, at the edge of what we might call the chest, a couple of inches below the armpit. The vaccine had been administered into my left shoulder. The stabs continued until I shifted to my back, where they became softer. When I rolled to my right shoulder, they ceased. I experimented with this for a while, and it was consistent. There was no change in sensation in my left arm; it felt normal. Other than pain, there were no other symptoms (except letting loose about five large burps over a couple of minutes, which then stopped). Four hours later, I must have rolled back to my left in my sleep, because the stabs jolted me awake. I noted that they flared, to varying degrees, whenever my heart pumped. That was kind of freaky. I tried applying pressure, while continuing to lie on my left side, jamming my right fist between my armpit and the pain area and the symptoms stopped. After 20 minutes, I removed the hand, and the symptoms stayed gone. Today, other than a sore shoulder, everything is normal. If this is something to get checked out, let me know. Otherwise, faux heart attack might be listed in symptoms of the vaccine."
Faint; Heart problem; Whole left side just had pressure, pressure from all around my left breast and my back, down my arm, my ear; Headache; Don't really have the energy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 27Apr2021 (Lot Number: ER8736) as single dose for COVID-19 immunisation. Medical history included thyroid, COVID (patent was almost 100 percent sure that she had COVID before but she did not know for sure because she had not been tested for antibodies). Concomitant medication included levothyroxine sodium (LEVOTHYROXINE NA) taken for thyroid. The patient stated she got the Pfizer shot on the 27Apr2021 and she had a reaction to it, heart problem and she really did not think that she might have had, she was almost 100 percent sure that she had COVID before but she did not know for sure because she had not been tested for antibodies. But she just really had a terrible effect and she did not know what was the next step. She meant her whole heart, she fainted, her whole left side just had pressure, pressure from all around her left breast and her back, down her arm, her ear. She had a headache and she gave it a couple days and she was feeling better today (03May2021) but she did not really have the energy. No treatment received. Due date for the next shot is 18May2021. Height and weight were reported as 5 (feet) 3 (inches), and 135 (pounds) (That's just an estimate per patient). Outcome of the events was unknown.
I developed a soreness/swollen feeling in my lymph node in my left arm pit (same arm as shot) that lasted about 14 hours.
following vax pt devel t103 ax; unconsolable for 1-1 1/2 days during that time pt had unusual cry;
Information has been received from a registered nurse concerning an 11 week old child who was vaccinated with one dose of PNEUMOVAX (lot # not reported) due to nursing error. The nurse reported that the nurse who gave the vaccine was a new employee who was not used to administering vaccines, and that this was a human error. No adverse effect reported. This is one of two reports received from the same source. No additional information is expected, the physician could not be contacted.
headache; an extra (third) dose of Menactra administered to patient; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 18 years old male patient who experienced headache, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On 30-May-2019, the patient received a third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6179AA via intramuscular route in the right deltoid.  On an unknown date, the patient developed a non-serious headache following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was also the case of medication error due to extra dose administered.  (Other relevant tests included no lab data.)  Final diagnosis was headache.   It was not reported if the patient received a corrective treatment.  On an unknown date, the patient was recovered from headache.  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 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.  Documents held by sender: none.
PT SAID SHE HAD PAIN & SWELLING IN THE ARM IN WHICH SHE RECEIVED THE PNEUMOVAX IMMUNIZATION.
temp 102.6, h/a, nausea, diarrhea, vomited x 3;
I developed  a rash about7-10 days post injection. It started in my antecubital  area then spread down my, back of knees and legs. I treated it with over the counter hydrocortisone cream which did help but when I would stop using the cream the rash would return. Th rash was extremely  itchy and I was scratching so hard it would bleed. I wanted 2 months before I finally went to a dermatologist. She put me on a prednisone taper and  a prescription steroid cream.  I finished the prednisone on June 13,2021. The rash did clear up for awhile but I still have some break outs of the rash.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was on Paxlovid treatment on unspecified dates in Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350680 same patient, different drug/event (Paxlovid Case);
Information has been received from a licensed practical nurse concerning her 16 year old daughter with DURICET allergy and no pertinent medical history who on 03-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 653650/0702F). There was no concomitant medication. Subsequently, sore throat was experienced first followed by the rashes all over her body in August 2007. After rash appeared, strep was ruled out, but the patient was still given (LEVAQUIN) for sore throat. The patient recovered from the sore throat in August 2007, but did not recover from the rash until mid-September 2007. The rashes lasted for 1 month. The patient sought medical attention by contacting physician. Additional information has been requested.
arm became swollen, red, and hot . also had rash down arm. went away after a week
This spontaneous report was received from a licensed practitioner nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 16-MAY-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot# L042257 with expiry date on 17-AUG-2018, (strength, dose, route and anatomical location were not reported). Concomitant medications were not reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
I had minor headache as well as moderate fatigue for a couple of days. However, on 4/10-4/11 I notice the vocid arm. A large swollen red circle around the injection area on left arm. It started off as an 1.5 inch wide circle then spread to 5 inch the next day. It's fading away but the itchiness still happening. I have been applying ice and itching cream so I won't scratch it.
Patient has fear of needles/vaccines. Anxiousness prior to injection. Patient felt faint after vaccine and was very sweaty. Says he had a panic attack. Pt was given water and put his feet up. Patient fully recovered.
Redness, swelling, warmth, induration and pain at site of MCV. 3cm x 5cm (L) deltoid.