chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive with Omicron; tested positive ; pretty frazzled moments; 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 (159558; 172086).  A 96 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "tested positive with "; FATIGUE (non-serious), outcome "unknown", described as "pretty frazzled moments". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for , notes: positive for .  Clinical course: The reporter stated that his mother contracted Covid a little while ago and his mother got pretty frazzled moments. He stated that Paxlovid was not yet available in their area and the nurse at the hospital did not know where to get Paxlovid.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Subject reports being tired on the first day after receiving the ANTHRAX vaccine. At 6:20 AM on the second day she noted chest pain and shortness of breath while walking. other symptoms reported include cough, dizziness and continued tiredness. Subject presented to Emergency Room. Chest X-ray, EKG and blood work were performed and were reportedly normal. On days 3 and 4 she continued to experience chest pain and SOB with cough on exertion. On day 5 post-vaccination subject reports no chest pain, mild SOB with rare cough continues along with tiredness. Subject also reports redness and swelling at injection site which began on the first day following vaccination and continued to date. 10/30/2008 Contacted subject who reports that she saw her personal physician, was prescribed Diclofenac and all symptoms have resolved.
FIRST SHOT BODY ACHES SWOLLEN INJECTION SIGHT AND HEADACHE FOR 3 DAYS SECOND SHOT SWOLLEN REDNESS IN INJECTION SIGHT,  SEVERE CHILLS WITHIN 24 HOURS,  FATIGUE, HEADACHE FOR 6 DAYS
On Thursday, 4/1/2021, client received her first dose of Pfizer COVID vaccine (LOT # EW0150, EXP 7/2021) at approximately 10:07 am by vaccinator RN.  RN instructed client to self-monitored at the observation area. EMT found this 38 years old female in an observation chair sitting upright and requesting assistance. Due to the client needing translator, site manager present provided translation. lead RN came to assist EMT as needed. EMT reported client had a chief complaint of lightheadedness. Client stated that she felt like her head was "big" but that she did not feel like fainting. Client stated she had a history of high blood pressure and diabetes type 2 but did not take diabetes medication. Instead, she stated that she managed it strictly with her diet. Client had no known allergies. Assessment revealed no redness, hives, swelling, shortness of breath, chest pain or other signs of anaphylaxis throughout her body. Client denied having a headache but stated that she felt "hot" and that the heat was rising to her head. Client denied having a meal before her vaccination. Initial vitals were as follows: Alert and oriented x 4, Eyes were PERL (Pupils Equal and Reactive to Light) at 4 mm, pulse - 74, regular and strong at radial, O2 - 99%, blood pressure 160/98, Temperature 97 F,  Respirations 20 and regular. Skins were warm and mildly sweaty. Client consented to staying present for an extra 30 minutes after incident onset. Staff present verified that client had no food allergies and was provided food to eat while under observation. Client's vitals were monitored at 5 minutes intervals after the onset of the incident as follow: 10:18 am: 160/98 (Blood Pressure) , 74 (Heart Rate) , 99% (Oxygen), 20 (Respiration), 97 F (Temperature); 10:23 am: 162/98 , 68 , 99% , 18; 1028 : 162/98 , 68 , 99% , 18; 1033 : 162/98 , 72 , 99% , 18; 10:38 am: 162/98 , 72 , 99% , 18 , 98 F; 10:48 am: 162/98, 72, 99%, 18. Client reported at the end of her observation that she no longer felt hot and her head sensation was gone. Client's temperature improved from 97 degrees Fahrenheit to 98 degrees Fahrenheit and she ceased sweating at the end of her observation period. Client's husband was present and both were provided a Pfizer vaccine fact sheet and instructed to seek out medical advice or emergency care if a severe allergic reaction occurs later in the evening. Client left with husband in no apparent distress at 10:48 am with husband stating he would drive them home.
Pt was given shots on 10-2-17 and per mom pt had ran slight fever after shots but on 10-4-17 pt ran a fever of 105.3 with TYLENOL per pt mom reports. Pt was taken to local ER for evaluation and per mom reports that ER doctor told her to give TYLENOL and Ibuprofen for fever. Pt's mom said that fever broke on 10-6-17 but pt broke out in a rash on 10-6-17 from head to toe. Pt's mom described rash to be "like an eczema rash but it is not eczema". Pt mom reports to Health Department Immunization Nurse on 10-9-17 that "his rash has faded but it is still there and he has not ran a fever since 10-6-17." Pt mom was told to take pt to be evaluated by his pediatrician's office where he received the vaccines.
Patient felt like she was having trouble breathing, stated it felt like someone was sitting on her chest. didn't feel like throat was closing, but felt anxious. asked patient if she would like benadryl, she stated yes. sat for 20 minutes after receiving benadryl and felt okay, felt like her trouble breathing went away.
Chills; Vomiting; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2nd via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 Immunization. The anatomical location was left arm. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 04:45 AM, anatomical location was left arm. The patient's medical history and medication was not reported. It was reported that the patient experienced chills and vomiting on 16Feb2021. Patient was not Pregnant at the time of vaccination. The event assessed as non-serious by the reporter. Patient did not received any treatment or any other vaccines within 4 weeks prior to the COVID vaccine. After the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products.  The outcome for the events was not recovered.  Information on the lot/batch number has been requested.
4-16-13: Red area (L) upper thigh (IPV, VARIVAX) 4-17-13 increased size red area, tender, warm to touch 6 cm x 6 cm. Positive blanches. Treated w/Abx for possible cellulitis.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Age 17 years 11 months and 5 days old at time of second dose Moderna vaccine. Patient here with father. Reports no complaints following his first dose of Moderna.  Patient here with father. Advised that he was under the required age 18 for vaccine.
Patient started having visual changes approximately an hour after receiving vaccinations and was seen an ophthalmologist a few days later (because of the weekend - she received vaccines on Friday 12/20/2019) and had a L side torn retina and received laser eye surgery at that time in ophthalmologist's office and then a 2nd laser surgery about a week after that.
Patient, called nurses desk, requesting a nurse, the nurse went to the room, and observed hives, over the patients face and buttocks.
Allergy red patches on the skin itching, hives, sore throat, and difficulty in swallowing saliva, severe pain in the area of the vaccine and cough with yellow phlegm, desire to eat and very thirsty.no
Patient had a seizure with high fever on 7/10/20 at around 3:30am.
First, I developed an extremely sore shoulder for about 1-2 days after the second dose. It was surprisingly painful to lift my arm during that time. I've had many vaccinces, and none caused the level of soreness and pain in my should that I experienced with this one. By the evening of the second dose, I also felt very run down, like I was getting sick. The day after the second dose, I had very low energy, like I was just starting to get over a bad illness. Gradually this feeling of being tired and rundown faded over the next week.  I did not have these symptoms anywhere close to this intensity after the first dose.  In addition to those clear reactions, for about 1-2 months after the second dose, I also found it generally harder to focus on my work and had a very slight fluttery feeling in my chest. This was a stressful time for me since I was selling my house and moving, and I thought it might be due to stress. However, after reading about reports of myocarditis after COVID-19 vaccination, I can't help but wonder if my mild symptoms of trouble focusing and a fluttery chest over these 1-2 months were a mild case of myocarditis. It was not affecting my daily life too much, and I was very busy at that time, so I did not see a medical professional about it. However, I am filling out this form as I believe this is something that should be closely watched, and even brought to attention as a possible symptom to watch for those getting vaccinated. Had someone told me that myocarditis might happen, or even there was a way to report possible reactions, I probably would have made time to see a doctor so the science of these vaccines can be better advanced.
pt recv vax 22OCT97 & 22OCT97 pt exp an inj site rxn which consisted of wheal like, red hives that spread below the knee;infant was treated w/hydrocortisone cream & sx resolved;
pt states that she has a 3" hive around the injection site with itching,  and redness.  She has soreness from left arm to chest. She will contact PCP
Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; Swelling and redness and itching at injection site; product=COVID 19, brand=Pfizer, dose 1 administration date: 27Dec2020, dose 2 administration date: 13Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 13Jan2021 at 17:00 at a single dose for COVID-19 immunization. Relevant medical history included thyroid cancer. The patient has no known allergies. Concomitant medications included thyroid (ARMOR THYROID) and ibuprofen (ADVIL). The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) on 27Dec2020 at 10:00 A.M., in the left arm for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital.  The patient has not been tested for COVID-19 since vaccination. On 14Jan2021 at 09:00 A.M., the patient experienced swelling and redness and itching at injection site. The patient did not receive treatment for the events. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
initially same day, 2/24/2021, had "severe weakness and numbness in right foot". she felt like she was dragging foot. This was transient. Sunday morning, 2/28/2021,  her left arm was itching and started getting red. symptoms worsened so saw PCP and started on keflex
Report  describes autism in a pt who rec'd diphtheria and tetanus Toxoids and acellular pertussis vaccine absorbed (Infanrix). There was not relevant medical history. Concurrent conditions and medications were not specified. Vaccination history (included immunizations with diphtheria and tetanus Toxoids and acellular pertussis vaccine absorbed (Tripedia on 10/27/99 (lot 7389AA), 12/29/99 (lot 7389AA), and 3/01/00 (lot 7387AA); inactivated poliomyelitis virus vaccine (IPOL on 10/27/99 and 12/29/99; combination Haemophilus influenzae type B conjugate/hepatitis B vaccines Comvax, on 10/27/99 and 12/29/99; and Haemophilus on 12/12/00, the pt rec'd his 1st injection of Infanrix (lot DTAP961A2). He also rec'd his 3rd injection of IPOL and Comvax, and his 1st injection of MMR vaccine. Just recently, the pt has rec'd a dx of autism. As of 2/8/02, the event had not resolved. This report of autism is considered medically serious by the manufacturer. Follow-up infomation from a registered nurse on 3/6/02, noted that the patient had been diagnosed with autism "within the last 6 weeks", approximately January 2002. The mother of the child called the registered nurse to obtain information on the thimerosal content within the vaccines that the child had received. Additional information has been requested. Followup information from a woman in a physician's office noted that the patient di dnot receive the Haemophilus B conjucate vacceine (+) hepatitis B vaccine recombinant at this office. Follow-up information received on 3/28/02, from a registered nurse indicated that on 12/12/00 the patient was vaccinated with the fourth dose of Infanrix(lot# DTPA961A2) IM in the leg(previously reported as the first dose). The nurse reported that, according to the patient's mother, the child has been diagnosed with autism in the past few months. The reporter was unsure at what age the signs of autism occurred. Follow up information from a healthcare professional noted that the patient did not receive any vaccines at their clinic. It was noted that the patient's parents are concered because their child has autsim and are investigatin through their health department the correlation with (haemophilus B conjugate vaccine + hepatitis B vaccine recombinant. Additional information has been requested. This case is closed. Follow up info received on 3/28/02, from a registered nurse indicated that on 12/12/00 the pt was vaccinated with the foruth dose of Infanrix IM in the left (961A2). It was also reported that the vaccinations given on 12/12/00 were given by the following routes/sites: haemophilus conjugate vaccine(+)hep B vaccine recombinant IM leg, Infanrix IM leg, IPOL IM leg and MMR SC leg. The nurse reported that according to the pt's mother, the child has been diagnosed with autism in the past few months. The reporter was unsure at what age the signs of autism occurred. Additional info has been requested. Follow-up information from a RN noted that she did not have any additional informatio on this patient. The patient's family no longer lives in the county an he is not seen in this office. No further information is available.
Got 2mo. shots that am. By evening, slight rash on leg, fussy and crying, low grade temp. Pink raised rash spread over lower leg on left and then to chest and abdomen on left side. Seen x2 no treatment except Benadryl and Tylenol resolved within two days.
Burning at bedtime.  The next day swelling, redness and warmth from top of shoulder down to elbow.  Burning, tenderness and discomfort with ROM.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient tested negative for antibodies, and experienced suspected immunological vaccine failure.  Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210805141.; Sender's Comments: V0-20210805266-COVID-19 VACCINE aD26.Cov2.s-Suspected Immunological Vaccine Failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Patient presented to ED on 8/28, 10 days after first immunization, with angioedema - right side tongue swelling and difficulty swallowing, itching on arm and buttock. Rash (hives) to abdomen, right arm, right hand, left buttock. Treated with benadryl, EpiPen, famotidine and dexamethasone. Patient symptoms resolved then she had her 2nd dose on 9/16 and presented on  9/25 with right lower lip swelling, abdominal swelling and finger swelling and itching. Treated with benadryl, famotidine, dexamethasone, and montelukast.
Respiratory arrest at home after 4 days of worsening cold symptoms. Driven by family auto to Medical Center and then transfered to PICU at another hospital.
Rt arm red, swollen, firm, hot @ area of injection site for 48h after receiving Meningitis vaccine.
Fever, rash began 06/13/2003 (10 days after immunization)
Stiffness in arm at the injection site; Muscle pull; This is a spontaneous report received from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: En6204) via an unspecified route of administration in the left arm on 13March2021 at 18:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 13March2021, the patient had experienced arm stiffness at the injection site and felt like the muscle being pulled. The patient did not received any treatment for the events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event stiffness in arm and muscle pull was not recovered. No follow-up attempts are possible. No further information is expected.
I took the pfizer vaccine on Sept 19 12:15pm and 2 hrs later began spotting. Now I am currently bleeding like I am on my period with severe cramping. I am over 2 years post menopausal.
THERE WAS TOMATO REDNESS ON THE SITE OF INJECTION SPREADING ALMOST THE ENTIRE UPPER ARM ON THE FRONT AND BACK SIDE AND PAIN TO THE TOUCH. WHEN ASKED, PATIENT SAID THERE IS NO FEVER. SHE FELT SLIGHTLY NAUSEOUS BUT NOT SERIOUSLY SICK. I ADVISED HER TO USE APPLY COLDNESS ON TO SEE IF THAT WOULD ALLEVIATE THE WARM REDNESS BUT DO NOT APPLY DIRECTLY ONTO THE AFFECTED AREA BUT ON TOP OF A TOWEL.  IF NO IMPROVEMENT BY THE END OF TODAY, EITHER GO TO ER OR CALL DOCTOR.
Burning and soreness of injection site; pain and swelling of lymph nodes in armpit area
on same day of vax pt devel a localized red rash & cried for a prolonged time (all noc) w/no relief;also had a knot @ inj site;
Patient received a double dose of Fluzone Quadrivalent High Dose with no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via  (Reference number- 00334421) and transmitted to Sanofi on 27-Oct-2020.  This case involves a 76 years old male patient who was inadvertently administered with double dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ510AB, expiration date: 30-Jun-2021, dose: 0.7 mL) via unknown route at an unknown administration site for prophylactic vaccination on 27-Oct-2020 (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on the same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 15-SEP-2016, the patient was vaccinated with M-M-R II (lot number: L036851), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
Seems to be resolving.  Apply cold compress 3x TID and may take TYLENOL if pain occurs.
On December 12th, I experienced HIVES. The hives started on my back and within 30mins my entire body was covered in hives. I had big whelps all over my body. I would wake up throughout the night and feel a tingling sensation and the hives got worse everyday. I took medication and slept hoping the hives would go away. I work at a hospital and was advised to take allegra and zyrtec. I went to a dermatologist and was given an allergy test and it was negative. The doctor advised me this was in correlation to the vaccine. I have to take medication daily to control the hives. The hives has not completely cleared up but more controlled as long as I take the allegra and zyrtec daily.
This spontaneous report as received from a other health professional refers to a 12 month old patient. On 01-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.